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Inside the ‘adult day-care center’: How aides try to control and coerce Trump

During the campaign, when President Donald Trump’s team wanted him to stop talking about a certain issue — such as when he attacked a Gold Star military family — they sometimes presented him with polls demonstrating how the controversy was harming his candidacy.

During the transition, when aides needed Trump to decide on a looming issue or appointment, they often limited him to a shortlist of two or three options and urged him to choose one.

And now in the White House, when advisers hope to prevent Trump from making what they think is an unwise decision, they frequently try to delay his final verdict — hoping he may reconsider after having time to calm down.

When Sen. Bob Corker, R-Tenn., described the White House as “an adult day-care center” on Twitter last week, he gave voice to a certain Trumpian truth: The president is often impulsive, impetuous and difficult to manage, leading those around him to find creative ways to channel his energies.

Teen accused in Roger Trindade’s death now facing adult charges

A 16-year-old boy accused of manslaughter in the beating death of Roger Trindade in Winter Park last year is now being charged as an adult, according to the Orange-Osceola State Attorney’s Office.

The decision comes after Simeon Hall’s arrest earlier this month in a separate assault case.

“I feel a certain relief, but also sadness,” Roger’s mother Adriana Thomé wrote in an email to the Orlando Sentinel. “What I see is these teens were in Winter Park making a lot of fuss and no one thought they were violent. The bottom line is that they are dangerous.”

Simeon is now at the Orange County Jail. A judge said she had “ongoing concerns about the safety of the community” and denied him bond on Tuesday morning.

Pensacola child dies after 325-pound adult sat on her as punishment






A child died in Florida after her 325 pounds cousin sat on her for over 10 minutes as a form of punishment.

A 9-year-old Pensacola child died Saturday after her 325-pound cousin allegedly sat on her as punishment for misbehavior, according to an Escambia County Sheriff’s Office report.

Veronica Green Posey, 64, was charged with homicide and cruelty toward a child after paramedics responded to a cardiac arrest call at 1:35 p.m. Saturday in the 300 block of Bryant Road. Upon arrival, the victim, Dericka Lindsay, was found to be unresponsive and was transported to Baptist Hospital, where she was pronounced dead.

Based on the arrest report, Posey told the responding deputy she sat on Dericka as a discipline “for being out of control.” During the course of the punishment, the report states Dericka told the adults she could not breathe. After standing up and discovering the child was unresponsive, Posey called 911 and started CPR.

More: Man gets life in prison for reoffending

The report later states Posey informed the deputy she weighed about 325 pounds.

Additionally, Grace Joan Smith, 69, and James Edmund Smith, 62, were arrested and charged with child neglect for failing to report the abuse. Grace Smith has also been charged with cruelty toward a child. The report named the Smiths as the parents of Dericka and Posey as the Smiths’ niece.

According to Grace Smith’s arrest report, she called Posey to her house for assistance with disciplining Dericka. Grace Smith told the deputy Posey struck Dericka with a ruler and a metal pipe, before Dericka ran to an armchair.

In James Smith’s arrest report, he told the deputy Posey sat on Dericka in the armchair for an estimated 10 minutes before Dericka complained of not being able to breathe. He told the deputy Posey continued to sit on the child for another two minutes before standing up and finding the child unresponsive.

More: Pensacola woman charged with homicide in death of child, 2 others arrested

In an emailed statement to the News Journal, Mike Carroll, secretary of the Florida Department of Children and Families, said the family had a previous interaction with the state’s child welfare system.

“Dericka’s death is appalling and DCF will continue coordinating with the Escambia County Sheriff’s Office to hold anyone responsible for her death accountable,” Carroll’s statement read. “As the family has a prior interaction with the child welfare system, a thorough quality assurance review will be conducted to review all prior interactions this family has had with the child welfare system.”

According to Escambia County’s jail records, Posey’s bond was set at $125,000, and she has been released. Grace Smith’s bond was set at $75,000, and James Smith’s bond was set at $50,000. As of 3 p.m. Monday, jail records showed both were still in jail.

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News Roundup: Inside the ‘adult day care center’ of the White House

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A Gun to His Head as a Child. In Prison as an Adult.

“Childhood trauma is a huge factor within the criminal justice system,” said Christopher Wildeman, a sociologist at Cornell University and co-director of the National Data Archive on Child Abuse and Neglect. “It is among the most important things that shapes addictive and criminal behavior in adulthood.”

