Harvey Sultzer, the husband of a Florida woman who died after a robotic device burned her small intestine during surgery, has filed a wrongful death lawsuit against the makers of the robot. The lawsuit was filed in early February in the United States District Court for the Southern District of Florida.

Seventy-eight-year-old Sandra Sultzer underwent surgery for colon cancer in September 2021 at Baptist Health Boca Raton Regional Hospital. She was operated on using a popular surgical robot known as the da Vinci robot. After her surgery, she complained of abdominal pain and developed a fever. She underwent an additional procedure to repair a hole burned in her small intestine but would pass away in February 2022 because of the “direct and proximate result of the injuries she suffered.”

The four-armed da Vinci robot works alongside a console and camera system to conduct surgeries in a less invasive manner while offering more range of motion than traditional surgery. Surgeons use the console’s joystick and attached foot pedals to control the movements of the robot’s arms. A separate screen allows surgeons to see the movements made.

The robot arms, each of which is outfitted with surgical equipment including forceps, scalpels, and other tools, are wrapped in rubber sleeves designed to keep electricity from leaking out. The lawsuit argues that there were cracks in the rubber which caused the electrical currents to escape, burning a part of the body outside the surgery site. The jump of electricity, also known as arcing, went unnoticed by the surgeons because it was out of their field of vision.

The lawsuit is accusing da Vinci’s makers, Intuitive Surgical, of knowing that there were insulation problems with the robot’s arms that could leak out electricity and burn parts of the body that were outside of the surgery zone.

The lawsuit also says that Intuitive Surgical knowingly sells its robots to hospitals that do not have experience in robotic surgery and that surgeons are not properly trained on how to use the robotic devices. The company does have a training program, but it does not require that doctors complete it.

This is not the first time Intuitive Surgical’s robots have been at the center of controversy. In its annual 2023 report, the company shared with the SEC that it was named as a defendant in "a number of individual product liability lawsuits" that have similar claims made in Sultzer’s lawsuit.

The lawsuit also points out that the company is currently named as a defendant in “approximately 93 individual product liability lawsuits filed in various state and federal courts by plaintiffs who allege that they or a family member underwent surgical procedures that utilized the da Vinci Surgical System and sustained a variety of personal injuries and, in some cases, death as a result of such surgery.”

Schultz's lawsuit also details that between July 2009 and December 2011, the company received hundreds of complaints about its da Vinci robot. In 2011, the University of Western Ontario brought forward its own concerns after testing 37 Intuitive Surgical robots and finding that all robots had experienced “energy leakage.”

The lawsuit claims negligence and product liability, detailing that the company failed to exercise reasonable care before releasing its product into the market to unsuspecting patients. The lawsuit adds, “Had ISI safely designed its product so that stray electrical energy would not burn the insides of patients without the knowledge or control of the operating surgeons, the small intestine injury to Mrs. Sultzer would not have happened, and she would not have died.”

The complaint also accuses the company of engaging in “the business of selling, distributing,

supplying, manufacturing, marketing, and promoting the da Vinci robot and other ISI products that were defective in design and manufacture, and were unreasonably dangerous to patients.”

Intuitive Surgical has not responded to the lawsuit; however, in 2018 amid similar allegations, the company shared with NBC, “Our training, systems, and technologies reflect, and are informed by, our commitment to patient safety, so we offer a comprehensive, intensive training program on our technology that depends on the surgeon's capabilities — and we also strongly recommend they continue training throughout their careers.”