COVIDIEN

Additional Manufacturer Narrative

IT WAS REPORTED THAT THE REPROCESSED COVIDIEN LIGASURE BLUNT TIP, SEALER/DIVIDER, NANO-COATED, COMPATIBLE WITH FT10 GENERATOR 37CM "FAILED" DURING AN UNIDENTIFIED PROCEDURE. AS A RESULT OF THE INSTRUMENT FAILURE, THE PATIENT WAS LEFT ON THE TABLE WITH AN OPEN INCISION AND THE OVERALL PROCEDURE TIME WAS EXTENDED BEYOND EXPECTED, AS A NEW INSTRUMENT HAD TO BE COLLECTED. THE PATIENT REPORTEDLY REQUIRED ADDITIONAL ANESTHESIA AS A RESULT OF THE INCIDENT. THERE WAS NO SERIOUS INJURY REPORTED RELATED TO THIS EVENT. DUE TO THE REPORTED EVENT, THIS MEDWATCH IS BEING FILED. THE DEVICE WAS RETURNED FOR EVALUATION. UPON INSPECTION OF THE RECEIVED DEVICE, IT WAS OBSERVED THAT ONE OF THE POWER PINS WAS BENT. DURING SIMULATED USE, THE DEVICE APPEARED TO FUNCTION CORRECTLY AS THE APPROPRIATE TONES SOUNDED ON THE GENERATOR. AFTER THE SEALING CYCLE WAS COMPLETE, IT WAS OBSERVED THAT NO ENERGY HAD TRANSFERRED TO THE DISTAL END OF THE DEVICE, AS THE TEST MEDIA WAS NOT SEALED. THE DEVICE DID NOT FUNCTION AS EXPECTED AND THE REPORTED ISSUE WAS CONFIRMED. 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 REPROCESSED COVIDIEN LIGASURE BLUNT TIP "FAILED" AND PATIENT REQUIRED ADDITIONAL ANESTHESIA SINCE PROCEDURE EXTENDED BEYOND EXPECTED TIME.