MASTERMATIC LUX M05 L

Additional Manufacturer Narrative

THE HANDPIECE IS BEING SENT BACK AND EVALUATED. PUSH BUTTON STUCK IN RUBBING ON CHUCK RELEASE WHILE HANDPIECE RUNNING. HEATING UP QUICKLY DUE TO DENTED HEAD. CHUCK WEAK - BUR NOT SECURE. AS WELL THE BEARINGS WAS WORN AND GRITTY - HANDPIECE RUNS HOT. A DEFORMED HANDPIECE HEAD CAUSES THAT ROTATING COMPONENTS GRIND AGAINST THE HEAD HOUSING. THIS FRICTION CAUSES THE HANDPIECE TO HEAT UP QUICKLY. DENTED HEAD LIKE THIS COULD HAVE BEEN CAUSED BY THE HANDPIECE BEING DROPPED DOWN. THE ISSUE DOES NOT POSE A UNKNOWN RISK. IT IS ALREADY CONTENT OF THE CURRENT RISK ANALYSIS. THE IFU THEREFORE CONTAINS ALREADY SEVERAL WARNINGS AND NOTES HOW TO USE THE PRODUCT CORRECTLY. IT CLEARLY POINTS OUT THAT THE INSTRUMENT NEVER USED TO KEEP THE CHEEK, TONQUE OR LIP AT A DISTANCE. THIS IS THE REASON WHY THE PUSH BUTTON WAS PRESSED WHILE INSTRUMENT WAS RUNNING. ISSUE WOULD BE AVOIDABLE IF USER WOULD FOLLOW THE IFU. TO AVOID SUCH ISSUES THE USER INSTRUCTION CONTAINS ALREADY SEVERAL NOTES, WARNINGS AND REQUESTS HOW TO PREPARE AND MAINTAIN THE HANDPIECE FOR EACH TREATMENT AND HOW TO USE IT: IMPROPER USE: BECAUSE THE OPERATION WITH AN ELECTRIC MOTOR INVOLVES A HIGHER TORQUE, PATIENTS, USERS AND OTHER PEOPLE CAN SUFFER INJURIES AND SERIOUS BURNS IF AN INSTRUMENT IS DAMAGED OR USED IMPROPERLY. CHECK THE TECHNICAL CONDITION BEFORE EACH USE. ALSO REFER TO: TECHNICAL CONDITION, PAGE 21. NEVER PRESS THE PUSH-BUTTON DURING OPERATION OF THE DEVICE. NEVER USE THE INSTRUMENT TO KEEP THE CHEEK, TONGUE OR LIP AT A DISTANCE. NEVER TOUCH SOFT TISSUE WITH THE HANDPIECE HEAD OR INSTRUMENT COVER. DO NOT USE THE MEDICAL DEVICE AS A LIGHT PROBE. TECHNICAL CONDITION: A DAMAGED PRODUCT OR DAMAGED OR NOT KAVO ORIGINAL COMPONENTS COULD INJURE PATIENTS, USERS OR THIRD PARTIES. ONLY OPERATE DEVICES OR COMPONENTS IF THEY SHOW NO SIGNS OF DAMAGE ON THE OUTSIDE. CHECK TO MAKE SURE THAT THE DEVICE IS WORKING PROPERLY AND IS IN SATISFACTORY CONDITION BEFORE EACH USE. HAVE PARTS WITH SITES OF BREAKAGE OR SURFACE CHANGES CHECKED BY THE SERVICE PERSONNEL. IF THE FOLLOWING DEFECTS OCCUR, STOP WORKING AND HAVE THE SERVICE PERSONNEL CARRY OUT REPAIR WORK: MALFUNCTIONS: DAMAGE (E.G., FROM DROPPING); IRREGULAR RUNNING NOISE; EXCESSIVE VIBRATION; OVERHEATING. CUTS, INFECTION AND BURN INJURY. NEVER PUSH THE PRESS-BUTTON WHILE THE DENTAL BUR IS ROTATING. DO NOT TOUCH THE DENTAL BUR WHILE IT IS ROTATING. NEVER TOUCH SOFT TISSUE WITH THE HANDPIECE HEAD OR INSTRUMENT COVER. REMOVE THE DENTAL BUR FROM THE HANDPIECE AFTER TREATMENT TO AVOID INJURY AND INFECTION DURING STORAGE. OVERHEATING OF THE DEVICE. BURNS OR PRODUCT DAMAGE FROM OVERHEATING. IF THE DEVICE OVERHEATS, STOP WORKING AND HAVE THE SERVICE PERSONNEL REPAIR THE DEVICE.

Description of Event or Problem

WHILE FILLING CAVITY, THE HANDPIECE OVERHEATED AND CAUSING A BURN TO THE PATIENT'S LIP. PATIENT IS DOING FINE. THE DOCTOR APPLIED VASELINE TO THE AREA ON THE LIP AS A MEDICAL ATTENTION.