FDA Warns that 30 Medical Devices by Intuitive, including da Vinci, May not have been Tested

The U.S. Food and Drug Administration (FDA) announced on its website today that 30 medical devices, including the da Vinci Si Vision System Cart, Si Surgeon Side Cart, Instrument Control Box and Dual Camera Controller, have not have been properly tested by manufacturer Intuitive Surgical. The company is already facing litigation over injuries allegedly caused by its da Vinci surgical robot.

The issue the FDA has with the devices, Bloomberg reports, is that factory testing may not meet compliance standards. As a result, the agency has issued a class 2 recall for the products. The class 2 recall means that the devices pose “a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote”.  Intuitive sent an Urgent Device Correction notice to all affected customers on June 27^th, the FDA said.

Earlier this year, the FDA began surveying surgeons about the use of the da Vinci surgical robot. This survey was done in response to an increasing number of adverse injury reports, including 70 deaths.

In the second quarter alone, the da Vinci reaped $215 million in sales with more than 143 units sold, according to Bloomberg. The system involves a video-game like set up where the surgeon sits several feet away from the patient and looks into a high definition screen to view what is being done. Hand controls and foot pedals are used to guide mechanical arms during surgery. The da Vinci, which is currently the only type of robot-assisted surgery in the US, has allegedly caused injuries such as burns and cut blood vessels. At least two dozen lawsuits are pending in court, some of which allege that the system caused fatal complications. The first of these cases went to trial in Washington state court, Kitsap County.

Among other things, Plaintiffs in the lawsuits against Intuitive allege that the company failed to properly trained surgeons. During the first trial, Plaintiffs’ attorneys presented evidence suggesting that Intuitive actually encouraged surgeons to use the system before an adequate number of supervised surgeries.

In an inspection report issued May 30, the FDA faulted Intuitive for failing to report measures it took to prevent patients from electrical burns. Other health professional groups and regulatory-type agencies have also taken issue with the system. In March, the president of the American Congress of Obstetricians and Gynecologists warned consumers that there is little evidence showing that robot surgery is the best option for minimally invasive hysterectomy. Shortly afterwards the Massachusetts Board of Registration in Medicine warned about complications linked to the da Vinci, including bleeding, adhesions, damage to the bowel and ureter, and one case where a piece of rectal tissue was left inside the patient.