Wrongful Death Lawsuit Filed Against Intuitive Surgical Over Robotic Surgery Complications

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ICARO Media Group
News
09/02/2024 23h35

In a recent development, a wrongful death lawsuit has been filed in Florida against Intuitive Surgical, the maker of the da Vinci robotic surgical system. The lawsuit alleges that a woman named Sandra Sultzer suffered severe injuries to her small intestine during a surgery for colon cancer, ultimately leading to her death.

According to the lawsuit, Sultzer experienced abdominal pain and fever following her surgery in September 2021. She required additional procedures to repair the tear in her small intestine, but sadly passed away in February 2022 as a result of the injury. Harvey Sultzer, her husband, is seeking damages and holding Intuitive Surgical responsible for the tragic outcome.

The lawsuit claims that Intuitive Surgical was aware of insulation problems in their robotic device that could cause electricity to leak out and burn internal organs, but failed to disclose this risk to the Sultzers or the public. Additionally, the suit alleges that Intuitive Surgical sells its robots to hospitals lacking experience in robotic surgery and inadequately trains surgeons in the proper use of the da Vinci system.

While Intuitive Surgical offers a training program, a 2018 NBC News investigation revealed that the company cannot legally enforce surgeons to complete it. The lawsuit further accuses Intuitive Surgical of underreporting injuries associated with the da Vinci system to the Food and Drug Administration (FDA), despite allegedly receiving thousands of injury and defect reports.

This is not the first time Intuitive Surgical has faced legal action concerning the da Vinci device. In a 2017 case involving a hysterectomy, the company denied the claim and settled for an undisclosed amount. In a 2013 case, a jury ruled in favor of Intuitive Surgical, dismissing allegations of insufficient doctor training.

Critics of robotic surgery argue that despite its touted safety benefits and precision, there is ongoing debate regarding its efficacy compared to traditional surgery. Proponents claim that robotic surgery can lead to shorter and less painful recoveries by facilitating less invasive procedures.

The da Vinci surgical system was introduced by Intuitive Surgical in 1999 and received FDA approval in 2000. However, Sultzer's lawsuit highlights that the company received numerous complaints about the device between July 2009 and December 2011, specifically relating to cracks and slits on rubber tips used to cover the robot's metal instruments. These defects allegedly allowed electricity to escape unnoticed, leading to potential burns.

Safety concerns regarding the da Vinci system's surgical instruments were also raised in a 2011 study by researchers from the University of Western Ontario, who found evidence of energy leakage in all 37 tested instruments. In response to several violations, the FDA sent a warning letter to Intuitive Surgical in July 2013.

An NBC News analysis in 2018 discovered over 20,000 adverse events associated with the da Vinci system, with more than 2,000 reports citing injuries and 274 cases involving deaths. Several patients interviewed by NBC News in 2018 claimed they were burned or injured during procedures involving the robotic device.

Intuitive Surgical responded to the allegations by stating that the safety and efficacy of their robotic-assisted surgery were supported by scientific evidence found in over 15,000 peer-reviewed publications. However, the lawsuit raises questions about the company's reporting practices and responsibility in ensuring the safety of patients undergoing surgery with the da Vinci system.

As the lawsuit progresses, the focus remains on determining the truth behind the allegations and holding Intuitive Surgical accountable for the alleged failures associated with their robotic surgical system.

The views expressed in this article do not reflect the opinion of ICARO, or any of its affiliates.

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