REPROCESSED ARTHROSCOPIC SHAVER

Additional Manufacturer Narrative

THE DEVICE IN QUESTION WAS RETURNED TO FOR EVALUATION. THE LOT NUMBER WAS PROVIDED, AND A REVIEW OF THE REPROCESSING RECORDS WAS PERFORMED. ALL PROCESSES WERE CONDUCTED AS REQUIRED. THE REPORTED ISSUE WAS CONFIRMED, AND THE TIP WAS RETRIEVED FROM THE PATIENT. DUE TO THE LACK OF INFORMATION SURROUNDING THE INCIDENT, MEDLINE RENEWAL DOES NOT HAVE ENOUGH INFORMATION TO DETERMINE THE ROOT CAUSE OF THE FAILURE. IF MORE INFORMATION IS PROVIDED THEN THIS REPORT WILL BE UPDATED. THERE WAS NO REPORT OF ADVERSE PATIENT CONSEQUENCE OR ADDITIONAL MEDICAL INTERVENTION AS A RESULT OF THE INCIDENT. HOWEVER, IN AN ABUNDANCE OF CAUTION, WE ARE FILING THIS MEDWATCH REPORT.

Description of Event or Problem

WE RECEIVED A REPORT INDICATING THAT THE TIP OF A REPROCESSED ARTHROSCOPIC SHAVER DETACHED AND FELL INTO THE PATIENT DURING USE. THE PHYSICIAN WAS ABLE TO LOCATE AND REMOVE THE DETACHED TIP WITHOUT PATIENT CONSEQUENCE OR ADDITIONAL MEDICAL INTERVENTION.