The instrument in question, EndoWrist Monopolar Curved Scissors, also known as Hot Shears, could develop small, invisible cracks, or “micro cracks” and cause a leak of electricity that can burn patients, as first reported by CNBC.
Intuitive Surgical says it has received one complaint of injury, and that a subsequent analysis didn't indicate energy leakage. The company also said there is “no confirmed evidence of patient injury attributable to this issue” and it is not recalling the device. A replacement product, however, would be available in two to four weeks. The FDA has been notified.
READ MORE Da Vinci Robot LEGAL NEWS
Further, the da Vinci robot has recently come under fire regarding the cost-effectiveness of robotic surgery compared to noninvasive surgery done by hand. The da Vinci robot was used in about 400,000 surgeries in the US in 2012, according to USA Today.(For more information about the da Vinci robot, view the CNBC documentary)