Intuitive May Have Violated Federal Law By Failing to Alert Regulators of Robotic Surgery Complications, FDA Reports
A recent notice from the U.S. Food and Drug Administration (FDA) states that Intuitive Surgical may have violated federal law by failing to first alert regulators when it warned customers about potential robotic surgery complications that may result from use of its da Vinci Surgical System.
According to a letter issued by the FDA on May 30th, Intuitive received a total of 134 complaints and 83 medical device reports associated with use of the da Vinci robot from January 2010 until December 2011. The company sent a letter to customers in October 2011 following these reports, offering suggestions in how to properly use the device. According to a June 25th report from CNBC.com, the FDA said Intuitive wrote to its customers in response to complaints that involved “arcing through damaged tip covers that caused patient injury.”
In a statement to CNBC.com included in the article, Intuitive said the customer letter referenced by the FDA “was a reiteration of existing FDA-cleared labeling that reminded users on proper use. Over the last several years, we have maintained consistent and ongoing communication with the FDA to include tip cover.”
26 Da Vinci Robotic Surgery Complications Lawsuits Filed as of April 2013
Last month, it was reported that Intuitive Surgical issued an “urgent medical device notification” regarding the safety of the da Vinci Surgical System’s monopolar curved surgical scissors. The instrument had the potential to develop “micro-cracks” that may not be visible to the user, CNBC.com reported on May 10th, 2013. Later that month, an article from MassDevice.com confirmed that the company modified the 8mm EndoWrist monoplar curved scissors and had begun shipping the new version as of May 31.
Meanwhile, a growing number of da Vinci robot lawsuits are currently pending in courts throughout the U.S. According to a regulatory filing with the U.S. Securities and Exchange Commission issued by Intuitive on April 19th, 26 lawsuits alleging surgical burns, cut ureters, tears to arteries and other robotic surgery complications had named the company as defendant.
The da Vinci Surgical System was approved in 2000 to aid in minimally-invasive laparoscopic, urologic and gynecologic surgeries. The device is now also used to perform gall bladder removal, gastric bypass surgery and thyroid cancer procedures.
File a Lawsuit Alleging Robotic Surgery Complications
For more information about how to file a da Vinci lawsuit alleging surgical burns, cut ureters, bowel injuries and other injuries, contact a lawyer at Bernstein Liebhard LLP. You may be eligible to receive compensation for medical expenses, lost wages, pain and suffering and other damages. Call the Firm directly at (877) 779-1414.