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| EndoWrist One Vessel Sealer--Courtesy of Intuitive Surgical |
Robotic surgery can improve the accuracy and reduce the invasiveness of a broad range of surgical procedures. But it's entirely dependent on flawless execution by the surgical system. Robotic surgery player Intuitive Surgical ($ISRG) has learned this the hard way with repeated regulatory issues and recalls due to system malfunction.
In order to help address the "challenges and opportunities" raised by robotic surgery, the U.S. Food and Drug Administration is planning to hold a two-day public workshop in late July on robotically assisted surgical devices.
Most recently, the FDA issued a pair of Class II recall notices for the EndoWrist One Vessel Sealer. A Class II recall is used by the agency to address a product that "may cause temporary or medically reversible adverse health consequences."
The agency said the device may "exhibit interference in the back of the instrument grips due to manufacturing variability in some jaws." This could inhibit the "sealing and transection of thin tissue bundles and small diameter vessels," the agency said.
It advises customers to inspect the device to determine if this is an issue by re-checking tissue after the seal cycle is designated as complete. If subsequent re-grasping and re-sealing attempts are not successful, the FDA recommends that "an alternative means of sealing and transecting thin vascular tissue bundles should be used."
If this issue is found to be a problem for a particular device, the customer is advised to return it to Intuitive Surgical. The alternatives offered by the agency include using another da Vinci Vessel Sealer, alternative da Vinci electrosurgical instruments, a da Vinci Harmonic instrument or hand-held laparoscopic sealing device.
The agency posted its notices on Feb. 24 for the ongoing recalls of the EndoWrist Vessel Sealer for both the da Vinci Surgical System Xi IS4000 and the da Vinci Surgical System Si IS3000. The company also sent a letter to all affected customers on Feb. 11.
"We decided to initiate a voluntary corrective action for the da Vinci Si EndoWrist One Vessel Sealer and da Vinci Xi EndoWrist Vessel Sealer after we identified the potential for a small portion of the vessel sealers to provide insufficient energy delivery when used on thin (<2 mm), vascular tissue. We have identified the cause and are implementing a solution," Intuitive Surgical responded via email after being queried on the recall.
Almost 3,300 EndoWrist Vessel Sealers are implicated under both ongoing recalls; these were distributed in the U.S. as well as in at least 20 countries in Europe and elsewhere around the world. The EndoWrist One Vessel Sealer for the Si System was cleared by FDA in January 2012.
In September, the company stopped shipping the EndoWrist Stapler 45 for the da Vinci Si Surgical System due to an instrument malfunction that led to fires at an estimated observed rate of 0.023% in the field, according to its latest quarterly SEC filing.
In 2014, Intuitive Surgical had $77 million in pre-tax charges due to product liability claims related to a 2012 market withdrawal of a Monopolar Curved Scissor (MCS) instruments that included an MCS tip cover accessory and a 2013 recall of MCS instruments.
- here are the Si IS3000 and the Xi IS4000 FDA Class II notices