HALL SURGICAL BUR GUARD, MEDIUM
Received Aug 22, 2008 · Event occurred Jul 30, 2008
Report 1017294-2008-00290 · MDR key 1137285
Device
Product problems
- Hot Oil Leak
- Overheating of Device
Patient
NK
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
THE CUSTOMER REPORTED THAT DURING USE OF THIS BUR GUARD, IT GOT HOT AND STARTED SPITTING OIL. THE HEAT WAS FELT BY THE USER, WHICH PROMPTED DISCONTINUED USE OF THE DEVICE. ANOTHER BUR GUARD WAS OBTAINED TO COMPLETE THE PROCEDURE, AND THERE WAS NO REPORT OF INJURY WITH THIS EVENT.
Additional Manufacturer Narrative
INVESTIGATION: CONMED LINVATEC RECEIVED THIS BUR GUARD FOR EVALUATION. DURING TESTING OF THIS UNIT, IT EXCEEDED MANUFACTURER TEMPERATURE SPECIFICATIONS RELATED TO A WORN BEARING AND CORROSION INSIDE THE DEVICE. AT NO TIME, DID THE DEVICE SPATTER ANY OIL. THE HANDPIECE IN USE AT THE TIME OF THIS EVENT WAS NOT RETURNED FOR EVALUATION, BECAUSE THE CUSTOMER REPORTED NO PROBLEM WITH THE DEVICE. 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. 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 TO LINVATEC/HALL SURGICAL FOR SERVICE. THE USER WILL BE SENT ADDITIONAL INFORMATION ON CARE OF THIS DEVICE.