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- A man is suing the maker of a surgical robot, claiming it burned and tore his wife's small intestine.
- In his complaint, Harvey Sultzer said his wife died as a result of her surgical injuries.
- "ISI's da Vinci was unreasonably dangerous for use in Mrs. Sultzer's procedure," the lawsuit said.
A man is suing the maker of a surgical robot, claiming it burned and tore his wife’s small intestine during surgery, ultimately resulting in her death.
In a complaint filed on Tuesday in the US District Court for the Southern District of Columbia, Harvey Sultzer said his wife Sandra Sultzer experienced health complications following a procedure involving a da Vinci surgical robot from Intuitive Surgical, or ISI.
NBC News was the first to report on the lawsuit.
Sultzer underwent surgery to treat her colon cancer at Baptist Health Boca Raton Regional Hospital in September 2021, per court records.
During the surgery, she suffered a thermal injury to her small intestine, according to the lawsuit, resulting in a perforation that required surgical intervention, caused permanent physical and emotional traumas, and ultimately led to her death.
It's not the first time this has happened to a patient who underwent surgery with this robot, the plaintiff’s lawsuit said, citing SEC filings.
According to SEC filings, the company is "currently named as a defendant in approximately 93 individual product liability lawsuits filed in various state and federal courts by plaintiffs who 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."
The plaintiff's lawsuit claimed that ISI received hundreds of reports about injuries and defects related to da Vinci procedures.
Among the most serious injuries, the plaintiff said, were burns to internal organs brought about by the robot's instruments.
ISI "systematically underreported" the severity of these injuries to the Food and Drug Administration, it claimed.
Most cases focused on a rubber sleeve attached to the end of certain da Vinci metal instruments as an insulator to prevent electricity from escaping, per the lawsuit.
Cracks or slits prevented the tip cover accessories from effectively insulating the metal instruments and allowed electricity or sparks to escape, it said.
This would damage blood vessels and organs without the medical team's knowledge, it alleged.
The lawsuit said that if ISI had safely designed its product and warned about these defects, Sultzer would not have suffered her injury.
“ISI’s da Vinci was unreasonably dangerous for use in Mrs. Sultzer’s procedure; she was unnecessarily injured and ultimately died as a result,” the lawsuit read.
ISI did not immediately respond to Business Insider's request for comment.
Sultzer is seeking damages and all such other relief as the court deems just and proper on the grounds of negligence and product liability, including design defect and failure to warn, it said.