Mr. Sullivan was one of 10 newly released prisoners in Connecticut whom the PBS series “Frontline” and The New York Times followed for more than a year. The state is working to reduce its prison population and improve former prisoners’ chances of successfully rejoining society. But those convicted of crimes often have complex problems that date back to childhood. More than half, including Mr. Sullivan, went back inside.

A look at their histories showed that long before they were perpetrators, many of them were victims. Seven completed a questionnaire intended to quantify childhood trauma on a scale of one to 10, including the experience of or exposure to physical and sexual abuse, drug and alcohol abuse or mental illness in the home. High scores predict a wide variety of negative outcomes. All but one of them scored four or more, indicating a substantially elevated risk of chronic disease, depression, suicide attempts, substance abuse and violence.

Mr. Sullivan scored a 9.


Bald with blue eyes, wearing his mother’s silver cross around his neck, Mr. Sullivan, 43, has two tears tattooed under his right eye, an intimate reminder of death. One is for his mother, who died of a heroin overdose when he was 21; the second is for a cousin, as close as a sister, who overdosed four years later.

What Mr. Sullivan saw, he eventually imitated. During one of Mr. Sullivan’s many trips to jail, he said, he passed his father, a fellow inmate, in the hallway.

His mother was unpredictable. “I remember her sleeping all the time, nodding out and burning holes in the floor,” he said. At first, this seemed normal. “I used to wonder why I couldn’t have a friend sleep over,” he said. “Then it was, I didn’t want to have a friend sleep over.”

He took his first sip of beer at 12 or 13 years old. By the time he was 19 — three years after quitting high school — he was, by his own estimation, an alcoholic, guzzling a 12-pack of Budweiser daily.

For the longest time, he resisted the temptation to try heroin. But so many of his friends were using. “I fell in love with the feeling of it,” he said. “It was calming and numbing and soothing, like a warm embrace.”


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Mr. Sullivan has survived almost two decades of drug and alcohol use, cycling among short-term jobs, arrests and rehab. But the pattern has taken a toll: his relationship with his three oldest children — ages 23, 21 and 17 — is tumultuous, mostly because he was an absent father. He owes about $100,000 in child support.

With Raeann, the youngest, he wanted things to be different. Though jail often kept them apart, Mr. Sullivan doted on his daughter and tried to shield her from his habits and temper. He called her “Chewy” and “Peanut,” drew her elaborate pictures and texted her every day from the halfway house where he went after his release from prison.

But he hated the restrictions of life there, with his whereabouts and spending closely monitored. Finally he walked out, even though he knew it would mean a return to prison.

Before he turned himself in, he took his last paycheck and treated Raeann to the pair of silver high-tops with fuchsia laces that she wanted for her first basketball game.

“The sneakers were important to both of us,” he said. “And I wanted to see her play.”

Outside the store, there was a tearful goodbye. “You know you can tell me anything,” he said.

But Raeann was getting older. More mature. More perceptive.


Raeann Sullivan at the house in Manchester, Conn., where she lives with her mother.

Kassie Bracken/The New York Times

When Mr. Sullivan missed her 10th birthday because he was locked up, she was forgiving. When she turned 11, he was out of jail, and the family had a birthday party. One year later, as her 12th birthday neared, Raeann finally got a good, hard look at her father’s other side.


In the mid-1990s, Dr. Vincent Felitti, the chief of Kaiser Permanente’s obesity clinic, and Dr. Robert Anda, a medical epidemiologist with the Centers for Disease Control, developed 10 questions to assess cumulative childhood stress called the Adverse Childhood Experiences, or ACE, survey. The higher the ACE score, the higher the risk of negative outcomes: Among those who scored at least four, there was a 1,220 percent increase in suicide attempts over those who scored zero.


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“This clearly showed children’s adverse experiences are a public health problem,” Dr. Anda said. “What we now know is that childhood adversity and stress can chemically change the way our brains work.”

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The changes can affect impulse control, decision making and executive functions. From there, it can be a short hop to breaking the law.

But treatment can be complicated, and patients often resist it. Scientists have been testing the theory that higher levels of childhood trauma make recovery from addiction more difficult. They are developing approaches that capitalize on the brain’s ability to rewire itself.

Some schools, hospitals and jails have incorporated this emerging understanding of trauma, shifting the question from “What is wrong with you?” to “What happened to you?”

In Connecticut, the Department of Correction offers a program to help inmates understand how trauma changes the normal stress response and how to control triggers (the program is still small, and Mr. Sullivan was not a participant). Studies show that childhood trauma increases the likelihood of arrest and that inmates report much higher rates of trauma than other adults.

