MEDLINE RENEWAL REPROCESSED LIGASURE IMPACT

Additional Manufacturer Narrative

THE DEVICE IN QUESTION WAS RETURNED TO MEDLINE RENEWAL FOR EVALUATION, AND WE CONFIRMED THAT IT WAS A MEDLINE RENEWAL REPROCESSED COVIDIEN LIGASURE IMPACT CURVED, LARGE JAW, OPEN SEALER/DIVIDER, MODEL LF4318. WE PERFORMED A THOROUGH INSPECTION AND INVESTIGATION INTO THE INCIDENT. OUR INVESTIGATION CONFIRMED THAT THE DEVICE DID NOT FUNCTION AS EXPECTED, CONFIRMING THE INITIAL INCIDENT REPORT. THE ROOT CAUSE OF THE DEVICE FAILURE IS UNKNOWN AND THE INCIDENT IS STILL UNDER INVESTIGATION. IF ADDITIONAL INFORMATION BECOMES AVAILABLE THEN THIS REPORT WILL BE UPDATED WITH THE NEW INFORMATION. THE CUSTOMER CONFIRMED THAT NO ADVERSE PATIENT CONSEQUENCE OR MEDICAL INTERVENTION WAS REQUIRED AS A RESULT OF THE INCIDENT. HOWEVER, DUE TO THE REPORTED DELAY IN THE PROCEDURE MEDLINE RENEWAL IS FILING THIS MEDWATCH REPORT. (B)(4).

Description of Event or Problem

MEDLINE RENEWAL RECEIVED A REPORT INDICATING THAT A REPROCESSED COVIDIEN LIGASURE IMPACT, MODEL LF4318, SOUNDED INTERMITTENT ALARMS AND PRODUCED LOW ENERGY DURING USE. ANOTHER REPROCESSED DEVICE WAS READILY AVAILABLE TO COMPLETE THE PROCEDURE, THEREFORE NO PATIENT HARM WAS REPORTED AS A RESULT OF THE INCIDENT.