A grieving widower is suing a medical manufacturer, claiming that its device burned a hole in his wife’s organs during a procedure to treat her colon cancer, eventually leading to her death.
Harvey Sultzer, husband of the late Sandra Sultzer, filed a lawsuit on Feb. 6 against Intuitive Surgical (IS) claiming his wife suffered health complications following a procedure completed by their surgical robot.
Sandra underwent an operation at Baptist Health Boca Raton Regional Hospital in September 2021 to treat her colon cancer using the da Vinci robot, a multi-armed, remote-controlled device, according to the lawsuit.
The device is advertised “to enable precision beyond the limits of the human hand,” being “designed to provide surgeons with natural dexterity while operating through small incisions,” allowing for minimally invasive procedures.
The lawsuit claims that the device burned a hole in her small intestine, which required Sandra to undergo additional medical interventions.
After the procedures, Sandra continued to suffer abdominal pain and had a fever until she died in February 2022 as “a direct and proximate result of the injuries she suffered,” the lawsuit claims.
The suit alleges that IS knew the robot had insulation issues that could cause the device to burn internal organs — which an investigation by the Food and Drug Administration (FDA) between 2009 and 2011 found numerous reports of — but didn’t disclose that risk to the Sultzer family or the public.
It also claims that IS has received thousands of reports about injuries and defects associated with the surgical robot but has “systematically underreported” injuries to the FDA.
According to a 2014 financial report that IS filed with the Securities and Exchange Commission, the company said it was a defendant in around 93 lawsuits at the time which “allege that they or a family member underwent surgical procedures that utilized the da Vinci Surgical System and sustained a variety of personal injuries and, in some cases, death as a result of such surgery.”
Last year, the company told the SEC that it was a defendant in “a number of individual product liability lawsuits” involving the same allegations in their annual report.
The recent lawsuit also alleges that the manufacturer sells its robots to hospitals that have no experience in robotic surgery and doesn’t properly train surgeons in how to use the da Vinci device.
A 2018 NBC News investigation found that IS does offer a training program but can’t legally require surgeons to complete it.
IS introduced the first model of the da Vinci system in 1999 as one of the first surgical robots. The device was approved by the FDA a year later but has since been accused of many faults.
Harvey is suing IS for over $75,000 for negligence, product liability, including design defect and failure to warn, loss of consortium and punitive damages.