ETHICON

Additional Manufacturer Narrative

IT WAS REPORTED THAT THE TOP OF THE REPROCESSED ETHICON ENDOPATH® XCEL¿ DILATING TIP TROCAR, W/STABILITY SLEEVE, (GOLD) 12MM X 150MM CAME OFF AND CAUSED THE DEVICE TO BREAK INTO MULTIPLE PIECES. THE DEVICE WAS REPORTEDLY BEING USED WITH A DAVINCI ROBOT. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, NO FURTHER PATIENT, PRODUCT, PROCEDURAL AND EVENT DETAILS ARE AVAILABLE. IT WAS NOT CONFIRMED IF PIECES OF THE DEVICE REACHED THE SURGICAL SITE; HOWEVER, IT WAS REPORTED THAT NO DEVICE PIECES WERE LEFT IN THE PATIENT. DUE TO THE REPORTED EVENT, THIS MEDWATCH IS BEING FILED. THE SAMPLE WAS RETURNED FOR EVALUATION AND THE DEVICE ISSUE WAS CONFIRMED. UPON INSPECTION OF THE RECEIVED DEVICE, IT WAS OBSERVED THAT THE DEVICE HAD BROKEN APART INTO SEVERAL PIECES. THE TROCAR (INNER) WAS NOT RETURNED WITH THE DEVICE. THE DEVICE HAD BEEN REPROCESSED ONE TIME. THE LOT NUMBER ASSOCIATED WITH THE DEVICE WAS NOT REPORTED AND THE PACKAGE/LABEL WAS NOT RETURNED WITH THE DEVICE. A REVIEW OF THE DEVICE HISTORY RECORD / INTERNAL STOCK CHECK COULD NOT BE PERFORMED AS NO LOT INFORMATION WAS PROVIDED. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED AT THIS TIME. NO ADDITIONAL INFORMATION IS AVAILABLE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

Description of Event or Problem

IT WAS REPORTED THAT THE TOP OF THE REPROCESSED ETHICON XCEL TROCAR CAME OFF AND THE DEVICE BROKE INTO MULTIPLE PIECES.