Company Fails to Notify FDA of Da Vinci Robot Correspondence

Intuitive Surgical, the manufacturer of the da Vinci robotic surgery system, recently received a warning letter from the FDA about its failure to alert the agency to communications and warnings the company sent out to select medical providers. A growing number of lawsuits allege injuries sustained from da Vinci robot surgery, and a recent, limited recall of 30 da Vinci robots was implemented voluntarily by Intuitive.

Earlier this year, Intuitive announced falling shares due partly to decreased demand for the da Vinci surgery system.

The recent letter sent from the FDA was dated July 16, 2013. In it, the agency warned Intuitive Surgical of numerous instances where the company failed to notify the FDA of correspondence sent to clients and medical providers. These actions violate federal regulations that require medical device manufacturers to notify the FDA of such correspondence within 10 days. The letter comes after an FDA inspection of one of the company’s production facilities, which took place between April 1 and May 30, 2013.

Examples of violations

The FDA letter cited instances where the company failed to properly notify the agency of such communications. The first involved correspondence regarding damaged tip covers on the device that led to some patient injuries. The second involved da Vinci robotic surgery problems during thyroid surgeries, which the device had not received clearance for. The third provided information about the proper inspecting and flushing of cannulas. All of these correspondences took place in October, 2011.

A fourth correspondence cited in the FDA letter was dated January, 2013, and involved warnings about use of the robotic surgical device on certain types of patients, particularly children. The correspondence actually contained a warning to medical providers against using the robotic device on pediatric patients. Like the other letters, this correspondence did not get sent to the FDA.

Sales and shares drop for Intuitive Surgical

Intuitive Surgical recently announced that shares fell 11% after the company was forced to slash its sales predictions for 2013.  Intuitive attributed the slowdown to a variety of factors, including decreasing demand, resistance by insurers to cover robotic procedures, and “negative press.”

The company was specifically referring to recent media reports that question the benefits and cost-effectiveness of robotic procedures. Recent studies have suggested the outcomes, complications and morbidity rates with robotic procedures are similar to traditional surgical methods, although the cost of robotic procedures can be much higher.

Da Vinci robotic surgery problems

The da Vinci system is the only robotic surgical device currently used in the U.S. However, reports of complications with the device, including surgical burns, perforated organs and other serious injuries have led some physicians and patients to question its benefits. Earlier in 2013, Bloomberg News reported robosurgery has been associated with 70 deaths since 2009.