Product News and Recalls

FDA Investigating da Vinci Surgical System Robot

Bloomberg reports that the U.S. Food and Drug Administration is investigating the da Vinci Surgical System, a high-tech, robot-assisted device designed to expand the surgeon’s capabilities and offer a state-of-the-art minimally invasive option for major surgery.

The da Vinci Surgical System, designed to facilitate complex surgery using a minimally invasive approach, is controlled by a trained surgeon from a console and used to perform procedures such as heart surgeries, colorectal surgery and gynecological procedures. The machine claims to make small incisions and cause minimal bleeding, leave minimal scars and speed post-surgery recovery time.

Intuitive Surgical, Inc. – the American manufacturing company responsible for this device – issued an Urgent Medical Device Notification on May 8, 2013 to its customers warning of the potential unintended discharge of electric impulses. In fact, the FDA has received more than 200 reports since 2007 of burns, cuts and infections – including 89 deaths – after this robotic surgery. The electric impulses apparently leak through previously undetected microscopic cracks in the protective covers insulating some of the tools that da Vinci uses.

The agency notes the serious nature of these injuries and questions whether Intuitive has done enough to warn hospitals and surgeons and correct the alleged problems.

If you or a loved one experienced burns, cuts, or infections after a procedure with a da Vinci Surgical System, you should consult with a doctor if there are any ongoing symptoms or health concerns. If you have significant injuries, you should also consult with a Lopez McHugh lawyer to discuss your legal rights.