Da Vinci Robot Lawsuit Update: FDA Calls for Company Inspection of 110,000 Components
On the heels of another Class II recall issued in December, a second component to a surgery robot named in numerous da Vinci lawsuit filings has been flagged for potential complications by the U.S. Food and Drug Administration (FDA), according to recent reports.
According to a December 16 announcement, the da Vinci Surgical System’s EndoWrist instrument may detach during surgery. The Class II recall was issued as a preventative measure to call attention to the issue. On December 3, regulators similarly ordered that Intuitive Surgical inspect the robot’s Patient Side Manipulator component for possible repair and replacement after it was found to stall during surgery. This component was involved in an “urgent medical device recall” issued on Nov. 11. This action was also declared a Class II recall by the FDA.
Class II recalls involve “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,” the FDA said.
Will Patient Complications Lead to Da Vinci Lawsuit Claims?
Between the two Class II recalls issued in December, some 110,000 robotic components have been affected, according to a recent report from MassDevice.com. This news follows a letter Intuitive sent to its customers on November 15th alerting them of the problem with the EndoWrist instruments. In its notice though, the company said the problem related to a device that was manufactured prior to October 2011, and for the most part is not currently in use. Intuitive also said in a statement issued Nov. 19 that “in most cases, a surgeon would immediately notice if detachment occurred during surgery.” However, the MassDevice report did note one instance where a patient underwent a second operation to retrieve a detached component.
The da Vinci Surgical System, which has been on the market since 2000, is used to aid in minimally-invasive laparoscopic, urologic and gynecologic procedures. In recent years, an increasing amount of hysterectomies, prostatectomies and thyroid surgeries have also been performed using the device. Over the past couple of months, however, the FDA has kept a close eye on the surgery robot and its manufacturer. The agency released the findings of a survey in November that included a number of surgeons who each had experience with the da Vinci. Here’s what they found: patients may experience temporary nerve damage in the fingers, as well as reversible limb palsy, bleeding from perforated bowels, and other complications. Additionally, surgeon training may play a role in whether patient complications are experienced.
Contact an Attorney to File a da Vinci Robot Lawsuit
Call our Firm today to find out more about da Vinci robot lawsuits, and whether you may be eligible to file a claim. Contact us directly at (877) 779-1414.