COVIDIEN

Additional Manufacturer Narrative

IT WAS REPORTED THAT DURING AN UNSPECIFIED GENERAL LAPAROSCOPIC CASE, THE JAWS OF THE REPROCESSED COVIDIEN LIGASURE BLUNT TIP, SEALER/DIVIDER, NANO-COATED, COMPATIBLE WITH FT10 GENERATOR 37CM, PARTIALLY SPLIT APART RESULTING IN SMALL SHAVINGS AND METAL SHARDS TO ENTER THE WOUND. NO INFORMATION WAS PROVIDED ON HOW THE SHAVINGS OR SHARDS WERE RETRIEVED FROM THE PATIENT'S WOUNDS. THERE WAS NO SERIOUS INJURY REPORTED RELATED TO THIS EVENT. DUE TO THE REPORTED INCIDENT AND IN AN ABUNDANCE OF CAUTION, THIS MEDWATCH IS BEING FILED. THE SAMPLE WAS RETURNED FOR EVALUATION AND UPON INSPECTION OF THE RECEIVED DEVICE, IT WAS OBSERVED THAT THERE WAS A SMALL STAPLE LODGED INSIDE THE DEVICE JAWS. THIS WAS DETERMINED TO BE THE ROOT CAUSE OF THE REPORTED METAL SHARDS/SHAVINGS. THE DEVICE JAWS WERE NOT SPLIT OR OTHERWISE DAMAGED. THE SOURCE OF THE STAPLE COULD NOT BE CONFIRMED AT THIS TIME. THE DEVICE HAD BEEN REPROCESSED ONE TIME. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED AND THIS REVIEW INDICATED THAT ALL PROCESSES WERE CONDUCTED AS REQUIRED AT THE TIME THE REPORTED LOT WAS PROCESSED. NO ADDITIONAL INFORMATION IS AVAILABLE. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

Description of Event or Problem

IT WAS REPORTED THAT THE JAWS OF THE REPROCESSED COVIDIEN LIGASURE BLUNT TIP PARTIALLY SPLIT APART RESULTING IN SMALL SHAVINGS AND METAL SHARDS TO ENTER THE WOUND.