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FDA Says Da Vinci Robot Stall Issues Warranted a Class II Recall

Following Intuitive Surgical Inc.’s warning late last year that the instruments used in its da Vinci robots can stall for a brief moment during surgical procedures, the Food and Drug Administration put out a notice classifying this issue as a Class II recall. When the FDA makes this type of recall, it means that the agency believes that the product may cause health problems that are “temporary or medically reversible,” as well as more serious health issues. That said, the instruments have not actually been recalled from the market. However, inspections are taking place to see whether the devices need to be repaired or replaced.

At The Gilbert Law Group, our surgical robot claims lawyers believe that Intuitive Surgical has been very persuasive in promising that these medical devices will improve results and patient recovery, which is why over 300 hospitals in the US alone are currently using them in about 350,000 procedures a year. Our product defects law firm remains very concerned about the injuries and deaths that have occurred during robotic surgery. The New York Times reported last year that according to a study published in The Journal for Healthcare Quality, there had been at least 71 deaths and 174 injuries related to da Vinci procedures. The number of da Vinci injury lawsuits claiming products liability over this device continue to go up.

The American Association for justice writes that in 2013 alone, there were at 3,697 reports of injury, death or malfunction involving the da Vinci Robot—up significantly from the 1,595 incidents reported in 2012. (While previous underreporting may be the cause of this spike, the medical devices are used in a number of procedures.) The FDA wants doctors and hospitals to get proper, complete training before using the robots.

Intuitive Surgical put out this latest warning after three customers submitted incident reports. The problem appears to involve friction in the arms of the instrument, which can disrupt their motion. Close to 1,400 instruments are involved globally, although there are less da Vinci robots involved because some of them work with more than one instrument. The da Vinci robots let doctors perform procedures that are minimally invasive using a computer console to control the device’s different instruments.

The FDA also put out a class II recall for certain da Vinci EndoWrist needle driver lots, which guide and hold the instruments, over concerns that the jaw inserts of the driver may detach. The American Association for Justice says Intuitive Surgical has received reports of 82 incidents involving these faulty or detached inserts. In 27 of the incidents, the inserts came off during a surgical procedure. One patient had to undergo a second surgery to remove a device fragment that fell in during the first procedure.

Whether it was because a da Vinci robot was defective or surgeons were improperly trained, your injury or a loved one’s death might have been preventable. Please contact our products defects law firm to explore your legal options. Your case consultation with us is a free, no obligation case assessment.

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