In a legal action initiated in Florida, it's been alleged that a woman passed away due to complications from a surgery where a robotic device, identified as the da Vinci, reportedly caused severe damage to her small intestine by burning and creating a tear.
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Sandra Sultzer, a resident of Boca Raton, opted for surgical treatment using the da Vinci robotic device in September 2021 after being diagnosed with colon cancer.
Not long after the surgical procedure, Sultzer experienced significant abdominal pain and fever, which were traced back to a tear in her small intestine that occurred during the operation.
The lawsuit has been brought forward by her spouse, Harvey Sultzer, who asserts that despite undergoing additional medical procedures aimed at repairing the tear, Sandra Sultzer succumbed to the injuries related to her small intestine in February 2022.
The robotic device has been used in thousands of procedures.
Credit: YouTube/Intuitive Surgical
Harvey Sultzer is pursuing legal action against Intuitive Surgical, the company responsible for the da Vinci device, seeking damages for what he claims was the company's awareness of insulation flaws in the device.
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These flaws could potentially allow electricity to escape and cause burns to internal organs.
He accuses Intuitive Surgical of not only withholding information about the risks associated with the da Vinci from the Sultzers and the general public but also criticizes the company for distributing the device to hospitals inexperienced in robotic surgery and for not ensuring surgeons receive adequate training in its use.
The legal claim highlights that Intuitive Surgical has been the recipient of thousands of reports detailing injuries and malfunctions linked to the da Vinci across several years, alleging that the company has consistently failed to report these incidents properly to the Food and Drug Administration (FDA).
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In a 2014 report to the Securities and Exchange Commission, Intuitive Surgical disclosed its involvement in approximately 93 lawsuits, with plaintiffs claiming personal injuries or death following surgeries utilizing the da Vinci Surgical System.
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Furthermore, a 2023 report from Intuitive Surgical acknowledged the company's defense in "a number of individual product liability lawsuits."
Intuitive Surgical has been named a defendant in multiple lawsuits.
Credit: YouTube/Intuitive Surgical
An investigation conducted by NBC News in 2018 revealed that although Intuitive Surgical offers a training program for the da Vinci, there are no legal requirements for surgeons to complete this training.
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The investigation uncovered 2,000 injury reports and 274 death reports related to the da Vinci within the decade leading up to 2018.
More than a dozen patients shared with NBC News their experiences of burns or other injuries sustained during operations involving the robotic device.
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In response to these allegations, Intuitive Surgical stated:
"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."