A man in the United States has sued a medical manufacturer after claiming that his surgical robot burned a hole in his wife's organs while performing a procedure to treat her colon cancer, leading to her death, according to a report in the United States. New York Post. The lawsuit stated that the robot burned a hole in her small intestine, requiring additional medical interventions.
Sandra Sultzer's husband, Harvey Sultzer, filed a complaint against Intuitive Surgical on February 6, 2024, alleging that his wife was experiencing health problems as a result of surgery performed by their surgical robot. According to the lawsuit, the woman had surgery in September 2021 at Baptist Health Boca Raton Regional Hospital to treat her colon cancer with the multi-armed, remote-controlled da Vinci robot.
According to the company, the device is advertised “to enable precision beyond the limits of the human hand” because it is “designed to provide surgeons with natural dexterity while operating through small incisions”, allowing for minimally invasive procedures .
According to the lawsuit, Ms. Sultzer died in February 2022 as “a direct and proximate result of the injuries she sustained” after undergoing the surgeries.
The lawsuit states that the company knew the robot had insulation problems that could cause damage to internal organs, but this was not communicated to the family. It added that the company has received thousands of reports of injuries and defects related to the robot. However, they “underreported” them to the Food and Drug Administration.
The lawsuit also alleges that the company fails to adequately train doctors in the use of the da Vinci system and sells its robots to hospitals that are inexperienced in robotic surgery. Mr. Sultzer is suing IS for more than “$75,000 for negligence, products liability, including design defects and failure to warn, loss of consortium and damages.”
The Da Vinci system, one of the first surgical robots, was introduced by IS in 1999. After receiving FDA approval a year later, the device was accused of numerous flaws.