April 7, 2014 — Intuitive Surgical, manufacturer of the da Vinci Surgical Robot, has announced a recall (PDF) for 129 lots of its Single-Site 5-mm reusable curved cannulae after receiving reports of injuries due to cannula damage.
Customers should visually inspect the tube for cracks or tube wall abnormalities, paying particularly close attention to the area just above and below the remote center (indicated by the dark band). Damaged products may have cracks, tube migration, or improper bowl-tube orientation.
According to the recall notice, published on March 25, warns:
“If cannula damage occurs during a procedure, then there is a possibility that the cannula or associated instrument may come in inadvertent contact with tissue. This contact may cause tissue injury and require additional surgery and/or medical intervention.”
At least one patient injury was attributed to cannula damage. In this case, the cannula tube rotated slightly, which contributed to an instrument piercing the patient’s abdominal muscle.
Intuitive said that the injuries were caused by improper placement of the cannulae in the Single-Site port. The company has received 98 reports of damage to the cannulae in 19,000 procedures using the affected devices. Intuitive has updated the label on the Single-Site device to provide instructions for inspecting and handling the cannulae.
The recalled lots were manufactured from December 2010 until August 2012 and sold to 600 customers worldwide.
What Should I Do?
Intuitive recommends inspecting recalled devices for damage. Only products found to be damaged should be quarantined and returned to Intuitive. Products that are not damaged should still be used until Intuitive has enough replacement cannulae for everyone. Intuitive will replace all recalled cannulae with an improved device that can withstand higher force and is less likely to be damaged by improper placement.