Intuitive Surgical Replaces Surgical Scissors That Could Develop Cracks and Cause Internal BurnsJun 7, 2013
Intuitive Surgical, maker of the da Vinci robotic surgery system, is shipping a new version of the EndoWrist surgical scissors to replace earlier models that may develop “micro-cracks” that could result in patient injury.
In May, Intuitive sent a warning to hospitals that the 8mm EndoWrist monopolar curved scissors, an accessory for the da Vinci surgical system, may develop tiny cracks that aren't visible to the naked eye, MassDevice reports. The cracks “may create a pathway for electrosurgical energy to leak into tissue during use,” potentially causing internal burns, the company’s letter said.
The company modified the EndoWrist scissors and began shipping the new ones as of May 31, according to MassDevice. “The company worked closely with its manufacturing partners to determine root cause and adjusted manufacturing processes for consistency to ensure the instrument will withstand the rigors of reprocessing,” Angela Wonson, Intuitive’s vice president for communications, said in an email to MassDevice.
While robotic surgery is becoming increasingly common in hospitals across the country—Bloomberg News reports that surgical robots were used in more than 300,000 operations last year—there are serious concerns about its safety and the adequacy of the training for surgeons. The U.S Food and Drug Administration (FDA), prompted by reports of serious injuries, complications, and deaths from robotic surgeries, has been investigating the da Vinci system. Intuitive faces more than two dozen lawsuits over injuries, complications and deaths. Court documents allege that the company’s training program is inadequate and is designed to promote the use of the robot system over traditional surgical techniques.