“It is safe to assume that the people I deal with have experienced some kind of horrible trauma as children and adults, so for me, that is a starting point,” said Katherine Montoya, a 10-year veteran parole officer in Connecticut who works with women.

For one parolee who had been the victim of sex trafficking, Ms. Montoya worked to avoid triggering the woman’s trauma by making sure she came in contact only with female officers.


In May 2016, after serving his time following the halfway house incident, Mr. Sullivan walked out of the Enfield Correctional Institution. For about nine months, he did well, living with Raeann and her mother, Kelly Shepard, 44, whom he has known since middle school. (While it was not possible to independently verify some of Mr. Sullivan’s accounts of his childhood, Ms. Shepard said they were consistent with what he had told her.)

He found work with a construction company, and managed to shield Raeann from the worst of his temper.


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But in February, there was a bad blowup. He called Raeann and Ms. Shepard nasty names. He smashed Ms. Shepard’s cellphone.

Raeann stopped speaking to her father.

“She idolizes him. But she finally saw the other side of him, when he drinks, and she is really angry now,” said Ms. Shepard, who keeps a close watch on her daughter and makes sure she is in counseling. “He adores her, but he can’t get himself together long enough to maintain the relationship.”

Mr. Sullivan checked himself into Lebanon Pines, a rural 56-acre residential rehab facility for men. Six years before, he had been required to go to Lebanon Pines as a condition of probation. This time was voluntary. He received therapy and daily doses of methadone.


Rob Sullivan on the grounds of a rehab center in Lebanon, Conn., where he checked himself in for treatment earlier this year.

Christopher Capozziello for The New York Times

But he refused to talk in depth about his childhood trauma. And he struggles to explain why. “I just haven’t wanted to go there,” he said. “It’s painful.”

Mr. Sullivan had two decades on many fellow patients at Lebanon Pines. He was banking on his age and the high cost of street life being enough to finally break the generational cycle. Still, about six weeks before his release date, he was worried that he might not make it.

“I have never followed through on anything in my life,” he said, tears in his eyes. “It’s hard. I know if I end up back in the streets I will end up drinking and using again.”

Mr. Sullivan was right. He did not finish the program.

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Inside the ‘adult day-care center’: How aides try to control and coerce Trump

During the campaign, when President Trump’s advisers wanted him to stop talking about a certain issue — such as when he attacked a Gold Star military family — they sometimes presented him with polls demonstrating how the controversy was harming his candidacy. 

During the transition, when aides needed Trump to decide on a looming issue or appointment, they often limited him to a shortlist of two or three options and urged him to choose one.

And now in the White House, when advisers hope to prevent Trump from making what they think is an unwise decision, they frequently try to delay his final verdict — hoping he may reconsider after having time to calm down.

When Sen. Bob Corker (R-Tenn.) described the White House as “an adult day-care center” on Twitter last week, he gave voice to a certain Trumpian truth: The president is often impulsive, mercurial and difficult to manage, leading those around him to find creative ways to channel his energies.  

Some Trump aides spend a significant part of their time devising ways to rein in and control the impetuous president, angling to avoid outbursts that might work against him, according to interviews with 18 aides, confidants and outside advisers, most of whom insisted on anonymity to speak candidly.

White House Chief of Staff John F. Kelly takes questions during a news briefing at the White House Thursday. (Jabin Botsford/The Washington Post)

“If you visit the White House today, you see aides running around with red faces, shuffling paper and trying to keep up with this president,” said one Republican in frequent contact with the administration. “That’s what the scene is.” 

The White House dismissed Corker’s suggestion that administration officials spend their days trying to contain the president. The point was highlighted last week in an unusual briefing by White House Chief of Staff John F. Kelly, who sought to tamp down reports that he was focused on attempting to control Trump.  

“I was not brought to this job to control anything but the flow of information to our president so that he can make the best decisions,” Kelly told reporters. “So, again, I was not sent in to — or brought in to — control him.”

Kelly also praised Trump as “a decisive guy” and “a very thoughtful man” whose sole focus is on advancing American interests. “He takes information in from every avenue he can receive it,” Kelly said. “I restrict no one, by the way, from going in to see him. But when we go in to see him now, rather than onesies and twosies, we go in and help him collectively understand what he needs to understand to make these vital decisions.” 

