REPROCESSED HARMONIC SCALPEL

Additional Manufacturer Narrative

THE DEVICE IN QUESTION WAS RETURNED FOR EVALUATION, AND WE CONFIRMED THAT THE DEVICE HAD BEEN REPROCESSED. THE REPORTED ISSUE WAS CONFIRMED. THERE WERE NO OTHER DEVICE DEFECTS OBSERVED DURING OUR INVESTIGATION. OUR INVESTIGATION ALSO INCLUDED A REVIEW OF THE DEVICE HISTORY RECORD. WE CONFIRMED THAT ALL VALIDATED PROCESSES WERE PERFORMED ACCORDING TO SPECIFICATION. THE USER FACILITY DID NOT NOTIFY OUR FIRM AT THE TIME OF THE INCIDENT, THEREFORE FEW DETAILS SURROUNDING THE INCIDENT ARE KNOWN AT THIS TIME. THE RETRIEVAL OF THE BLACK TISSUE PAD CAUSED A DELAY IN PROCEDURE BUT THERE WERE NO REPORTED INJURIES OR CONSEQUENCES TO THE PATIENT. ADDITIONALLY, NO MEDICAL INTERVENTION WAS REQUIRED AS A RESULT OF THE INCIDENT. IN AN ABUNDANCE OF CAUTION, WE ARE FILING THIS MEDWATCH REPORT.

Description of Event or Problem

WE RECEIVED A REPORT INDICATING THAT THE BLACK TISSUE PAD LOCATED ON THE DISTAL TIP OF A REPROCESSED HARMONIC SCALPEL DETACHED DURING USE. THE PHYSICIAN WAS ABLE TO FIND AND REMOVE THE TIP.