In late June 2013, the FDA sent a “483” letter to Intuitive Surgical, the maker of the Da Vinci Robot Surgical System, alleging that the company may have violated federal regulations in October 2011 when it sent letters to medical facilities and professionals before first alerting the FDA.
Intuitive Surgical, the company that manufactures and markets the Da Vinci Robot, has recently been notified that, according to the FDA, the Da Vinci Robotic Surgery maker may have violated federal regulations when sending communications to hospitals and medical professionals. The FDA’s notification, which is technically called a “483” letter, alleges that Intuitive Surgical failed to inform the FDA that it would be sending out letters to medical facilities and professionals prior to doing so. Intuitive Surgical’s letters, which were sent in October 2011, included recommendations as to what surgeons could do to try to avoid a specific Da Vinci Robotic Surgery complication known as arcing (arcing occurs when an electrical current from the tip of a Da Vinci robotic surgical sytem is transmitted into and injures a patient during surgery).
[cnbc.com/id/100843549 June 25]
The FDA’s 483 letter alleges that, because Intuitive Surgical’s October 2011 letters contained recommendations that could constitute labeling changes for the device, the company should have first notified the FDA of its recommendations so that federal regulators could have decided whether Da Vinci robot labeling changes were needed. Although 483 letters specify potential violations of FDA regulations, they do give companies like Intuitive Surgical a chance to defend themselves before a final determination is made. [cnbc.com/id/100843549 June 25]
Wright & Schulte, LLC specializes in defending the rights of those who have sustained serious injuries after using defective products and dangerous drugs. Our skilled Da Vinci robot attorneys are experienced at successfully going up against large corporations, like Intuitive Surgical. We encourage those who believe they have sustained Da Vinci robotic surgery complications to speak with our knowledgeable lawyers by visiting yourlegalhelp.com or by calling 1-800-399-0795.
Intuitive Surgical has attempted to defend itself against the FDA’s allegations, explaining the October 2011 letters only restated FDA-approved directions already on Da Vinci robot labels. Consequently, Intuitive Surgical has contended that the letters were documented as “a non-reportable field action” with the FDA because they did necessitate a labeling change to the existing da Vinci robot labels. While the FDA is looking into Intuitive Surgical’s claims, federal regulators have yet to make a final decision regarding whether Intuitive Surgical violated FDA regulations. [cnbc.com/id/100843549] [June 25]
FDA’s Ongoing Investigation into Reports of Da Vinci Robot Complications
The debate regarding whether Intuitive Surgical violated federal regulations with its October 2011 letter is just the most recent contentious interaction the Da Vinci robot maker has had with the FDA. In fact, in addition to receiving the FDA’s 483 letter, Intuitive Surgical has been the focus of an ongoing FDA investigation regarding what has spurred a recent increase in the number of reports of Da Vinci robotic surgery complications the agency has received.
The FDA announced in March 2013 that it would be conducting this investigation into reports of Da Vinci robotic surgery complications due to the fact that, since January 2012, at least five patient deaths reportedly linked to Da Vinci robot complications have been reported to the FDA. The focus of the FDA’s ongoing investigation will be to try to determine whether the spike reported Da Vinci robotic surgery complications is “a true reflection of problems” with these devices or whether it is due to other issues, such as an increased awareness among surgeons of reporting da Vinci surgery complications. [bloomberg.com/news/2013-02-28/intuitive-surgical-robots-probed-by-u-s-in-survey-of-surgeons.html March 2013]
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