HANDPIECE, ELECTRIC DERMATOME

Additional Manufacturer Narrative

THIS INCIDENT IS BEING RECORDED UNDER (B)(4). G2: FOREIGN - EVENT OCCURRED IN JAPAN. E1: TELEPHONE- (B)(6). THE DEVICE WILL BE RETURNED FOR ANALYSIS, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.

Description of Event or Problem

IT WAS REPORTED THAT THE DEVICE NEEDED REPAIR AS THE MOTOR WAS NOT ROTATING SMOOTHLY. NO PATIENT INVOLVEMENT WAS NOTED AS A RESULT DILIGENCE IS COMPLETE.