COVIDIEN

Additional Manufacturer Narrative

IT WAS REPORTED THAT THREE REPROCESSED LIGASURE¿ SMALL JAW INSTRUMENT LF1212AC TISSUE SEALERS ERROR-OUT DURING AN UNIDENTIFIED PARATHYROID PROCEDURE. THE REPORTED DEVICES REPORTEDLY WOULD NOT COMPLETE HEMOSTASIS. PER REPORT, THE SURGICAL PROCEDURE TIME WAS EXTENDED AND PATIENT REQUIRED ADDITIONAL ANESTHESIA MEDICATION. GENERAL ANESTHESIA WAS USED AND THERE WAS NO REPORT OF ANY ADVERSE PATIENT CONSEQUENCE AND NO EFFECT ON THE PATIENT'S STABILITY AS A RESULT OF THE INCIDENT. ANOTHER DEVICE WAS OPENED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. 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. TWO OF THE THREE DEVICES THAT FAILED WERE RETURNED FOR EVALUATION. THE REPORTED COMPLAINT IS CONFIRMED THROUGH FUNCTIONAL TESTING. REVIEW OF THE DEVICE HISTORY RECORD INDICATED THAT ALL PROCESSES WERE CONDUCTED AS REQUIRED. A ROOT CAUSE COULD NOT BE DETERMINED AT THIS TIME. 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 REPROCESSED COVIDIEN LIGASURE¿ SMALL JAW INSTRUMENT TISSUE SEALER ERROR OUT DURING USE AND TOTAL PROCEDURE TIME WAS EXTENDED. THE PATIENT RECEIVED ADDITIONAL ANESTHESIA MEDICATION.