By Aria Bendix -
NBC News
A robotic device burned and tore a woman's small intestine while she was undergoing colon cancer surgery, according to a wrongful death lawsuit filed this week in Florida.
The woman, Sandra Sultzer, developed abdominal pain and fever after her surgery in September 2021 and needed additional procedures to close the tear, according to the lawsuit.
Sultzer died in February 2022
from the small intestine injury, the document stated.
Her husband, Harvey Sultzer, is suing the device's manufacturer, Intuitive Surgical, for damages.
An example of the da Vinci robot during surgery. Courtesy Intuitive
The lawsuit alleges that Intuitive Surgical knew the robot had insulation problems that could cause electricity to leak and burn internal organs, but failed to communicate that risk to the Sultzers or the public.
It also claims that Intuitive sells its robots to hospitals that have no experience in robotic surgery and does not adequately train surgeons in using the device, known as a da Vinci.
Intuitive does offer a training program, but a 2018 NBC News investigation found that it cannot legally require surgeons to complete it.
Intuitive Surgical did not respond to a request for comment.
Jack Scarola, a Florida attorney representing Harvey Sultzer, said neither he nor his client had any comment beyond the allegations in the lawsuit.
Issues of this nature
date back more than a decade
, according to the lawsuit.
The lawsuit alleges that Intuitive has received thousands of reports about injuries and defects associated with the da Vinci robot, but has "systematically underreported" injuries to the Food and Drug Administration (FDA).
The da Vinci Xi.Courtesy Intuitive Surgical System
A 2014 financial report that Intuitive filed with the Securities and Exchange Commission indicated that the company was currently a defendant in about 93 lawsuits.
The plaintiffs "alleged that they or a member of their family underwent surgical procedures using the da Vinci Surgical System and suffered a variety of personal injuries and, in some cases, death as a result of such surgery," he wrote. the company.
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The company added that it also set aside $67.4 million in the first quarter of 2014 and $9.6 million in the second quarter
to resolve a series of
product liability lawsuits.
One case that went to trial in 2017 involved the use of the da Vinci robot during a woman's hysterectomy.
Intuitive claimed the lawsuit was meritless, and was settled for an undisclosed amount.
A jury previously ruled in favor of Intuitive in a case in 2013 alleging that the company had not provided sufficient training to doctors.
In its 2023 annual report, the company assured the SEC that it was a defendant in "a series of individual product liability lawsuits" related to the same allegations.
Many doctors consider robotic surgery to be safe, but there is debate about whether it is more effective than traditional surgery.
The technology aims to make procedures more precise and less invasive, which would theoretically lead to shorter and less painful recoveries.
Intuitive
introduced the first version of the da Vinci system in 1999
, when robotic surgery was still relatively new.
The FDA approved the system a year later.
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According to Sultzer's lawsuit, Intuitive received hundreds of complaints and reports about its da Vinci robot between July 2009 and December 2011. Many of the reports cited cracks or indentations in a rubber tip used to cover da Vinci's metal instruments, according to the lawsuit, adding that the defects allowed electricity to escape without the surgeons knowing.
In 2011, researchers at the University of Western Ontario noted
safety issues with the device's surgical instruments
in a study .
Researchers tested 37 instruments and found that all had "energy leaks," which in some cases they determined were enough to cause electrical burns.
Subsequently, in July 2013, the FDA sent a warning letter to Intuitive, citing several examples of its failure to comply with federal regulations.
One of them was the company sending letters to customers about how to use its tip covers, in response to patient complaints and injury reports.
"Although the field action was taken to reduce a health risk posed by the device, [the company] did not report the field action to the FDA as required," the FDA letter stated.
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When the letter was sent, Intuitive had already removed the tip covers.
A subsequent letter from the FDA in 2014 stated that Intuitive had addressed the violations cited in the warning.
But since then other adverse events associated with the da Vinci robot have been reported.
An NBC News analysis in 2018 identified more than 20,000 adverse events involving the da Vinci system over the past 10 years, according to reports submitted to the FDA's MAUDE database, which tracks problems with medical devices.
Most of the reports were related to malfunctions, some of which were minor.
However, 2,000 of them referred to injuries and
274 to deaths
.
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In total, more than a dozen patients told NBC News in 2018 that they suffered burns or injuries during procedures involving the da Vinci system.
One woman's medical records showed that her colon was damaged and her uterus was burned during a hysterectomy in 2015 that involved the robot.
Intuitive responded to the allegations at the time, stating that
the device's safety was backed
by scientific evidence.
"Although any surgery, regardless of modality, carries risks, the best evidence of the safety and effectiveness of robotic-assisted surgery can be found in the more than 15,000 peer-reviewed scientific publications that are fully based on a scientific method and that , together, support the security and effectiveness of our systems," he said.