ADVANTAGE TURBO, 2-BUTTON SHAVER

Description of Event or Problem

THE CUSTOMER REPORTED THAT DURING USE OF THIS SHAVER HANDPIECE IN SURGERY, IT GOT HOT. THERE WAS NO PATIENT INJURY RELATED TO THIS EVENT.

Additional Manufacturer Narrative

INVESTIGATION RESULTS: AN EVALUATION OF THIS DEVICE CONFIRMED THE REPORTED PROBLEM OF HOT. DURING TESTING OF THIS UNIT, THE MOTOR AND GEARBOX WAS NOISY AND GRINDING AND THE MOTOR FAILED SPEED AND TORQUE TESTING. A VISUAL EXAMINATION FOUND EVIDENCE OF SALT LIKE DEPOSITS INSIDE THE HANDPIECE. THE INSTRUCTIONS FOR USE (IFU) PROVIDES THE FOLLOWING INFORMATION TO THE USER: PRIOR TO EACH USE, INSPECT HANDPIECE FOR PROPER OPERATION AND ENSURE ALL ACCESSORIES ARE CORRECTLY AND COMPLETELY ATTACHED TO THE HANDPIECE. PREOPERATIVE FUNCTIONAL TEST. PRIOR TO EACH USE, PERFORM THE FOLLOWING PREOPERATIVE FUNCTIONAL TEST: INSERT BUR OR BLADE INTO THE HANDPIECE BY ALIGNING ONE OF THE SLOTS IN THE COLLET WITH THE KEY ON THE BLADE HUB. GENTLY PULL ON THE CUTTING ACCESSORY TO ENSURE IT IS PROPERLY SEATED. VERIFY THAT THE CONSOLE PROPERLY RECOGNIZES THE HANDPIECE AND CUTTING ACCESSORY. PRESS THE DIRECTION SELECT BUTTON TO ENSURE THAT IT FUNCTIONS PROPERLY. WITH THE HANDPIECE RUNNING, OBSERVE ANY ABNORMAL NOISES, VIBRATIONS, OR HEAT RISE. VERIFY THAT THE CONSOLE DISPLAYS THE PROPER SPEED. DEPRESS THE ON/OFF BUTTON A SECOND TIME TO STOP THE HANDPIECE. IF ANY OPERATING DIFFICULTIES OCCUR, RETURN THE HANDPIECE FOR SERVICE. CAUTION: WHEN OPERATING BURS AT HIGHER THAN 6000 RPM, YOU MUST ENSURE THAT IRRIGATION FLUID IS FLOWING THROUGH THE HANDPIECE BEFORE ACTIVATING THE HANDPIECE. FAILURE TO DO SO MAY CAUSE THE BUR HUBS TO MELT DUE TO. THE USER FACILITY WAS UNABLE TO PROVIDE INFORMATION REGARDING HOW THE DEVICE WAS BEING USED AT THE TIME OF THIS OCCURRENCE. EDUCATIONAL INFORMATION WILL BE PROVIDED TO THE CUSTOMER.