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John R. Fischer, Senior Reporter | February 19, 2024
da Vinci Surgical System (Photo courtesy of Intuitive)
A routine colon cancer procedure led to a woman’s death after the robotic device that doctors used burned a hole in her small intestine, says her husband in a wrongful death lawsuit against Intuitive Surgical, the company that designed the solution.
Sandra Sultzer, of Delray Beach, Florida, experienced abdominal pain and fever following her surgery in September 2021 at Baptist Health Boca Raton Regional Hospital, where providers used the da Vinci surgical robot to operate on her. She died in February 2022,
according to the Tampa Bay Times.
Harvey Sultzer asserts that his wife’s death was caused by a stray electrical arc from the robot, and that the blame lies with Intuitive for failing to fix insulation problems that risked allowing the electricity to leak out and “burn the insides of patients without the knowledge or control of the operating surgeons,” he said in his suit filed in the U.S. District Court in West Palm Beach.
The incident, he says, was not an isolated one, and subjected Sultzer to multiple other surgeries to repair the damage as well as physical and emotional injury that led to her death. He accuses the company of failing to disclose the safety flaws to his wife or the public, and of selling the robot to hospitals with no experience in robotic surgery and not training surgeons on how to safely use the da Vinci system.
First released in 1999, the da Vinci system is a multi-armed surgical tool that doctors control remotely via an onboard camera, using forceps, scissors, scalpels, and other surgical tools. Most of its instruments are disposable or can be used for a limited number of times before they need to be replaced, meaning that the company relies on high surgery volumes to make a profit off the device.
According to a 2018 NBC News investigation, doctors recommend it because of "less downtime, less scarring, and a less than 3 percent complication rate,” but are not required to take part in a training program offered by Intuitive on its safe use.
Additionally, thousands of injury reports have pointed to defects with the device, including hundreds filed between 2009 and 2011 that alleged there were cracks and slits in the rubber tip covering its metal instruments that allowed the electricity to escape without the surgeon's being aware. In Sultzer’s suit, he says the company has “systematically underreported” these injuries to the FDA.
