COVIDIEN

Additional Manufacturer Narrative

IT WAS INITIALLY REPORTED THAT DURING A MASTECTOMY, THE REPROCESSED LIGASURE¿ SMALL JAW INSTRUMENT (PURPLE/WHITE), COMPATIBLE WITH FT10 GENERATOR 18.8 CM, BECAME "TOO HOT" AND THE TISSUE WAS "COMPROMISED". DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, NO FURTHER PATIENT, PRODUCT, PROCEDURAL OR EVENT DETAILS ARE AVAILABLE. DUE TO THE REPORTED "COMPROMISED" TISSUE, THIS MEDWATCH IS BEING FILED. THE SAMPLE WAS RETURNED FOR EVALUATION AND THE COMPLAINT COULD NOT BE CONFIRMED. NO EXCESSIVE THERMAL SPREAD WAS OBSERVED DURING FUNCTIONAL TESTING. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED AND THIS INDICATED THAT ALL PROCESSES WERE CONDUCTED AS REQUIRED AT THE TIME THE LOT WAS PROCESSED. A DEFINITIVE ROOT CAUSE FOR THE REPORTED ISSUE 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 DURING A MASTECTOMY, THE REPROCESSED COVIDIEN LIGASURE¿ SMALL JAW INSTRUMENT GOT "TOO HOT" RESULTING IN TISSUE BEING "COMPROMISED."