Intuitive—Large Needle Driver and Mega Needle Driver EndoWrist Instruments Used with da Vinci Surgical Systems: Jaw Insert May Detach
November 27, 2013 | Risk Management News
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In a November 15, 2013, Urgent Medical Device Recall letter submitted by an ECRI Institute member hospital, Intuitive states that the jaw insert on the instruments below may detach. Intuitive also states that a jaw insert detaching during surgery may lead to a device fragment falling into the patient. Intuitive further states that it has received 102 reports of damaged or detached jaw inserts on the above instruments and that of those reports, 30 were in regard to inserts falling off during surgery and falling into the patient. Of those 30, there was one report of the fragment falling into the patient and not being retrieved, necessitating a second surgery to remove the fragment; in the other 29 reports, the fragments were immediately retrieved. Intuitive further states that the remaining 72 reports were for damaged or detached inserts that did not fall into a patient. Intuitive states that it has determined that this problem is caused by variability in the manufacturing process for bonding the inserts to the instrument jaws. Intuitive also states that these reports represent 0.01% of...