This is just the most recent recall involving the da Vinci Surgical System this year, and will only add to questions regarding the safety and efficacy of the device.
New York, New York (PRWEB) December 20, 2013
As da Vinci robot lawsuits (http://www.davincirobotlawsuithelp.com/) move forward in courts around the U.S., Bernstein Liebhard LLP notes that Intuitive Surgical, Inc. has issued a recall for Large Needle Driver and Mega Needle Driver Endowrist Instruments used with the da Vinci Surgical System. According to a report from MassDevice.com, the recall was announced on November 19th, and recently declared a Class II recall by the U.S. Food & Drug Administration (FDA). A Class II recall indicates that a device may cause temporary or medically reversible health problems, as well as the possibility of serious health problems.*
According to the Intuitive Surgical recall notice, certain lots of the affected Endowrist instruments, all of which were manufactured prior to October 2011, are associated with an elevated rate of detachment of a small metal piece known as the jaw insert. The company reported that the occurrence rate of jaw insert detachment is 0.01% per procedure. * According to MassDevice.com, Intuitive has received 102 complaints relating to the Endowrist instruments, one of which required a patient to undergo a second operation to retrieve a detached jaw insert.
“This is just the most recent recall involving the da Vinci Surgical System this year, and will only add to questions regarding the safety and efficacy of the device. Our Firm receives inquiries on a regular basis from patients who suffered robotic surgery complications allegedly caused by malfunctioning da Vinci instruments,” says Bernstein Liebhard LLP, a nationwide law firm representing the victims of defective drugs and medical devices. The Firm is currently offering free da Vinci lawsuit evaluations to individuals who allegedly suffered serious injuries in procedures involving the da Vinci Surgical System.
Intuitive Surgical Recalls
The Endowrist instrument recall is the third Class II recall issued by Intuitive Surgical in the past year. On December 3rd, a class II recall was announced for certain da Vinci instrument arms, due to possibility that they could stall during procedures. When this occurs, there could be a sudden "catch-up" if the surgeon attempts to push through the resistance created by the stall. According to the FDA, some 1,386 da Vinci systems worldwide could be impacted by the recall. However, Intuitive Surgical will be making repairs and replacements as needed to the affected system, rather than pulling them from the market. No injuries were associated with this recall.***
In July, the company recalled a number of instruments that it said had not been properly tested at the factory. The FDA also deemed that action a Class II recall. The products were retested in the field, and no injuries were reported.****
According to an article published by Bloomberg.com last month, the FDA has confirmed that reports of robotic surgery complications related to the da Vinci more than doubled over the past year, with the agency's database logging some 3,697 such reports through November 3, 2013. In 2012, it received just 1,595 reports of such incidents. The same report also noted that Intuitive Surgical is facing at least 50 da Vinci robot lawsuits, all filed on behalf of individuals who allegedly suffered serious injuries due to the da Vinci Surgical System.*****
Alleged victims of robotic surgery complications associated with the da Vinci Surgical System may be entitled to compensationfor their injuries. To learn more about filing a da Vinci lawsuit, please visit Bernstein Liebhard LLP's website, or the Firm's Facebook page: https://www.facebook.com/davincirobotlawsuit. To obtain a free review of your da Vinci lawsuit, please call 800-511-5092.
*massdevice.com/news/fda-intuitive-surgical-recalls-are-class-ii, MassDevice.com, December 19, 2013
**intuitivesurgical.com/company/media/statements/2013-11-19-LND-Recall-statement.html, November 19,2013
***accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=123823, FDA, December 3, 2013
****accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=119691, FDA, July 11, 2013
*****bloomberg.com/news/2013-11-08/intuitive-surgical-robot-incident-reports-double-in-year.html, Bloomberg.com, November 9, 2013
About Bernstein Liebhard LLP
Bernstein Liebhard LLP is a New York-based law firm exclusively representing injured persons in complex individual and class action lawsuits nationwide since 1993, including those who have been harmed by dangerous drugs, defective medical devices and consumer products. The firm has been named by The National Law Journal to the “Plaintiffs’ Hot List,” recognizing the top plaintiffs’ firms in the country, for the past 11 consecutive years.
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