April 7, 2014 — Intuitive Surgical has initiated a recall (PDF) for a cannula (tube that is used to insert or remove fluid) that is used with the da Vinci Surgical Robot after receiving 98 reports of damaged cannulae.
Intuitive recommends that customers should visually inspect the cannula to check for cracks, broken welds, tube wall abnormalities, tube migration, or improper bowl-tube orientation. According to the recall notification:
“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 person was injured when a cannula tube rotated, causing another instrument to pierce the patient’s abdominal muscle.
Intuitive blames the problem on improper placement of the cannulae in the Single-Site port. The company has updated instructions for inspecting and handling the cannula. Approximately 19,000 procedures have been performed with the device, and Intuitive estimates the damage occurrence rate at 0.52%.
The recall affects 129 lots of Single-Site 5-mm reusable curved cannulae. The products were sold from December 2010 until August 2012 and sold globally to 600 customers.
Recommendation
Intuitive will conduct a recall in two phases. In Phase I, customers should visually inspect the affected cannula, look for signs of damage, quarantine any damaged cannulae, and return them to Intuitive for a replacement. In Phase II, Intuitive will replace all recalled cannulae with an improved product that is stronger and less likely to be damaged by improper placement.
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