A tragic incident occurred during a surgery for colon cancer in the US, where a robotic device allegedly caused severe harm to a woman’s small intestines, leading to a wrongful death lawsuit filed in Florida. Sandra Sultzer, experienced abdominal pain and fever post her September 2021 surgery, due to which she required additional procedures to address the tear caused by the robotic device. She passed away in February 2022 after she suffered burns and tears during surgery. The lawsuit, filed by her husband Harvey Sultzer against the device maker, Intuitive Surgical, claims that the company was aware of issues in the robot, which could lead to internal organ burns, but failed to disclose this risk. The lawsuit further claims that proper training wasn’t provided to surgeons about using the Da Vinci device and it was sold to hospitals without proper robotic surgery experience.
According to the New York Post, the company marketed surgical systems for its precision and other capabilities is facing scrutiny for underreporting injuries to the Food and Drug Administration (FDA). The device has allegedly caused severe harm to thousands of other patients. Reportedly, the company has faced approximately 93 lawsuits, each claiming personal injuries and in some cases, deaths were also reported.
As reported by NBC, Jack Scarola, the attorney representing Harvey Sultzer, refrained from providing additional information about the allegations. However, he claimed that safety concerns surrounding the da Vinci are not new. The lawsuit claims that the company has received numerous complaints about the robot device between July 2009 and December 2011. Many of these reports highlighted issues such as cracks or slits on the rubber tip covering the machine’s metal instruments.
In 2011, a study conducted by researchers from the University of Western Ontario raised alarms about the ‘energy leakage’ in all 37 tested instruments. The leakage was considered strong enough to cause electrical burns. Later, in July 2013, the FDA issued a warning letter to Intuitive Surgical, for not following the regulations.
The FDA letter stated, “Though the field action was undertaken to reduce a risk to health posed by the device, you failed to report the field action to the FDA as required.”
Over the past decade, the da Vinci device has been associated with over 20,000 cases, as reported by NBC. While the majority of these cases involved malfunctions, including some minor incidents, 2,000 reports were about injuries and 274 were linked to deaths.
Comments
0 comment