Intuitive Notifies Customers of Potential Problems With Robot Named in Da Vinci Lawsuit Filings, FDA Issues Class 2 Recall of 30 Devices
Not for the first time, the company facing a rising number of da Vinci lawsuit filings has alerted customers of potential problems associated with its da Vinci Surgical System, Bloomberg.com reports.
According to an article dated July 12th, Intuitive Surgical sent an Urgent Device Correction notice to customers on June 27th after regulators found that factory testing for 30 its devices may not have met compliance standards with the U.S. Food and Drug Administration (FDA). Intuitive’s potentially improper testing of its products prompted the agency to announce a “class 2 recall’ of the Intuitive’s da Vinci Si Vision System Cart, Si Surgeon Side Cart, Instrument Control Box and Dual Camera Controller.
Earlier in the month, Intuitive’s second-quarter earnings for 2013 indicated that 143 da Vinci Surgical Systems had been sold, earning the manufacturer $215 million in sales.
“We discovered that one piece of testing equipment wasn’t recording results properly,” an Intuitive spokeswoman said in a statement told to Bloomberg News. She also noted that the 30 systems affected by the recall had been re-tested in the field, and that no complaints had been reported. “All systems have passed,” the company official added.
Robotic Surgery Complications Named in da Vinci Robot Lawsuit Filings
Intuitive must now turn its attention to the growing litigation of lawsuits alleging robotic surgery complications from its da Vinci Surgical System. These claims have been filed by patients who underwent a procedure aided by the device, which was used in over 400,000 gynecologic, urologic, laparoscopic and other types of surgeries in 2012. Claims filed in courts throughout the U.S. allege cut ureters, tears to arteries and other vital organs and even death stemming from the surgery robot.
What’s more, the number of robotic surgery complication reports filed with the FDA may be on the rise as well. According to a report aired by NBC News on June 14th, the da Vinci Surgical System has been tied to 89 deaths, and named in 200 complaints since 2007.
Were You Injured by the da Vinci Surgical System? File a da Vinci Robot Lawsuit
Patients injured as a result of undergoing a procedure aided by the da Vinci Surgical System would be wise to seek the aid of a lawyer today to start the process of filing a claim against the manufacturer. Contact an attorney at Bernstein Liebhard LLP to find out more about da Vinci lawsuits at (877) 779-1414.