Another day, another problem for Intuitive Surgical. Not a month’s gone by since the FDA last called the company to task for a possible failure to report problems with its da Vinci surgical robots (“FDA Warns Intuitive Surgical About Da Vinci Robot Warnings The Company Never Shared”). Now, a Class II recall for certain instruments has been announced – with reports that some of the 30 affected instruments may never have been tested properly.
Some lawsuits have questioned Intuitive Surgical’s marketing and training practices.
According to the FDA, a Class II recall follows 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 the da Vinci surgical robot’s case, the action affects Si Vision System Cart , Si Surgeon Side Cart , Instrument Control Box and the Dual Camera Controller . The recall notices, posted on the FDA’s website on July 11 note that factory testing may not be in line with current standards. This seems to follow the discovery that a testing device was working incorrectly. The affected devices, however, have since passed field tests and there have been no complaints, the company said.
Intuitive Surgical first launched the da Vinci robot in 2000. Since then the device has been used in hundreds of thousands of surgeries, but has also faced allegations that the robot has been linked to burns, lacerations, organ damage, and even deaths. Some lawsuits have questioned Intuitive Surgical’s marketing and training practices, accusing the company of an aggressive approach that encouraged hospitals to purchase the machine but left medical staff with insufficient training or knowledge. Along with dozens of lawsuits, the company’s had a troubled few months recently, with additional alerts issued in May about a potential burn risk, and an FDA-led survey of surgeons prompted by the high number of complaints (“Da Vinci Robot Complaint Numbers Prompt FDA Action”).