Intuitive Recalls da Vinci Surgical Robot System Cannulae Due to Risk of Patient InjuriesMar 31, 2014
Intuitive Surgical is recalling some of the cannulae used during procedures with its da Vinci robotic surgery system. The company says they can be damaged if not installed properly by the user and could injure the patient.
Intuitive has recalled 129 lots of its Single-Site 5mm reusable curved cannulae – tubes inserted for the introduction or removal of fluids – made between December 2010 and August 2012. A patient was allegedly injured by cannula damage when the device pierced the abdominal muscle, according to MassDevice.com. An Intuitive Surgical spokesman said in an email that "[a]ffected products were sold to approximately 600 customers and involve approximately 5,200 cannulae."
A company press release said the “main contributor to this damage is incorrect placement of the cannulae in the Single-Site port. If it becomes damaged during surgery, there is the possibility that the cannula or instrument may come in inadvertent contact with tissue,” MassDevice.com reports. In 19,000 procedures performed using the affected devices, there were 98 incidents of damage to cannulae, Intuitive said.
The da Vinci surgical robot system has been allegedly associated with serious injuries, including tears, burns and perforations to arteries and organs; some of these injuries have allegedly led to death. The remote controlled robot is promoted as giving the surgeon more range of motion than the human hand, and providing less invasive surgery with reduced recovery time. But several lawsuits filed against Intuitive Surgical over alleged da Vinci injuries claim surgeons are not receiving adequate training on the device before they use the robot unsupervised. And the benefits of robotic surgery are not consistent for all types of procedures. Robotic surgery has shown benefits in head and neck surgery, but it is not necessarily superior to traditional methods in gall bladder removals, according to a study published last year in the Journal for Healthcare Quality.
In a three-year comparison of robotically assisted hysterectomies versus traditional laparoscopic surgeries, the Journal of the American Medical Association reported that the robot added an average of $2,000 per procedure, with no significant clinical advantages, according to Kaiser Health News.