Intuitive—5 mm Cannulae Used with da Vinci S, Si, and Si-e Surgical Systems: Inappropriate Handling May Damage or Bend Cannula
June 5, 2013 | Risk Management News
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In a May 14, 2013, Urgent Medical Device Correction letter submitted by an ECRI Institute member hospital, Intuitive states that it has received reports of the cannulae below being damaged, potentially leading to difficulty inserting or using 5 mm surgical instruments. Intuitive also states that the cannulae below have been shown to be safe and effective when used in accordance with product labeling; however, the cannulae may be damaged or bent by inappropriate handling. This may result in the generation of particulate debris, which can drop into the patient, and/or the loss of smooth instrument motion. The manufacturer has not confirmed the information provided in the source material.