Trump is hardly the first president whose aides have arranged themselves around him and his management style — part of a natural effort, one senior White House official said, to help ensure the president’s success. But Trump’s penchant for Twitter feuds, name-calling and temperamental outbursts presents a unique challenge.

One defining feature of managing Trump is frequent praise, which can leave his team in what seems to be a state of perpetual compliments. The White House pushes out news releases overflowing with top officials heaping flattery on Trump; in one particularly memorable Cabinet meeting this year, each member went around the room lavishing the president with accolades.

Senior administration officials call this speaking to an “audience of one.”

One regular practitioner is Treasury Secretary Steven Mnuchin, who praised Trump’s controversial statements made after white supremacists had a violent rally in Charlottesville and also said he agreed with Trump that professional football players should stand during the national anthem. Neither issue has anything to do with the Treasury Department.

Former treasury secretary Larry Summers wrote in a Twitter post that “Mnuchin may be the greatest sycophant in Cabinet history.”

Especially in the early days of his presidency, aides delivered the president daily packages of news stories filled with positive coverage and Trump began meetings by boasting about his performance, either as president or in winning the White House, according to one person who attended several Oval Office gatherings with him. 

Some aides and outside advisers hoping to push their allies and friends for top postings, such as ambassadorships, made sure their candidates appeared speaking favorably about Trump in conservative news outlets — and that those news clippings ended up on the president’s desk.

H.R. McMaster, the president’s national security adviser, has frequently resorted to diversionary tactics to manage Trump. In the Oval Office he will often volunteer to have his staff study Trump’s more unorthodox ideas. When Trump wanted to make South Korea pay for the entire cost of a shared missile defense system, McMaster and top aides huddled to come up with arguments that the money spent defending South Korea and Japan also benefited the U.S. economy in the form of manufacturing jobs, according to two people familiar with the debate.

“He plays rope-a-dope with him,” a senior administration official said. “He thinks Trump is going to forget, but he doesn’t. H.R.’s strategy is to say, ‘Let us study that, boss.’ He tries to deflect.”

Sam Nunberg, who worked for Trump but was fired in 2015, said he always found him to be “reasonable,” but noted that delaying a decision often helped influence the outcome. 

“If [Trump] wanted to do something that I thought could be problematic for him, I would simply, respectfully, ask him if we could possibly wait on it and then reconsider,” Nunberg said. “And the majority of the time he would tell me, ‘Let’s wait and reconsider,’ and I would prepare the cons for him to consider — and he would do what he wanted to do. Sometimes he would still go with the decision I may have disagreed with, and other times he would change his mind.”

 Of course, the president chafes at the impression that his aides coddle him or treat him like a wayward teenager. During the campaign, after reading a story in the New York Times that said Trump’s advisers went on television to talk directly to him, the candidate exploded at his then-campaign chairman, Paul Manafort, chastising his top aide for treating him like “a baby,” according to “Devil’s Bargain,” a book that chronicles Trump’s path to the presidency.

Some aides and advisers have found a way to manage Trump without seeming to condescend. Perhaps no Cabinet official has proven more adept at breaking ranks with Trump without drawing his ire than Defense Secretary Jim Mattis, who has disagreed with his boss on a range of issues, including the effectiveness of torture, the importance of NATO and the wisdom of withdrawing from the Iran nuclear deal. 

 The president appreciates how Mattis, a four-star Marine general, speaks to him candidly but respectfully and often plays down disagreements in public. A senior U.S. official said that Mattis’s focus has been on informing the president when they disagree — before the disagreements go public — and maintaining a quiet influence. 

Unlike his fellow Cabinet secretaries, Mattis has also gone out of his way not to suck up to the president — a stance made easier perhaps by his four decades in uniform and his combat record.

At the laudatory Cabinet meeting this summer, he was the lone holdout who did not lavish praise on the president. Instead, Mattis said it was “an honor to represent the men and women of the Department of Defense.”

Mattis has also worked to get on Trump’s good side by criticizing the media for putting too much emphasis on his disagreements with Trump. “I do my best to call it like I see it,” he told reporters in late August. “But, right now, if I say six and the president says half a dozen, they are going to say I disagree with him. You know? So, let’s just get over that.”

When he has broken with the president, Mattis has done it in as low-key a way as possible. This month he said it was in America’s interest to stick with the Iran nuclear agreement — which Trump called “the worst deal ever” — but voiced the opinion only in answer to questions from the Senate Armed Services Committee.

