According to the U.S. Food and Drug Administration (FDA), 30 medical devices manufactured by Intuitive Surgical may not have been properly tested. The class 2 recall affects da Vinci Si Vision System Cart, Si Surgeon Side Cart, Instrument Control Box and Dual Camera Controller. This recall is only the latest safety issue plaguing Intuitive; the company has been in the midst of litigation over its da Vinci surgical robot and whether or not it caused fatal injuries in some patients.
A class 2 recall involves “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”. In this case, the agency said that factory testing on 30 devices may not meet compliance standards. According to the agency’s notice, Intuitive sent an Urgent Device Correction notice to all affected customers on June 27th.
The da Vinci surgical robot has garnered $215 million in sales in the second quarter with over 143 units sold, according to Bloomberg. Earlier this year, the FDA began surveying surgeons about the use of these surgical robots after noticing a spike in adverse event reports, including 70 deaths.
With the da Vinci robot-assisted surgery system, a surgeon sits several feet away from a patient and uses hand and foot controls to guide robot arms. The physician peers into a high definition screen linked up to a camera to see what is being done inside the patient. There have been mounting safety concerns about the da Vinci and whether or not Intuitive pushed doctors to use before being properly trained. One such lawsuit went to trial in Washington state court, Kitsap County. The Plaintiffs in the lawsuit stated that the surgeon who performed the robot-assisted prostate removal had never previously used the system unsupervised. More than two dozen lawsuits are still pending against Intuitive over injuries allegedly caused by da Vinci, according to a May 22nd Bloomberg report.
In an inspection report issued May 30, the FDA also faulted Intuitive for failing to report measures it took to prevent patients from electrical burns.