Colon cancer patient died after surgical robot burned hole in organ: lawsuit
A grieving widower has filed a lawsuit against a drug manufacturer, claiming that its device caused a hole in his wife’s organs during a colon cancer procedure, ultimately leading to her death.
Harvey Sultzer, husband of the late Sandra Sultzer, filed a lawsuit on February 6 against Intuitive Surgical (IS) claiming his wife suffered health complications after a procedure completed by a surgical robot.
Sandra underwent surgery 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 suit alleges that the device caused a hole in her small intestine, requiring Sandra to undergo additional medical interventions.
After the procedures, Sandra continued to suffer from abdominal pain and had a fever until her death in February 2022 “as a direct and proximate result of the injuries she sustained,” the lawsuit claims.
The suit alleges that ISIS knew the robot had insulation problems that could cause the device to burn internal organs — something a Food and Drug Administration (FDA) investigation between 2009 and 2011 found numerous reports of — but did not disclose that risk. The Sulzer family or the public.
It also claims that ISIS has received thousands of reports of injuries and defects associated with the surgical robot, but has “systematically under-reported” the injuries to the FDA.
According to a 2014 financial report filed by ISIS with the Securities and Exchange Commission, the company said it was a defendant in about 93 lawsuits at the time “alleging that they or a family member underwent surgeries that used the da Vinci Surgical System and “suffered a variety of personal injuries,” In some cases, he died as a result of this surgery.
Last year, the company notified the Securities and Exchange Commission that it was a defendant in “a number of individual product liability lawsuits” involving the same allegations in its annual report.
The latest lawsuit also alleges that the manufacturer sells its robots to hospitals that have no experience in robotic surgery and do not properly train surgeons on how to use the da Vinci device.
A 2018 NBC News investigation found that ISIS offers a training program, but cannot legally require surgeons to complete it.
IS introduced the first prototype of the da Vinci system in 1999 as one of the first surgical robots. The device was approved by the US Food and Drug Administration (FDA) a year later, but has since been accused of several flaws.
Harvey is suing IS for more than $75,000 for negligence, product liability, including design defect and failure to warn, loss of consortium and punitive damages.