Corker’s quip comparing the White House to a day-care center on Oct. 8 came in the middle of a feud between him and Trump, who attacked Corker by tweeting that the retiring senator “didn’t have the guts” to run for reelection and had begged for his endorsement. Corker fired back on Twitter and in a New York Times interview, warning that Trump was running the White House like “a reality show” and that his reckless threats against other nations could put the country “on the path to World War III.”

“I know for a fact that every single day at the White House, it’s a situation of trying to contain him,” Corker said, adding later that most GOP lawmakers “understand the volatility that we’re dealing with and the tremendous amount of work that it takes by people around him to keep him in the middle of the road.”

Trump seems to hold many Republican lawmakers, and some members of his own Cabinet, in similarly low regard. Several people who have met with Trump in recent weeks said he has a habit of mocking other officials in Washington, especially fellow Republicans.

In a meeting at the White House last month with House and Senate leaders from both parties, for instance, Trump upset Senate Majority Leader Mitch McConnell (R-Ky.) and House Speaker Paul D. Ryan (R-Wis.) by cutting a deal with Democrats. In subsequent days behind closed doors, the president mocked the reactions of McConnell and Ryan from the meeting with an exaggerated crossing of his arms and theatrical frowns.

Former House speaker Newt Gingrich, an informal Trump adviser, scoffed at the suggestion that Trump needs to be managed by his advisers as parents would handle an unruly child. 

“He’s the president of the United States. Period. Is he an unusual president? Sure. But so was Andrew Jackson, Abraham Lincoln, and Theodore Roosevelt,” Gingrich said. “You guys in the media would have had a field day with them, too.”

 Still, Corker’s comments underscored the uneasy dichotomy within the West Wing, where criticism of the president’s behavior is only whispered.

“They have an on-the-record ‘Dear Leader’ culture, and an on-background ‘This-guy-is-a-joke’ culture,” said Tommy Vietor, who served as a spokesman for President Barack Obama. “I don’t understand how he can countenance both.” 

Robert Costa, Damian Paletta and Philip Rucker contributed to this report. 

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Adult, 2 teens arrested for delivery driver robbery in Delaware

Police say 19-year-old Jonathan Snyder was among a group of teens who lured a Domino’s delivery driver in Wilmington, Delaware, and then robbed him.

Investigators say two 17-year-olds wearing Halloween masks and holding guns jumped out from nearby bushes.

Police say the two demanded the pizza from the driver and cash from Snyder, who they say pretended to also be a victim.

The three were arrested after being stopped for an unrelated traffic offense.

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North Dakota adult education programs deal with budget cuts

Adult education programs around North Dakota are dealing with a one-third cut to their funding.

About 10 percent of the state’s population between the ages of 16 and 55 don’t have a high school diploma or GED diploma, the Minot Daily News reported.

Many people don’t understand how valuable adult education is, said Valerie Fischer, the state director of adult education.

Supporters of adult education programs say investing in them can lead to big benefits, since those with diplomas earn more and are less likely to rely on welfare programs. Adult education officials say the children of GED earners also tend to have better educational outcomes.

It’s a “win-win” for the state and for families, said Jennifer Kraft, the director of the Minot Adult Learning Center.

The funding cut has led to a decrease in programs offered at the center’s satellite sites.

Services are now offered online and at the center in Minot, Kraft said. But the geographical distance can be an obstacle for people who need the service but live in rural areas.

“We do what we can with the money that we have,” Kraft said.

Kraft said she’s compiling information about the region’s needs and hopes to offer more services to meet those demands if funding becomes available.

The state reduced the number of adult learning centers from 13 to eight a few years ago when it switched to a regional plan.

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Pimples are for teenagers. So how come I’m still getting them?!

Pimples are a scourge of teenage years, right? But anyone who has looked in the mirror and found an unwelcome zit in their 20s, 30s or even later can tell you that clear skin isn’t always one of adulthood’s privileges.

A stray pimple — or ongoing breakouts — aren’t unusual for adult women, says Nada Elbuluk, a dermatologist and assistant professor at NYU Langone Health. For many, they’re the norm. A 2008 study found that more than 50 percent of women in their 20s, 35 percent of women in their 30s, 26 percent of women in their 40s and 15 percent of women in their 50s reported experiencing acne. That’s more than men — thanks in part, says Elbuluk, to hormones that influence oil production in women. (Teenage boys are more likely to experience acne than teenage girls.)

