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Patient 1
EVALUATION FOUND COLLET BEARINGS WORN. RAN UNIT FOR 1 MIN OUT OF A 3 MIN RUN TEST AND THE TEMP WAS 149DEG. MAXIMUM TEMPERATURE SHOULD BE 110?F. LAST PREVENTIVE MAINTENANCE WAS PERFORMED 04/09/18 AND THE COLLET ASSEMBLY WAS REPLACED, HOWEVER, DEVICE WAS USED IN THE FIELD FOR OVER 6 MONTHS WITH AN UNKNOWN NUMBER OF USES. PREVIOUS HISTORY SHOWS REPEATED FAILURE DUE TO CORROSION AND LACK OF CONSISTENCY IN COMPLIANCE TO PREVENTIVE MAINTENANCE SCHEDULE. A TWO-YEAR REVIEW OF COMPLAINT HISTORY REVEALED THERE HAS BEEN A TOTAL OF 33 COMPLAINTS, REGARDING 33 DEVICES, FOR THIS DEVICE FAMILY AND FAILURE MODE. DURING THIS SAME TIME FRAME (B)(4) DEVICES HAVE BEEN MANUFACTURED AND SHIPPED WORLDWIDE. SHOULD ALL THE COMPLAINT DEVICES HAVE BEEN FOUND CONFIRMED FOR THIS REPORTED FAILURE, THE RATE OF FAILURE WOULD BE (B)(4). PER THE INSTRUCTIONS FOR USE, THE USER IS ADVISED THE FOLLOWING: WARNINGS AND PRECAUTIONS: REGULAR SERVICE IS REQUIRED TO KEEP THE SURGAIRTOME TWO HANDPIECE AT ITS OPTIMUM OPERATING PERFORMANCE. WARNINGS: PRIOR TO EACH USE, INSPECT ALL EQUIPMENT FOR PROPER OPERATION. CONTINUALLY CHECK ALL HANDPIECES AND ATTACHMENTS FOR OVERHEATING. IF OVERHEATING IS SENSED, IMMEDIATELY DISCONTINUE USE AND RETURN THE EQUIPMENT FOR SERVICE. OVERHEATING OF THE BUR OR BIT MAY CAUSE DAMAGE TO THE BUR OR BIT AND MAY CAUSE BURNS OR THERMAL NECROSIS. FAILURE TO FOLLOW THE MAINTENANCE SCHEDULE...COULD RESULT IN REDUCED INSTRUMENT PERFORMANCE OR OVERHEATING OF THE HANDPIECE OR ATTACHMENT. OVERHEATING CAN LEAD TO POSSIBLE BURN INJURY TO THE PATIENT OR MEDICAL PERSONNEL. ROTATION OF HANDPIECE USAGE PER DAY WILL ASSIST WITH PROPER PERFORMANCE. THIS ISSUE WILL CONTINUE TO BE MONITORED THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY.