July 19, 2013 — The U.S. Food and Drug Administration (FDA) has sent a warning letter to Intuitive Surgical, Inc., the manufacturer of the Da Vinci Surgical System. In what is known as a “483” Warning Letter. During inspections in April and May, the FDA found that Intuitive broke procedures when they warned customers about a design defect before notifying regulators.
According to the FDA, Intuitive Surgical began warning about problems with “tip covers” on the robotic scissors in October 2011. The company sent letters to customers in response to complaints about electricity arcing from the monopolar scissors (also known as “Hot Shears”), which are used to cut and cauterize tissue. Between January 2010 and December 2011, Intuitive received 134 complaints related to tip cover issues.
The FDA also found evidence of a design defect. Certain surgical instruments are “commonly known to need cleaning during surgery,” and Intuitive received reports of surgeons who were cleaning instruments by scraping them across other surgical instruments. In some cases, “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 that surgical robots are not approved for thyroidectomy, a surgery that removes all or part of the thyroid gland, which is located in the lower-front and center of the neck. From July 2009 until October 2011, Intuitive received 13 complaints related to thyroidectomies performed with the da Vinci robot.
Problems with micro-cracks in the insulation on the EndoWrist Hot Shears Monopolar Curved Scissors can lead to electrical energy arcing during surgery that can burn tissues outside the surgical area, causing patient injuries. The scissors are used in hysterectomies, prostatectomies, and more. Despite serious safety concerns, the company did not issue a recall.