'Unreasonably Dangerous' Surgical Robot Fatally Burned Cancer Patient, Lawsuit Alleges

The widower of Sandra Sultzer is suing the manufacturer of the remote device that he says burned her during surgery, causing her death

<p>Getty</p> A woman lies in a hospital bed.


A woman lies in a hospital bed.

A woman died when a surgical robot burned her during colon cancer surgery, eventually causing her death, a new lawsuit against the manufacturer of the surgical robot claims.

When Sandra Sultzer underwent surgery for colon cancer in September 2021 at Baptist Health Boca Raton Regional Hospital in Florida, doctors used a “da Vinci robot,” which the lawsuit explains is “a multi-armed, remote controlled, surgical device,” made by Intuitive Surgical, Inc.

“These instruments consist of forceps, scissors, scalpels and other surgical tools. Some of these instruments use electrical energy to cut and cauterize living body tissue,” the lawsuit claims.

It’s that electrical energy that caused her death, her widower, Harvey Sultzer, charges in the lawsuit, which says the manufacturer knew the insulation used on its electrosurgical instruments was "insufficient to reliably prevent electricity from leaking into the body and causing internal burns to patients.”

<p>Google Maps</p> Baptist Health Boca Raton Regional Hospital.

Google Maps

Baptist Health Boca Raton Regional Hospital.

This isn’t the first time Intuitive Surgical’s devices caused injury or death, the lawsuit alleges.

According to a recent SEC filing by ISI, “The Company is currently named as a defendant in a number of individual product liability lawsuits filed in various state and federal courts. The plaintiffs generally allege that they or a family member underwent surgical procedures that utilized the da Vinci surgical system and sustained a variety of personal injuries and, in some cases, death as a result of such surgery. Several of the filed cases have trial dates in the next 12 months.”

Mrs. Sultzer’s death, the lawsuit claims, was caused by “thermal injury [to the] small intestine, causing a perforation which required subsequent medical intervention and caused permanent physical and emotional injuries, and ultimately her death.”

According to the lawsuit, she “continued to have abdominal pain and fever after the da Vinci surgery, and additional surgeries were required to close the perforation.”

Mrs. Sultzer died in February 2022, “as a direct and proximate result of the injuries she suffered during the September 2021 da Vinci surgery," the lawsuit claims.

Related: Lawsuit Accuses Washington Hospital of Removing and Misplacing Man's Potentially Cancerous Bladder Tumor

The problem, the lawsuit claims, is that the device is not only poorly designed, but those who operate it aren’t properly trained.

<p>Robert Michael/dpa/picture alliance/Getty</p> The da Vinci surgical system.

Robert Michael/dpa/picture alliance/Getty

The da Vinci surgical system.

“Had ISI safely designed its product so that stray electrical energy would not burn the insides of patients without the knowledge or control of the operating surgeons, the small intestine injury to Mrs. Sultzer would not have happened, and she would not have died,” the lawsuit claims. ”Had ISI adequately warned about the problems with its monopolar scissors, the injuries Mrs. Sultzer sustained would not have happened, and she would not have died. The same is true had ISI properly trained the surgeons.”

Baptist Health Boca Raton Regional Hospital is not named as a defendant in the lawsuit.

According to NBC News, “Intuitive does offer a training program, but an NBC News investigation in 2018 found that it can’t legally require surgeons to complete it.”

In 2016, the FDA announced a recall of a da Vinci model due to a “software anomaly.” And last March, another recall was announced by the FDA, citing risk of “tissue injury” from “ballscrew failure.”

This week, the president of Intuitive Surgical sold more than 80,000 shares of the company for a total price of more than $31 million, according to SEC filings, Yahoo! Finance reported.

Related: Two Women Sue Plastic Surgeon Who They Claim Operated on Them While Drunk, Leaving Them 'Disfigured' (Exclusive)

The complaint also accuses the company of intimidating hospitals into using the device.

The lawsuit claims that “ISI, through intimidation and market management, bullies hospitals and physicians to purchase and use the robot. ISI’s da Vinci was unreasonably dangerous for use in Mrs. Sultzer’s procedure; she was unnecessarily injured and ultimately died as a result.”

PEOPLE has reached out to both Intuitive Surgical, Inc., and to Baptist Health Boca Raton Regional Hospital, and is awaiting comment.

Never miss a story — sign up for PEOPLE's free daily newsletter to stay up-to-date on the best of what PEOPLE has to offer, from celebrity news to compelling human interest stories.

For more People news, make sure to sign up for our newsletter!

Read the original article on People.