REPROCESSED ARTHROSCOPIC SHAVER

Additional Manufacturer Narrative

THE DEVICE IN QUESTION WAS NOT RETURNED FOR EVALUATION. HOWEVER, A PICTURE OF THE DEVICE WAS PROVIDED BY THE USER FACILITY. WE CONFIRMED THAT THE DEVICE WAS REPROCESSED AND THAT THE TIP HAD DETACHED. THE LOT NUMBER WAS ALSO PROVIDED, AND A REVIEW OF THE REPROCESSING RECORDS WAS PERFORMED. ALL PROCESSES WERE CONDUCTED AS REQUIRED PRIOR TO RELEASE. THE REPORTED ISSUE WAS CONFIRMED. THE USER FACILITY CONFIRMED THAT THE TIP WAS RETRIEVED FROM THE PATIENT AT THE TIME OF THE PROCEDURE; HOWEVER THE INCIDENT EXTENDED THE PROCEDURE TIME BY APPROXIMATELY 10 MINUTES. A NEW DEVICE AND A BAG OF FLUID WERE REQUIRED TO COMPLETE THE CASE. WE DO NOT HAVE ENOUGH INFORMATION TO DETERMINE THE ROOT CAUSE OF THE FAILURE AT THIS TIME, HOWEVER 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 DURING USE. THE PHYSICIAN WAS ABLE TO LOCATE AND REMOVE THE DETACHED TIP WITH A GRASPER. A NEW DEVICE AND A BAG OF FLUID WERE NEEDED TO COMPLETE THE CASE.