Suit alleges da Vinci robot burned patient's intestine in Florida surgery

What happened

According to a complaint filed in federal court in Florida, a woman underwent surgery for colon cancer at Baptist Health Boca Raton Regional Hospital in September 2021. The operation was performed with a da Vinci surgical robot and accessories made by Intuitive Surgical.

The complaint alleged that during the procedure the patient suffered a thermal injury to her small intestine that caused a perforation. It said she needed a series of further medical procedures and died on February 7, 2022 as a result of the injury.

The lawsuit attributed the injury to stray electrical energy from the robot’s instruments, a phenomenon the complaint described as arcing, which it said can burn tissue outside the surgeon’s field of view. These are the plaintiff’s allegations; the case ended before any trial or finding on what caused the injury.

The system involved

The da Vinci is a multi-armed surgical system made by Intuitive Surgical of Sunnyvale, California. A surgeon controls the instruments from a console; the robot does not act on its own. The court’s order in the case identifies the system as a da Vinci Xi and the instrument at issue as the company’s monopolar curved scissors, which use electrical energy to cut and cauterize tissue.

The complaint cited a July 2013 FDA warning letter to Intuitive and earlier complaints about cracks in the insulating tip covers used on those scissors. Neither the hospital nor the surgeon was named as a defendant.

Investigation and response

The patient’s husband sued Intuitive Surgical on February 6, 2024 for negligence, design defect, failure to warn and related claims, seeking compensatory and punitive damages and a jury trial. The suit also alleged that Intuitive under-reported injuries to the FDA and did not adequately train surgeons. Intuitive did not respond to NBC News’ request for comment at the time and moved to dismiss the case in court.

After two amended complaints, the judge ruled on July 11, 2024 that claims premised on a failure to report adverse events to the FDA were preempted by federal law and that a strict-liability claim for failing to warn the patient’s doctor could not proceed, while allowing the remaining claims to go forward. A stipulation of dismissal with prejudice was filed the same day and the case was closed on July 12, 2024. Law360 reported that the widower agreed to drop the suit.

What is not established

Whether the robot or its instruments caused the injury was never determined by a court. The terms on which the suit was dropped, including whether there was a settlement, are not public. The exact date of the surgery is not given in the complaint beyond September 2021.