July 22, 2013 — In a report filed with the Securities and Exchange Commission (SEC), Intuitive Surgical Inc. is facing at least 26 robot surgery lawsuits involving the Da Vinci Surgical System. Since 2009, complications of robot surgery have been implicated in at least 70 deaths, according to reports submitted to the U.S. Food and Drug Administration (FDA).
Plaintiffs in the robot surgery lawsuits allege that they were injured or their family member died after surgery with the Da Vinci Surgical System. The lawsuits raise a variety of allegations, including failure on the part of Intuitive Surgical to train surgeons. Other lawsuits allege that the robot is inherently defective, and Intuitive has failed to warn about these risks.
The most recent lawsuit to go before a jury was filed in 2009 by the family of Fred Taylor. The lawsuit alleges that Mr. Taylor was injured by a surgeon who had never performed a robotic surgery unsupervised. His surgeon accidentally punctured his intestines and caused complications that led to his death four years later.
Another lawsuit was filed on behalf of Juan Fernandez, a man whose family was awared $7.5 million in a medical malpractice lawsuit. Mr. Fernandez died in 2007 after undergoing what should have been a straightforward spleen surgery. His surgeons had little experience with the Da Vinci Surgical System. They accidentally punctured his intestines and caused a fatal infection.
As the popularity of robotic surgery has increased, so has concern about a spike in adverse event reports. Serious complications include:
- infection
- organ damage
- blood vessel perforation
- bleeding
- bowel or ureter damage
- burns and electrocutions
- vaginal cuff dehiscence (disembowelment through re-opened incisions after a hysterectomy)
- death