A wrongful death lawsuit filed in Florida has claimed a local woman died after a robotic device burned and tore a hole in her small intestine.
Sandra Sultzer, from Boca Raton, underwent the surgery with the robotic device known as the da Vinci in September 2021 after she had been diagnosed with colon cancer.
Shortly after the procedure, Sultzer developed abdominal pain and fever as a result of a tear to her small intestine which she had suffered during the surgery.
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The lawsuit, filed by her husband Harvey Sultzer, claims Sultzer needed additional procedures to close the tear, but that she ultimately died in February 2022 due to the small intestine injury.
Harvey is suing the maker of the device, Intuitive Surgical, for damages, claiming the company knew the da Vinci had insulation problems which might cause electricity to leak out and burn internal organs.
The suit claims Intuitive Surgical failed to disclose the risk to the Sultzers or to the public in general.
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It further accuses the company of selling the device to hospitals which have no experience in robotic surgery, and of failing to properly train surgeons on how to use the device.
The lawsuit claims Intuitive Surgical has received thousands of reports about injuries and defects associated with the da Vinci over a number of years, and accuses it of having 'systematically underreported' injuries to the Food and Drug Administration.
In 2014, Intuitive Surgical filed a report with the Securities and Exchange Commission which said it was a defendant in around 93 lawsuits.
According to the report, the plaintiffs involved in the suits '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'.
Another report filed by Intuitive Surgical in 2023 stated that it was a defendant in 'a number of individual product liability lawsuits'.
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In 2018, an NBC News investigation found that while Intuitive does offer a training program, it can’t legally require surgeons to complete the training.
The publisher also identified 2,000 reports of injury, and 274 reports involving deaths, relating to the da Vinci in the 10 years proceeding 2018.
In total, more than a dozen patients told NBC News they had suffered burns or injuries during procedures involving the device.
At the time, Intuitive responded: “While any surgery regardless of modality carries risk, the best evidence of the safety and efficacy of robotic-assisted surgery can be found in the more than 15,000 peer-reviewed scientific publications that are fully grounded in scientific method and that, in aggregate, support the safety and efficacy of our systems."
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UNILAD has contacted Intuitive Surgical for comment.
Topics: US News, Health, Technology