The type of letter the FDA sent Intuitive is not a final determination, but it does mean that the FDA considered Intuitive in violation of regulations.
(PRWEB) June 28, 2013
The U.S. Food and Drug Administration has alleged that da Vinci surgical robot maker Intuitive Surgical warned customers before the FDA about a potentially dangerous issue with the da Vinci in 2011, breaking an established regulatory protocol. The Rottenstein Law Group LLP, a da Vinci law firm that explains da Vinci lawsuits and side effects at http://www.davincilawsuit.net, notes that this is yet another FDA announcement involving the company following a previous one in April 2013.
According to CNBC*, Intuitive notified surgeons about proper protocols for tip covers and for the correct generators to be used with those instruments. The FDA said the “correction” was in response to complaints about problems with electrical currents jumping from the equipment to patients during surgery, leading to injury. However, the article said, the company did not first warn the FDA.
“The type of letter the FDA sent Intuitive is not a final determination, but it does mean that the FDA considered Intuitive in violation of regulations,” said Rochelle Rottenstein, principal of the Rottenstein Law Group LLP. “The issue addressed—the ‘arcing’ of electricity from the surgical tools to the patient—could cause the patient internal burns, an alleged side effect that we often hear about when fielding phone calls from potential plaintiffs.”
Intuitive Surgical asserts that it is fully committed to superior training opportunities for surgeons and surgical teams in the use of its products, but notes that it does not participate in determining when a surgeon is adequately prepared to operate using the da Vinci Surgical System. According to a USA Today article, the da Vinci surgical robot was used in about 400,000 surgeries in 2012.** Recently CNBC aired a documentary about the da Vinci, focusing on the potential dangers. In May 2013 Intuitive defeated a negligent training claim in court (Estate of Fred E. Taylor v. Intuitive Surgical Inc.; 09-2-03136-5, Superior Court, Port Orchard, Wash.).
The Rottenstein Law Group LLP encourages people to visit its website to download a free brochure to help them determine if they are eligible to file a da Vinci lawsuit.
For the latest news on defective medications and medical devices and related lawsuits, visit the Rottenstein Law Group LLP’s Injury Lawyer Newswire at injurylawyernewswire.com. Readers can subscribe to the news site’s stories and videos to stay on top of personal injury news.
*cnbc.com/id/100843549 (June 25, 2013)
**usatoday.com/story/news/nation/2013/04/09/robot-surgery-fda/2067629/ (April 9, 2013)
About THE ROTTENSTEIN LAW GROUP LLP
The Rottenstein Law Group LLP is a New York-based firm that represents clients nationwide in mass tort actions. The firm was founded by Rochelle Rottenstein, who has more than two decades of experience as a lawyer, to represent clients hurt by defective medical devices and medications. (Attorney advertising. Prior results do not guarantee a similar outcome.)
The Rottenstein Law Group LLP
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