UPDATED March 28, 2014, with details from Intuitive Surgical.
Intuitive Surgical (NSDQ:ISRG) said it’s recalling some of the cannulae used during procedures with its da Vinci robotic surgery system, saying they can become damaged if not installed properly by the user.
Sunnyvale, Calif.-based Intuitive said it’s recalling 129 lots of its Single-Site 5mm reusable curved cannulae made between December 2010 and August 2012. One patient was allegedly injured by cannula damage when the device pierced the abdominal muscle. The injury did not require surgical or medical intervention, the company said. An Intuitive Surgical spokesman told MassDevice.com via email that “[a]ffected products were sold to approximately 600 customers and involve approximately 5,200 cannulae.”
"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. In addition, the surgeon may need to replace the damaged cannula during surgery or convert to a multi-port approach if another cannula is not available," according to a press release. "When used according to instructions, the cannulae are unlikely to become damaged."
Of the 19,000 procedures performed using the affected devices, there were 98 incidents of damage to the cannulae, for an damage occurrence rate of 0.52%, Intuitive said.
The medical device company said it’s revising the labeling for the Single-Site devices "to instruct users how to inspect cannulae prior to use and to appropriately handle cannulae during use." Devices found to be damaged after inspection should be quarantined and returned to Intuitive, which will replace them once the inventory becomes available, according to the release.
"All affected cannulae will be replaced with a new version that can withstand higher force and is less likely to become damaged by incorrect placement," Intuitive said. The affected devices were shipped to customers in Belgium, Canada, Denmark, France, Germany, Greece, Italy, Lebanon, Monaco, Netherlands, Norway Saudi Arabia, Switzerland, Turkey, the U.K. and the U.S., the company said.
Intuitive also said it’s received 3 reports of damaged cannulae "outside of the products subject to the recall."
"Worldwide there have been approximately 17,000 users of the unaffected lots of Single-Site 5mm curved cannulae, resulting in a reported cannulae damage occurrence rate of 0.018% (1 in 5,800 procedures)," according to the release. Those devices were shipped to customers in Australia, Belgium, Brazil, Chile, Colombia, Denmark, France, Germany India Italy, Lebanon, Monaco, Netherlands, Norway, Romania, Saudi Arabia, South Korea, Spain, Sweden, Switzerland, Turkey, the U.K. and the U.S., Intuitive said.
