da Vinci robotic surgical device allegedly caused fatal intestinal burns, claims lawsuit

Robots have been used in surgeries since the early 1990s, with many surgeons raving about their precision and quality in the operating room. But reviews aren’t all positive. Some robots have been found to induce complications in surgery, including injuries and even deaths.^[]

In a wrongful death lawsuit filed last week, a man is suing surgical robot manufacturer Intuitive Surgical for problems with its da Vinci device, which allegedly might have been responsible for the death of his wife, Sandra Sultzer, in 2022.^[] 

What is going on with the da Vinci robot?

Over the years, there have been multiple reports about faults with the da Vinci system, including claims about electricity or energy leakage. According to NBC, a range of other safety issues related to the device had been reported, including:^[] 

• Bent and broken tips

• Failure to cut a staple line

• Misaligned arms

• Forceps’ inability to properly grip tissue

• Reports of broken fragments from the robot falling inside a patient

According to NBC, a doctor reported seeing a flame in one scenario.^[]

“It's worth noting that there may be a learning curve for surgeons who are new to robot-assisted procedures, which could affect their ability to perform surgeries safely and effectively,” says Michael Green, MD, an OB/GYN and Co-Founder of Winona, an anti-aging wellness center. “To ensure the best care for patients, doctors must undergo comprehensive

training and certification in robot-assisted procedures to ensure proficiency and safety in using the technology.”

Individual case assessments are also imperative for determining who is a good candidate for robot-assisted surgery versus a more traditional option, Dr. Green adds.

One doctor told NBC that he had about 2 hours of prep before his first use of the da Vinci. The doctor added that the correct use of the tool can increase precision in surgery compared to human hands. Additionally, it can produce less blood loss and fewer complications, he said.^[]

Timeline of robots in surgery

The FDA approved the da Vinci system in 2000. By the 2010s, hundreds of complaints had surfaced about the robot, some mentioning cracks in the tip covers, which allow electricity to slip out. In 2011, researchers from the University of Western Ontario tested 37 robots that had been flagged for safety concerns and found that they all produced this kind of energy leakage. In 2013, the FDA sent a warning letter to Intuitive, the manufacturer. The FDA warning pertained to Intuitive’s handling of complaints and failure to comply with FDA guidelines and report specific field actions.

Timeline

• 1900s: Robotic surgery begins

• 2000: FDA approves Intuitive’s da Vinci system

• 2010s: Complaints surface about cracks in the da Vinci robot’s tip covers

• 2011: Studies find that 37 da Vinci robot tip covers produce “energy leakage”

• 2013: FDA sends warning letter to Intuitive, citing failure to comply with FDA guidelines

• 2013: Intuitive recalls tip covers (by the time the FDA letter arrives)

• 2015: Medical reports show damage to a woman’s colon and burns on her uterus following a surgery involving the da Vinci. (The woman filed a suit against the company but later voluntarily withdrew it, according to NBC.)^[]

• 2018: NBC report identifies more than 20,000 adverse events associated with da Vinci, including 2,000 injuries and 274 deaths, in the last 10 years

• 2023: Husband sues Intuitive for allegedly knowing about flaws in the robot, which the suit alleges led to the death of his wife

Risks of robot-assisted surgery

Like traditional surgeries, robot-assisted surgeries can come with the risks of human error. Unlike traditional surgeries, however, they can come with additional risks of mechanical failure.

A 2016 report by the Patient Safety Network (PSNet) highlighted several machine-based risks of robot-assisted surgeries, including malfunctions of the:^[][]

• Camera

• Binocular lenses

• Robotic tower

• Robotic arms

• Instruments

PSNet also noted burn risks from electric energy sources, highlighting complications like “electric arcing.”

Electric arcing can occur when electricity leaves the robot and is misdirected to bodily tissue. This can cause sparks and burns, leading to tissue damage in the patient, according to the report.

Robotic-assisted surgeries are expensive and can be especially risky when performed by surgeons who are not adequately trained, the report notes.^[]

So why do surgeons use robots in surgery?

Among other positives,  the report states using robots in surgery can provide:

• Minimally invasive approach

• 3D imaging of the operation

• Smaller incisions

• Decreased blood loss

• Shorter hospital stays

• Quicker return to work

• Improved cosmesis

• Lower incidence of some surgical complications

• A potentially shorter learning curve for surgeons

However, benefits may only go so far. For now, researchers say that “there is little evidence demonstrating that robotic surgery provides any long-term benefits over open techniques.”