Robotic device burned a woman’s small intestine during surgery, lawsuit alleges

A woman named Sandra Sultzer, undergoing surgery for colon cancer in September 2021, experienced severe complications when a robotic device, manufactured by Intuitive Surgical, burned and tore her small intestine, as per a recent wrongful death lawsuit filed in Florida. Subsequently, Sultzer developed abdominal pain and fever, leading to additional procedures to repair the tear. Unfortunately, she passed away in February 2022 due to complications arising from the small intestine injury.

Sandra’s husband, Harvey Sultzer, is pursuing legal action against Intuitive Surgical, alleging that the company was aware of insulation issues with the robot that could cause electricity leaks, resulting in internal organ burns. The lawsuit contends that Intuitive Surgical did not disclose this risk to the Sultzers or the public.

Moreover, the legal claim suggests that Intuitive Surgical sells its robots to hospitals lacking experience in robotic surgery, without adequately training surgeons in the proper use of the device, known as the da Vinci. Despite offering a training program, an NBC News investigation in 2018 revealed that the company cannot legally mandate surgeons to complete it.

The lawsuit also claims a history of issues dating back over a decade, asserting that Intuitive Surgical has received thousands of injury and defect reports associated with the da Vinci. It alleges that the company “systematically underreported” these incidents to the Food and Drug Administration (FDA).

In 2014, Intuitive reported being a defendant in approximately 93 lawsuits related to the da Vinci Surgical System, acknowledging personal injuries and, in some cases, fatalities resulting from surgeries using their technology. The company set aside substantial funds to settle product liability claims.

Despite facing legal challenges, Intuitive Surgical maintains the safety of its robotic-assisted surgery, with many doctors considering it safe. However, debates persist about its effectiveness compared to traditional surgery.

The da Vinci system was introduced in 1999, gaining FDA approval in 2000. Sultzer’s lawsuit points to hundreds of complaints and reports about the da Vinci robot between July 2009 and December 2011, highlighting issues with the rubber tip covering the metal instruments.

In 2011, safety concerns about the device’s surgical instruments were raised in a study, revealing “energy leakage” in all 37 tested instruments, enough to cause electrical burns. The FDA sent a warning letter to Intuitive in July 2013, citing failures to comply with regulations.

Despite recalling tip covers and addressing violations, adverse events linked to the da Vinci robot continued to be reported. An NBC News analysis in 2018 identified over 20,000 adverse events in the last decade, with injuries and deaths among the reported issues.

Intuitive Surgical responded to these allegations, emphasizing the device’s safety backed by scientific evidence from over 15,000 peer-reviewed publications.