BURR, 4MM, 70DEG, DIAMOND TAPER, 5/PK

Additional Manufacturer Narrative

THE DEVICE WAS RETURNED TO OLYMPUS FOR EVALUATION, THE USER¿S REQUEST WAS UNABLE TO BE REPLICATED. DURING VISUAL INSPECTION, SOME MINOR WEAR WAS NOTED ON THE DISTAL END AND REDDISH FOREIGN MATERIAL NEAR THE MIDDLE OF THE OUTER BLADE IMPLYING THAT THE DEVICE HAS BEEN USED. NO OTHER OBSERVATIONS WERE FOUND, NO WOBBLE OR VIBRATIONS FROM THE DEVICE. THE DEVICE HISTORY RECORDS (DHR) FOR THIS PRODUCT HAVE BEEN REVIEWED. ALL RECORDS INDICATE THAT THE PRODUCT WAS MANUFACTURED, TESTED IN ACCORDANCE WITH ALL APPLICABLE PROCEDURES, AND MET ALL FINAL PRODUCT RELEASE CRITERIA. PER THE TESTING PROCEDURES (ELECTRICAL, TORQUE, BENDING), THE BLADES ARE TESTED FOR ELECTRICAL AND PHYSICAL TOLERANCES WHILE REMAINING FUNCTIONAL. BASED ON THE TESTING PROCEDURES AND DHR, IT IS LIKELY THAT THE DAMAGES INCURRED WERE LIKELY DURING TRANSPORTATION OR USE. OLYMPUS WILL CONTINUE TO MONITOR COMPLAINTS FOR THIS DEVICE THROUGH REGULAR TRENDING ACTIVITIES AS DEFINED BY OSTA QMS PROCEDURE.

Description of Event or Problem

THE USER FACILITY REPORTED THAT THE DIAMOND TAPER BLADE STOPPED WORKING. THE REGISTERED NURSE AT THE USER FACILITY REPORTED THAT THE ISSUE OCCURRED DURING THE MIDDLE OF A THERAPEUTIC PROCEDURE. THE INTENDED PROCEDURE WAS COMPLETED WITH NO DELAY USING A DIFFERENT SIMILAR DEVICE. THE DEVICE HAD NO ANOMALIES, CABLE DAMAGE NOR ERROR MESSAGES. NO PATIENT INJURY WAS REPORTED. NO ADDITIONAL INFORMATION HAS BEEN OBTAINED.