A woman from Florida allegedly died after a surgical robot burned a hole in her small intestine, according to a lawsuit filed by her husband.
Boca Raton resident Sandra Sultzer died at the age of 78 in 2022 after having undergone a surgical procedure for colon cancer.
The surgery was performed using a 'da Vinci' robot, which has four arms and is operated by a doctor using a camera, as well as a surgeon who moves the robot's arms using a console with a joystick and foot pedals.
The suit alleges that some of the rubber sleeves around the arms had cracks in them, allowing electrical currents to escape and burn tissues they were not supposed to, according to reports from TMZ.
The surgery took place in September 2021 at Baptist Health Boca Raton Regional Hospital and Sultzer's husband alleges that it is the after-effects of this that eventually caused her death after a hole was burned in her small intestine.
Sultzer's husband claims that while the robot is designed to cut incisions as small as a dime, with precise movements to minimize blood loss and trauma from the larger incisions used for traditional surgery, cracks in the rubber sleeves on the arms meant other parts of her internal organs were burned without the surgical team realizing.
This, he says, led to a deadly internal leak which ended up claiming Sultzer's life.
He filed the suit against Intuitive Surgical Inc., the company that makes the da Vinci robot, alleging that it failed to adequately warn of the risk of this happening.
Sultzer's husband claims that the risks should have been known from "thousands of injury and defect reports" about the device, alleging that it has not been built safely or tested extensively enough to avoid risks of burns.
The lawsuit also alleged that the company failed to adequately train doctors in how to use the device effectively, meaning the odds of a potentially fatal error during surgery were raised.
One of the robot's arms holds a camera, or laparoscope, while the other three are fitted with surgical tools such as scalpels or forceps.
The arms are wrapped with rubber sleeves to prevent electricity from leaking anywhere it is not directed at, however, the suit alleges that cracks in these were how a hole ended up burned in Sultzer's small intestine, which allegedly happened outside the doctor's field of vision, per the Daily Mail.
A hole in the small intestine can cause grave complications - and even death - due to digestive enzymes or bile leaking out and leading to infection, which can ultimately cause sepsis.
The lawsuit stated: "Had ISI safely designed its product so that stray electrical energy would not burn the insides of patients without the knowledge or control of the operating surgeons, the small intestine injury to Mrs. Sultzer would not have happened, and she would not have died."
Intuitive Surgical said that the da Vinci robots have been used in around 12 million surgical procedures with overwhelming success.
However, according to reports from NBC News, between 2008 and 2018 there were over 20,000 adverse events related to the da Vinci robot reported to the Food and Drug Administration. Over 2,000 incidents recorded involved injuries, with 274 incidents resulting in fatalities.
Almost 17,000 of the reports were regarding device malfunctions, which ranged from minor glitches to more concerning occurrences such as robotic arms veering off uncontrollably, or insulation from the machine dislodging inside patients' bodies.
The FDA's investigation into the reports of issues with the robots in 2013 found the company had "concealed information from the FDA, secretly recalled defective parts, and ignored known injuries to patients in its design process of critical da Vinci instruments."
According to the Sun-Sentinel, in 2023 alone, 3,098 reports of adverse events related to the da Vinci robot were filed in the database.
Intuitive has yet to respond to outlets with further comment, but told NBC in 2018: "Our training, systems, and technologies reflect, and are informed by, our commitment to patient safety, so we offer a comprehensive, intensive training program on our technology that depends on the surgeon's capabilities — and we also strongly recommend they continue training throughout their careers.
"As with any medical device manufacturer, we are only permitted to train on our technology — we cannot, by law, train on clinical practice or the clinical application of our technology."
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