A grieving widower is suing a medical manufacturer, alleging that its device tore a hole in his wife’s organs during a procedure to treat her colon cancer, ultimately causing her death.
Harvey Sultzer, husband of the late Sandra Sultzer, filed a lawsuit on February 6 against Intuitive Surgical (IS) alleging that his wife suffered health complications following a procedure performed by his 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 remote-controlled, multi-armed device, according to the lawsuit.
The device is advertised “to enable precision beyond the limits of the human hand,” and is “designed to provide surgeons with natural dexterity as they operate through small incisions,” allowing for minimally invasive procedures.
The lawsuit claims the device burned a hole in her small intestine, forcing Sandra to undergo additional medical interventions.
After the procedures, Sandra continued to suffer abdominal pains and fever until she died in February 2022 as a “direct and proximate result of the injuries she sustained,” the lawsuit states.
Harvey Sultzer, the husband of the late Sandra Sultzer, filed a lawsuit on February 6 against Intuitive Surgical (IS), alleging that his wife suffered health complications following a procedure performed by his surgical robot. Europa Press via Getty Images
The lawsuit alleges that IS knew the robot had insulation problems that could cause the device to burn internal organs (of which an investigation by the Food and Drug Administration (FDA) between 2009 and 2011 found numerous reports), but he did not 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 “consistently failed to report” the 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 about 93 lawsuits at the time that “alleged that they or a member of their family underwent surgical procedures that used the da Vinci Surgical System and suffered a variety of personal injuries and, in some cases, death as a result of said surgery.”
The device is advertised “to enable precision beyond the limits of the human hand,” and is “designed to provide surgeons with natural dexterity as they operate through small incisions.” AFP via Getty Images
Last year, the company told the SEC it was a defendant in “several individual product liability lawsuits” involving the same allegations in its annual report.
The recent lawsuit also alleges that the manufacturer sells its robots to hospitals that have no experience in robotic surgery and do not adequately train surgeons how to use the da Vinci device.
A 2018 NBC News investigation found that IS offers a training program but cannot legally require surgeons to complete it.
The lawsuit claims that Sandra continued to suffer abdominal pain and had a fever until she died in February 2022 as a “direct and immediate result of the injuries she sustained.” VCG via Getty Images
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 flaws.
Harvey is suing IS for more than $75,000 for negligence, product liability including design defects and failure to warn, loss of consortium and punitive damages.
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Source: vtt.edu.vn