Intuitive Surgical has begun shipping out replacement surgical scissors for their da Vinci Surgical System, known as “Hot Shears”, after the company issued a warning last month about a risk of problems with a prior version of the parts, which could develop micro-cracks that posed a risk for surgical burns and other internal injuries.
The new surgical scissors will replace the EndoWrist 8mm monopolar curved scissors, which contained a defect that could allow electricity to leak during use due to microcracks.
According to a report by MassDevice.com, the replacement scissors began shipping out on May 31.
The replacement parts became available about three weeks after Intuitive Surgical sent an “Urgent Medical Device Notification” (PDF) letter to customers on May 8, warning about the risk of surgical burns during da Vinci robotic surgery.
At that time, Intuitive Surgical warned that certain EndoWrist 8mm monopolar curved scissors may be prone to develop micro-cracks that can “create a pathway for electrosurgical energy to leak to tissue during use and potentially case thermal injury.”
Although some critics suggested that a recall for the da Vinci robot parts should have been issued, Intuitive Surgical decided not to remove the product from the field, indicating that the risks associated with cancelled or postponed surgeries until replacement parts became available would outweigh the risks of allowing the original parts to be used.
da Vinci Robot Problems
The da Vinci Surgical System is a complex robot that has been heavily marketed and increasingly used in recent years for a number of surgical procedures to provide a less invasive surgery, which reduces recovery time. The device is controlled by a surgeon looking at a virtual reality representation of the patient’s internal organs and manipulating its four metal arms with hand and foot controls.
Since it was introduced in 2000, use of the da Vinci robot-assisted surgical system has increased dramatically throughout the United States amid aggressive marketing and promotions by the manufacturer, Intuitive Surgical. However, concerns have also emerged about the risk internal injuries and death, leading the FDA to launch a probe earlier this year into the safety of the da Vinci surgical robot.
Intuitive Surgical faces dozens of lawsuits filed by patients who allege that they suffered da Vinci surgery burns or other complications that were caused by the defective design of the machine, inadequate warnings and a lack of training provided by the manufacturer for surgeons. The first trial ended in a defense verdict last month.