A federal lawsuit filed Wednesday alleges that a Florida woman’s death resulted from a stray electrical arc emitted by a surgical robot during a colon cancer procedure.
Delray Beach resident Harvey Sultzer filed the suit in U.S. District Court in West Palm Beach, claiming that Intuitive Surgical Inc. neglected to alert his wife, Sandra Sultzer, about potential issues involved in the surgery, which could led her to opt against using the company’s da Vinci surgical robot during September 2021 procedure.
According to the lawsuit, the company also failed in designing its product to prevent stray electrical energy from causing internal burns in patients.
The lawsuit highlighted that the da Vinci robot is a multi-armed surgical device introduced in 1999, which surgeons remotely control with the assistance of an onboard camera. The robot’s instruments include forceps, scissors, scalpels, and various other surgical tools.
Intuitive reportedly sells its systems to hospitals lacking prior experience in robotic surgery and without training surgeons on the operation of the da Vinci device, the lawsuit states.
According to a 2018 investigation by NBC News, hospitals are not legally required to train surgeons on how to adequately use the device.
The suit also alleges that the company has had thousands of injuries and defects reported in connection with da Vinci, but “systematically underreported” the injuries reports to the Food and Drug Administration (FDA).
The plaintiff’s attorney declined to comment on the case, beyond what’s been stated in the lawsuit. Read the full documents below.
Da Vinci Surgical Lawsuit by Leigh Egan
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