Robot devicemaker sued over patient death

A lawsuit filed in Florida accuses Intuitive Surgical, a medical device company, of knowingly selling a surgical robot with known insulation issues that burned a woman's small intestine during an operation, NBC News reported. 

Harvey Sultzer filed the lawsuit on behalf of his wife, Sandra Sultzer, who died in February 2022 from complications from a small intestine injury. After Ms. Sultzer underwent surgery for colon cancer, she developed abdominal pain and fever in late 2021. The lawsuit accuses the devicemaker of the da Vinci Surgical System, a surgical robot, of knowing of insulation issues that can cause electricity failures and burn internal organs. 

Mr. Sultzer's lawsuit also accuses Intuitive Surgical of selling the da Vinci product to hospitals that lack experience in robotic surgery, as well as underreporting thousands of reports about the defect to the FDA. 

The lawsuit does not include a surgery date, and the most recent clinical data cited is from 2013.

A spokesperson for Intuitive Surgical said the company does not comment on ongoing litigation, but shared the following statement:

"There have been more than 14 million procedures performed using da Vinci surgical systems, and more than 38,000 scientific articles published that support the safety, effectiveness and positive clinical outcomes for patients. Depending on the procedure, those benefits can include shorter recovery times, fewer surgical complications, and less blood loss," the company said, adding that it provides training for the system.

Copyright © 2024 Becker's Healthcare. All Rights Reserved. Privacy Policy. Cookie Policy. Linking and Reprinting Policy.

 

Featured Whitepapers

Featured Webinars