Intuitive Surgical is recalling certain cannulae components used with the da Vinci Surgical System, due to a risk that they may be damaged during use and could be hard to replace, potentially posing a risk of injury for patients undergoing robotic surgery.
The da Vinci robot cannulae recall (PDF) was announced in a field safety notice issued by Intuitive Surgical on March 25. According to the manufacturer of the surgical robot, the components may be prone to become damaged during use.
“If cannula damage occurs during a procedure, then there is a possibility that the cannula or associated instruments may come in inadvertent contact with tissue,” the letter warns. “This contact may cause tissue injury and require additional surgical and/or medical intervention.”
According to Intuitive Surgical, at least one patient has suffered injuries that may have been caused by a damaged cannula, which occurred when the tube rotated and pierced the patient’s abdominal muscle. The company states that the complications in that case did not require surgical or medical intervention.
The recall affects 129 lots of its Single-Site 5mm Curved Cannulae for the da Vinci robot. The recall affects components manufactured between December 2010 and August 2012, which were shipped to the United States, Belgium, Canada, Denmark, France, Germany, Greece, Italy, Lebanon, Monaco, The Netherlands, Norway, Saudi Arabia, Switzerland, Turkey, and the United Kingdom.
The company says it has received 98 reports of damaged Single-Site 5mm Curved Cannulae from the affected lots, estimating that the problem may affect about one out of every 200 components.
The company is calling on its customers to use instructions in the recall letter to identify affected components, inspect them for damage, and quarantine those parts if they appear to be damaged.
Da Vinci Robot Problems
The da Vinci Surgical System is a remote control robot featuring four arms that are controlled by a surgeon through the use of hand and foot controls while sitting at a console that provides a virtual reality representation of the patient’s internal organs. The surgical robot has been increasingly used at hospitals throughout the U.S. in recent years for a number of different urologic, laparoscopic, gynecologic and non-cardiovascular thoracoscopic surgical procedures and thoracoscopically assisted cardiotomy procedures.
The recall is just the latest in a series of da Vinci robot problems for Intuitive Surgical over the past year. The surgical robots have come under increasing scrutiny amid concerns about the adequacy of training provided for surgeons and reports of patients suffering burns, tears and other internal injuries following robotic surgery.
Late last year, the company announced problems that affected 110,000 Large Needle Driver and Mega Needle Driver Endowrist instruments. That action was proceeded just two weeks before by another da Vinci robot recall, which affected 1,400 units with arms that could potentially stall during surgery.
In July, it was reported that a Class 2 da Vinci robot recall was issued after it was discovered that about 30 of the surgical systems were not properly tested before being distributed. Although all of the robots were subsequently tested in the field and no problems were discovered, concerns emerged about how the factory testing was not in compliance with UL standards.
The FDA issued a warning letter to Intuitive Surgical in that instance, indicating that the company failed to adequately report da Vinci robot problems.
In May, Intuitive Surgical issued a warning to health care providers about problems with the da Vinci robot cauterizing scissors, which are known as “Hot Shears”, indicating that the components may develop micro-cracks that allow electrosurgical energy to “leak” to nearby tissue and cause thermal injury or burns to internal organs.
In addition, Intuitive Surgical also faces a growing number of da Vinci robot lawsuits brought by patients who suffered complications that were allegedly caused by the robot, including internal injuries and deaths.
Amid the recalls and complaints, Intuitive surgical announced on April 1 that the FDA had approved a new version of the robot, the da Vinci Xi Surgical System. The company claims that the new robot has smaller, thinner arms with newly designed joints and an overhead architecture that allows the robot to access all of the patient’s anatomy without being repositioned, and gives it a greater range of motion.