NEW YORK, Dec. 4, 2013 /PRNewswire/ -- As da Vinci robot lawsuits (http://www.davincirobotlawsuitcase.com/) continue to mount against Intuitive Surgical, Inc., (NASDAQ: ISRG) Bernstein Liebhard LLP notes that the U.S. Food & Drug Administration (FDA) has announced a Class II recall for some instruments used with the da Vinci Surgical System. According to a notice dated December 3rd, friction within certain instrument arms can cause them to stall. 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, a Class II recall indicates that a device may cause "temporary or medically reversible" health problems, as well as the remote possibility of serious health problems.
According to a report from Bloomberg.com, Intuitive has acknowledged three incidents relating to this issue, including one that resulted in an imprecise cut. However, the company maintains that no patient complications were reported.
"This latest da Vinci recall will only add to questions regarding the safety and efficacy of the device. Our Firm receives inquiries on a regular basis from victims of robotic surgery complications allegedly related to the da Vinci, and we expect that trend to continue" 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.
Da Vinci Robot Instrument Recalls
This is the second time this year that a Class II recall has been issued for da Vinci robot instruments. In July, the company recalled a number of instruments that it said had not been properly tested at the factory.
The new recall also comes at a time when Intuitive Surgical is facing a growing number of da Vinci robot lawsuits alleging serious, and in some cases fatal, injuries to patients. In its most recent 10(k) filing, the company said that some of the lawsuits blamed machine defects for patient injuries. In other cases, the lawsuits allege that inadequate surgeon training on the part of Intuitive was behind robotic surgery complications.
Over the past year, questions about the safety and efficacy of robotic surgery have continued to mount. Just last month, Bloomberg.com revealed that FDA adverse event reports relating to the da Vinci, some of which involved patient injuries and deaths, more than doubled over the past year.
Results from a small survey of physicians released by the FDA on November 8th raised questions about training procedures for the da Vinci robot. Among other things, the 11 surgeons responding to the survey suggested the da Vinci's complicated interface was difficult to master and that training methods were inconsistent.
Individuals who suffered robotic surgery complications that may be associated with the da Vinci robot could be entitled to financial compensation for their injury-related damages. To learn more, 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 potential da Vinci lawsuit, please call (888) 340-4807.
Bernstein Liebhard LLP 10 East 40th Street New York, New York 10016 (888) 340-4807
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SOURCE Bernstein Liebhard LLP