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FDA Warning Letter for Intuitive Surgical Robot Manufacturer


July 19, 2013 — Intuitive Surgical Inc., the company that sells the Da Vinci Surgical System, has received a Warning Letter from the U.S. Food and Drug Administration (FDA). The “483 Letter” cites problems discovered during inspections in April and May. Intuitive warned customers about design defects in October 2011, but failed to notify regulators until recently.

The inspectors found that Intuitive Surgical began warning their customers about issues with the robotic scissors “tip covers” in response to over 134 complaints between January 2010 and December 2011. Customers reported problems with electricity arcing from the scissors, which use an electrical current to cut and cauterize tissue.

Design defects were also noted with certain surgical instruments, which are “commonly known to need cleaning during surgery.” Surgeons reported attempting to clean the instruments by scraping them against other surgical instruments. When the electrical instruments touched, “the scraping led to tears or holes in protective tip covers that led to arcing that in turn led to injuries to patients.”

Intuitive also warned customers that the FDA has not approved the robot for procedures to remove the thyroid gland (thyroidectomy). The company received 13 complaints involving thyroidectomy procedures between July 2009 and October 2011.

The company is now facing a growing number of robot surgery lawsuits involving patients who were injured by the Da Vinci Surgical System. The company has recently warned that life-threatening injuries can occur due to micro-cracks in the EndoWrist Hot Shears Monopolar Curved Scissors, which are electrified scissors used to cut and cauterize tissue.

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