Woman died after robot burnt hole in organs, says lawsuit
A tragic incident in Florida, US has led to a lawsuit against Intuitive Surgical Inc., the company behind the Da Vinci surgical robot. A man named Harvey Sultzer filed the suit after his wife, Sandra Sultzer, passed away due to complications. It happened following a colon cancer operation involving the robot, at Baptist Health Boca Raton Regional Hospital in September 2021. WFLA-TV reports that during the procedure, the surgical robot accidentally burned a hole in Sandra's small intestine.
Complications and death following robot-assisted surgery
Sandra faced multiple complications and underwent additional surgeries before her death in February 2022, at the age of 78. The lawsuit alleges that her passing was a "direct and proximate result of the injuries she suffered," as stated by WFLA-TV. Intuitive Surgical has faced probes from the Federal Drug Administration (FDA) in the past, for injuries related to its surgical robot during operations.
Previous FDA investigation and concerns
The FDA investigated previous cases where the Da Vinci robot caused internal burns due to cracks in a "small rubber sleeve" on a metallic part, allowing electricity to escape. The lawsuit claims that Sandra was not informed about the increased risk of complications during robot-assisted surgeries, compared to traditional laparoscopic procedures. This made her more susceptible to burns. While surgical robots offer potential benefits like precision and minimally invasive surgery, they can also malfunction for various reasons.
What else did the lawsuit say?
The lawsuit claimed that Intuitive sells its Da Vinci robots to hospitals with no prior experience in robotic surgery. Also, surgeons are not properly trained on how to use the device. Intuitive has a training program, but surgeons are not legally required to complete it. In 2018, NBC News found over 20,000 adverse cases related to Da Vinci in the last 10 years. Most of the reports pertained to malfunctions. However, 2,000 reports claimed injuries, and 274 involved deaths.
Da Vinci has a troubled history
In a 2014 financial report filed with the SEC, Intuitive announced at the time, that it was a defendant in roughly 93 lawsuits. The plaintiffs in those cases alleged 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." The company added that it had set aside millions of dollars to settle the product liability claims.