A New Jersey woman has filed a lawsuit against Intuitive Surgical, maker of the da Vinci surgical robot system, alleging pain and bowel injury from robot-assisted surgery.
The plaintiff, Sheena Wilson, alleges Intuitive Surgical knew that electrical current from one of the robot’s arms can “jump” from the tip of the device into the patient, possibly causing serious injury, and Intuitive failed to adequately warn surgeons and hospitals in a timely manner, according to the Newark Star-Ledger.
An Intuitive Surgical spokeswoman declined comment on this specific case but did stand by the company’s overall safety record, the Star-Ledger reports. “As with any surgery,” Angela Wonson said, “da Vinci Surgery is not without risk. The da Vinci Surgical System is an advanced tool and is not a substitute for the training, experience and surgical judgment of the surgeon with respect to how a particular surgery should be performed.”
Intuitive faces more than two dozen other lawsuits from patients. Their complaints describe injuries and complications including sepsis, severe bowel injuries, and punctured blood vessels, organs, or arteries.
A report by the U.S. Food and Drug Administration (FDA) said Intuitive was allegedly not clear enough in instructions to surgeons about how to clean tools during surgery. Surgeons were scraping instruments against each other, which, the FDA said, “led to tears or holes in protective tip covers that led to arcing that in turn led to injuries to patients,” according to the Star-Ledger.
Some lawsuits allege that Intuitive does not offer adequate training to surgeons before they perform robot-assisted surgeries on their own. The training process has been shortened from the one outlined in documents submitted to the FDA for the system’s approval. Court documents allege that the company’s training program is inadequate and is designed to promote the use of the robot system over traditional surgical techniques, according to Bloomberg News.