Acne occurs when hair follicles get blocked by dead skin cells or oil. Bacteria thrive in clogged pores and when inflammation results, normally calm skin can erupt into cysts, pimples and blackheads. Stress, hormonal irregularities, pregnancy, menopause, genetics and some dietary factors can spur breakouts. Other times, they just happen. “It’s often very frustrating,” says Elbuluk. “There’s not really any way to predict.”

Though adult acne can be a holdover from the teen years, it often differs from the breakouts on teenage faces. Teens tend to get acne in their “T zone” (across the forehead, nose and upper chin); adults usually get it in what dermatologists call the “U zone” (around the cheeks, mouth and chin).

The hormonal acne that women get tends to cluster around the chin and jaw line. And while teens tend to get inflamed whitehead-type zits, adult women are more likely to experience bumps under the skin. It’s unclear what accounts for this difference. The menstrual cycle can cause acne, but so can hormonal imbalances.

Women with acne have plenty of treatment options, including over-the-counter benzoyl peroxide and salicylic acid, prescription options such as topical creams, oral antibiotics and birth control pills, and procedures such as chemical peels.

But think twice before heading to your medicine cabinet for a “natural” remedy, Elbuluk says. “I’ve had patients who have tried lemon juice, apple cider vinegar or various oils,” she says. “But there’s no scientific data behind a lot of that stuff.” Other purported remedies, such as an iPhone app that claimed to heal acne but was smacked down by the Federal Trade Commission as essentially snake oil in 2012, don’t do anything at all.

Elbuluk recommends you visit a board-certified dermatologist instead of turning your face into a science experiment. “Even a natural-seeming product can cause irritation to the skin,” she says. Dermatologists can usually help find a treatment you can afford, she adds, and if the visit reveals an underlying health issue, your entire body may thank you.

And don’t think you’re in the clear once you hit menopause: Some post-menopausal women get acne, too.

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Press Announcements > FDA clears new robotically-assisted …

Today, the U.S. Food and Drug Administration cleared the Senhance System, a new robotically-assisted surgical device (RASD) that can help facilitate minimally invasive surgery.

“Minimally invasive surgery helps reduce pain, scarring and recovery time after surgery,” said Binita Ashar, M.D., director of the Division of Surgical Devices in the FDA’s Center for Devices and Radiological Health. “RASD technology is a specialized innovation in minimally invasive surgery designed to enhance the surgeon’s access and visualization within confined operative sites.” 

RASD, sometimes referred to as robotic surgery, is one type of computer-assisted surgical system. RASD enables the surgeon to use computer and software technology to control and move surgical instruments through one or more tiny incisions in the patient’s body (laparoscopic surgery) in a variety of surgical procedures or operations. The benefits of RASD technology may include its ability to facilitate minimally invasive surgery and assist with complex tasks in confined areas of the body. The device is not actually a robot because it cannot perform surgery without direct human control.

The design of the Senhance System allows surgeons to sit at a console unit or cockpit that provides a 3-D high-definition view of the surgical field and allows them to control three separate robotic arms remotely. The end of each arm is equipped with surgical instruments that are based on traditional laparoscopic instrument designs. The system also includes unique technological characteristics: force feedback, which helps the surgeon “feel” the stiffness of tissue being grasped by the robotic arm; eye-tracking, which helps control movement of the surgical tools and laparoscopic-type controls similar to traditional surgical equipment.

The Senhance System is intended to assist in the accurate control of laparoscopic instruments for visualization and endoscopic manipulation of tissue including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, mobilization and retraction in laparoscopic colorectal surgery and laparoscopic gynecological surgery. The system is for use on adult patients by trained physicians in an operating room environment.

The manufacturer conducted a clinical study of 150 patients undergoing various gynecological operations with the Senhance System. Clinical outcomes were compared to those described in eight peer-reviewed research publications involving more than 8,000 gynecological operations performed in real-world settings (real-world evidence) using another RASD. In addition, the manufacturer submitted Senhance System operative results involving 45 patients undergoing colorectal procedures in a real-world setting and compared the results to those from peer-reviewed research publications describing the real-world device experience. The FDA concluded that these study data, supported by real-world evidence, along with performance testing under simulated use and worst-case scenario conditions, demonstrated the substantial equivalence of the Senhance System to the da Vinci Si IS3000 device for gynecological and colorectal procedures.

The Senhance System was reviewed through the premarket clearance (510(k)) pathway. A 510(k) notification is a premarket submission made by device manufacturers to the FDA to demonstrate that the new device is substantially equivalent to a legally marketed predicate device.

The FDA granted clearance of the Senhance System to TransEnterix Surgical Inc.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.


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