Intuitive Surgical is voluntarily recalling certain lots of Single-Site® 5mm Reusable Curved Cannulae because incorrect placement of the cannulae in the Single-Site port could potentially cause damage. 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.

The da Vinci Surgical System is a medical robotic technology used for minimally invasive surgery.  When used according to instructions, the cannulae are unlikely to become damaged. The total reported cannulae damage occurrence rate is approximately 0.52%.  In addition to the recall, Intuitive Surgical is revising its Single-Site labeling to instruct users how to inspect cannulae prior to use and to appropriately handle cannulae during use.

Affected lots were manufactured between December 2010 and August 2012.  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.  For more information see intuitivesurgical.com.

[1] Intuitive Surgical "Important Product Information" (March 26, 2014).

The FDA has issued a final report on the small sample survey of surgeons who use the da Vinci Surgical System.  The da Vinci Surgical System is a computer-assisted device designed to facilitate minimally invasive surgery.  The survey was conducted to better understand the challenges of the system versus conventional surgical procedures.  All surgeons reported that learning to use the system was the biggest challenge.  Reported benefits of the system included fewer patient complications and shorter hospital stays.  Suggestions for improving the system ranged from changes in the system design and training, to mounting the device on the ceiling to allow more space in smaller rooms.

[1] FDA, Center for Devices and Radiological Health, Office of Surveillance and Biometrics, Medical Product Safety Network, Small Sample Survey - Final Report, Topic: da Vinci Surgical System (November 2013).