MULTIDEBRIDER HANDPIECE, ANGLED

Additional Manufacturer Narrative

THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE DEVICE RETURN EVALUATION, REVIEW OF THE DEVICE HISTORY RECORDS (DHR) AND DEVICE EVALUATION. THE DEVICE HISTORY RECORDS FOR THIS DEVICE WERE REVIEWED AND ALL RECORDS INDICATED THAT THE PRODUCT WAS MANUFACTURED ACCORDING TO ALL APPLICABLE PROCEDURES AND MET FINAL PRODUCT RELEASE CRITERIA. NO ABNORMALITIES WERE FOUND. IT WAS REPORTED THAT DURING PREPARATION FOR USE THE DEVICE HANDPIECE MDHP100A FOUND NO ACTIVATION. THE MDHP100A WAS RECEIVED FOR THE REPORTED ISSUE OF NOT ACTIVATING. THE HANDPIECE WAS VISUALLY INSPECTED. THERE WERE NO DISCERNIBLE ABNORMALITIES FOUND. IN ADDITION, FUNCTIONAL TESTING WAS PERFORMED. THE HANDPIECE PASSED ALL FUNCTIONAL TESTS, THE SERVICE TEAM WAS UNABLE TO DUPLICATE THE USER REPORTED FAILURE. DUE TO NO DAMAGES CONFIRMED, A ROOT CAUSE COULD NOT BE IDENTIFIED. OLYMPUS WILL CONTINUE TO MONITOR COMPLAINTS FOR THIS DEVICE.

Additional Manufacturer Narrative

THE SUBJECT DEVICE HAS NOT YET BEEN RECEIVED FOR EVALUATION. THE CAUSE OF THE ISSUE CANNOT BE DETERMINED AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE THIS REPORT WILL BE SUPPLEMENTED ACCORDINGLY.

Description of Event or Problem

IT WAS REPORTED THAT DURING PREPARATION FOR USE THE DEVICE HANDPIECE MDHP100A FOUND NO ACTIVATION. ACCORDING TO THE REPORTER, THE BURR UNIT WAS REMOVED AND WAS REATTACHED HOWEVER, THE ISSUE WAS NOT RESOLVED. THE DEVICE WAS REPLACED WITH ANOTHER HANDPIECE AND NO OTHER FURTHER DETAILS REGARDING THE EVENT WAS PROVIDED. NO PATIENT INVOLVEMENT ON THIS EVENT, NO USER HARM OR INJURY WAS REPORTED.