COVIDIEN

Additional Manufacturer Narrative

IT WAS REPORTED THAT THE JAWS OF THE REPROCESSED COVIDIEN LIGASURE BLUNT TIP, SEALER/DIVIDER, NANO-COATED, COMPATIBLE WITH FT10 GENERATOR 37CM, WOULD NOT FULLY OPEN DURING AN UNSPECIFIED GENERAL LAPAROSCOPIC CASE. IT WAS ADDED THAT THE PATIENT WAS ADMINISTERED ADDITIONAL ANESTHESIA AND OVERALL PROCEDURE TIME WAS EXTENDED BEYOND EXPECTED AS A RESULT OF THE TIME NEEDED TO OBTAIN A NEW INSTRUMENT. GENERAL ANESTHESIA WAS USED; HOWEVER, THERE WAS NO REPORT OF ANY ADVERSE PATIENT CONSEQUENCE AND NO EFFECT ON THE PATIENT'S STABILITY AS A RESULT OF THE INCIDENT. THERE WAS NO SERIOUS INJURY OR FOLLOW UP CARE REPORTED RELATED TO THE EVENT. DUE TO THE REPORTED DEVICE FAILURE AND THE REPORTED NEED FOR ADDITIONAL ANESTHESIA RESULTING IN PROCEDURE TIME EXTENSION, THIS MEDWATCH IS BEING FILED. THE SAMPLE WAS RETURNED FOR EVALUATION AND IT WAS OBSERVED THAT THERE WAS A SMALL STAPLE LODGED INSIDE THE DEVICE JAWS. THE SOURCE OF THE STAPLE COULD NOT BE CONFIRMED. THE DEVICE HAD BEEN REPROCESSED ONE TIME. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED AND THIS INDICATED THAT ALL PROCESSES WERE CONDUCTED AS REQUIRED AT THE TIME THE REPORTED LOT WAS PROCESSED. 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 JAWS OF THE REPROCESSED COVIDIEN LIGASURE BLUNT TIP WOULD NOT FULLY OPEN DURING A LAPAROSCOPIC CASE. ADDITIONAL ANESTHESIA WAS REQUIRED AND PROCEDURE TIME EXTENDED BEYOND EXPECTED.