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TAMPA, Fla. (WFLA) — A Florida man filed a federal wrongful death lawsuit claiming his wife died following a da Vinci surgical robot procedure.
Harvey Sultzer, the husband of late Sandra Sultzer, filed a lawsuit on Feb. 6 and claimed his wife suffered health complications following her procedure.
According to the suit, Sandra underwent an operation at Baptist Health Boca Raton Regional Hospital in September 2021 to treat her colon cancer. The da Vinci robot, a multi-armed, remote-controlled device, was used for the surgery. The electrosurgical instruments are manufactured by ISI, which has 3,174 robots around the globe.
According to the University of South Florida Health, the surgical system that replicates a surgeon’s hand movements in real time and is called “EndoWrist.” Sultzer used this system to undergo her procedure to treat her cancer.
The lawsuit said Sandra suffered a thermal injury to her small intestine, which led to perforation and required additional medical intervention. She continued to suffer abdominal pain and had a fever. Sandra had to undergo more procedures due to the injury, and died in February 2022 as “a direct and proximate result of the injuries she suffered,” the lawsuit claims.
During an investigation by the FDA between 2009 and 2011, numerous reports claimed a small rubber sleeve on the end of the metal instrument for insulating the da Vinci device had cracks that would allow the electricity to escape, causing internal burns.
According to the suit, Sandra was not made aware of the risks that came with the surgical instrument being used, which had higher complication rates than surgery with a traditional laparoscopic instrument and made her more prone to burning.
According to the lawsuit, ISI has been hit with approximately 93 product liability lawsuits alleging that patients who underwent procedures suffered an injury and in some cases, death. There are also thousands of injury and defect reports related to the surgery, the lawsuit claims.
The manufacturer is being sued for over $75,000 for negligence, product liability, including design defect and failure to warn, loss of consortium, and punitive damages.