HALL SURGICAL BUR GUARD, MEDIUM

Description of Event or Problem

THE CUSTOMER REPORTED THAT DURING USE OF THIS BUR GUARD IN AN ORAL SURGERY PROCEDURE, IT OVERHEATED RESULTING IN A BURN TO THE PATIENT'S LIP. THE PATIENT WAS TREATED WITH CORTICOSTEROID CREAM AND IS HEALING WELL.

Additional Manufacturer Narrative

INVESTIGATION FINDINGS: CONMED LINVATEC RECEIVED THIS BUR GUARD FOR EVALUATION AND VERIFIED THE REPORTED PROBLEM. DURING TESTING THE BUR GUARD EXCEEDED MANUFACTURER TEMPERATURE SPECIFICATIONS RELATED TO WORN AND CORRODED BEARINGS. FURTHER EVALUATION FOUND THIS UNIT OVERDUE FOR PREVENTIVE MAINTENANCE; LAST DATE OF REPAIR DOCUMENTED WAS 2007. AN EVALUATION OF THE CONCOMITANT HANDPIECE FOUND IT OPERATED TO MANUFACTURER SPECIFICATIONS. THE INFORMATION FOR USE (IFU) WARNS THE USER OF THE FOLLOWING: PRIOR TO EACH USE, ALL EQUIPMENT MUST BE INSPECTED FOR PROPER OPERATION. OVERHEATING MIGHT OCCUR IF BEARINGS ARE WORN OR ARE NOT KEPT CLEAN. IF OVERHEATING OCCURS, DISCONTINUE USE AND RETURN FOR SERVICE. GUARDS ARE TO BE RETURNED TO LINVATEC/HALL SURGICAL EVERY SIX MONTHS FOR ROUTINE MAINTENANCE. BUR GUARD TEST PROCEDURE: PRIOR TO ATTACHING THE BUR GUARD; CHECK FOR WORN BEARINGS BY INSERTING A BUR INTO THE NOSE OF THE BUR GUARD. WHILE HOLDING THE BUR, SPIN THE GUARD. THE GUARD SHOULD SPIN FREELY AROUND THE BUR SHAFT WITHOUT RESTRICTIONS. ATTACH THE BUR AND GUARD TO THE DRILL USING THE FOLLOWING INSTRUCTIONS. RUN THE INSTRUMENT FOR AT LEAST 30 SECONDS, CAREFULLY FEELING THE TIP OF THE GUARD FOR HEAT. IF HEAT IS NOTICED, DISCONTINUE USE AND RETURN FOR SERVICE. THE CUSTOMER WILL BE PROVIDED ADDITIONAL INFORMATION ON THE CARE AND HANDLING OF THIS DEVICE.