A Florida man whose wife died after undergoing colon cancer surgery using a multi-armed, remote-controlled robotic device is suing the manufacturer, alleging that the California-based company designed and marketed a defective and dangerous product.
Harvey Sultzer filed the federal lawsuit against Intuitive Surgical Inc. on Feb. 6 in the Southern District of Florida. The complaint alleges that Sultzer’s wife, Sandra Sultzer, endured complications and later died after injuries she sustained after undergoing surgery in September 2021 at Boca Raton Regional Hospital.
“Mr. Sultzer experienced thermal injury to the small intestine, resulting in a perforation,” the lawsuit states. “Mrs. Sultzer continued to have abdominal pain and fever after the … surgery, and additional surgeries were required to close the perforation.”
The physician doing the surgery was assisted by the da Vinci robot, the $1.47 million device manufactured by Intuitive Surgical that includes several arms and works with instruments, such as forceps, scissors and scalpels, to cut and cauterize body tissue, according to the complaint.
The medical instruments contained plastic sleeves that were susceptible to cracks, raising the risk of electricity escaping and injuring tissue, the lawsuit says.
“Had ISI (Intuitive Surgical) 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,” the complaint states. “Had ISI adequately warned about the problems with its monopolar scissors, the injuries Mrs. Sultzer sustained would not have happened, and she would not have died.”
The lawsuit alleges claims including negligence, design defects and failure to issue warnings and seeks compensatory damages, punitive damages and attorney fees. The plaintiff is asking for a jury trial.
In a statement provided to the Florida Record, Intuitive Surgical stood by the robotic device, the level of training the company provides to doctors and the device’s safety record.
“Importantly, Intuitive, by regulation, provides technology training for surgeons for the da Vinci surgical system, not instruction on the practice of medicine,” the statement says. “Intuitive’s training focuses on proficiency with our tools, and Intuitive does not – in fact, cannot – credential surgeons to perform surgery.”
The company emphasized that patient safety was its top priority, and it expressed sympathies to patients and their families who experienced complications from any medical procedure.
“There have been more than 14 million procedures performed using da Vinci surgical systems, and more than 38,000 scientific articles published that support the safety, effectiveness and positive clinical outcomes for patients,” Intuitive Surgical’s statement says. “Depending on the procedure, those benefits can include shorter recovery times, fewer surgical complications and less blood loss.”
The lawsuit, however, argues that scientific literature indicates the da Vinci robot was more expensive, did not offer outcomes that were better than traditional surgical methods and required complex physician-training sessions. In addition, the company has been a defendant in “approximately 93” product-liability lawsuits involving the da Vinci machine, according to the Securities and Exchange Commission.
Intuitive Surgical continues to defend its doctor training.
“Surgeons receive extensive training on our systems,” the company’s statement says. “More than 66,000 surgeons globally have trained through Intuitive programs, and surgical residency and fellowship institutions around the world teach surgeons when and how to use these minimally invasive tools.”