Da Vinci Surgical Robot Update: FDA Issues Class 2 Recall of Intuitive Surgical’s da Vinci Robot due to Possibly Inadequate Testing of 30 Units, Notes Parker Waichman LLP
New York, NY (PRWEB) July 15, 2013 -- Parker Waichman LLP, a national law firm dedicated to protecting the rights of victims injured by defective medical devices, notes that, according to the U.S. Food and Drug Administration (FDA), Intuitive Surgical sent Urgent Device Correction notices to all affected customers on June 27 regarding the fact that 30 da Vinci surgical robots may not have been properly tested. Calling it a class 2 recall, the FDA issued a July 11 statement on its website noting that the affected parts are the da Vinci Si Vision System Cart, Si Surgeon Side Cart, Instrument Control Box and Dual Camera Controller.
The FDA added that factory testing on those four components "may not be in compliance with UL Standards” because one of the testing devices was malfunctioning.
“As the FDA noted, it is critical for medical device manufacturers to ensure they are compliant with all applicable regulations,” said William J. Dubanevich, attorney at Parker Waichman LLP. “What is of concern here is whether or not the potential failure to properly inspect the 30 subject surgical robots could have exposed surgical patients to an increased risk of surgical complication.”
Aggressive marketing by Intuitive and whether the company is providing adequate training are among other issues related to the da Vinci, the only surgical robot approved in the U.S. for soft-tissue surgery.
On March 14th, the American Congress of Obstetricians and Gynecologists (ACOG) issued a statement warning consumers not to let aggressive marketing overshadow the risks of robot-assisted surgery. According to the news release, there is no good evidence to show that procedures with the da Vinci surgical robot are even as good as less invasive, far cheaper alternatives. ACOG, a group that represents 56,000 physicians, is not the only organization to express concerns about the safety and efficacy of robot-assisted surgery.
Also in March, the Massachusetts Board of Registration in Medicine has also highlighted the potential for serious complications in an advisory. The advisory stated that, in light of growing reports of injuries associated with the da Vinci, there should be more oversight for surgeons, and patients should be better informed about the risks. The Board cited examples of patients who had suffered bleeding, adhesions and damage to the bowel and ureter; in one case, a piece of rectal tissue was mistakenly left inside a patient’s abdomen.
Parker Waichman LLP continues to offer free legal consultations to alleged victims of da Vinci surgical robot injuries. If you or a loved one experienced surgical burns, perforated or torn organs, torn blood vessels or other injuries that could be associated with the da Vinci surgical robot, please contact their office by visiting the firm's da Vinci Surgical Robot Lawsuit page at yourlawyer.com. Free case evaluations are also available by calling 1 800 LAW INFO (1-800-529-4636).
Contact:
Parker Waichman LLP
Gary Falkowitz, Managing Attorney
(800) LAW-INFO
(800) 529-4636
http://www.yourlawyer.com
Gary Falkowitz, Parker Waichman LLP, http://www.yourlawyer.com, 1-800-529-4636, [email protected]
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