MASTERMATIC LUX M05 L

Description of Event or Problem

DURING THE PROCEDURE THE DR WORKED ON THE UPPER TOOTH 16, THE DOCTOR NOTICE THAT THE RUBBER DAM HAD MELTED ON THE LOWER LIP WAS BURNED. AS A MEDICAL CARE OR PRESCRIPTION DRUG IT WAS NECESSARY TO PUT SOME VASELINE TO THE LIP AND PRESCRIBE HIM SOME ANTIBIOTICS AND PAIN MEDS.

Additional Manufacturer Narrative

THE ISSUE DOES NOT POSE A UNKNOWN RISK. IT IS ALREADY CONTENT OF THE CURRENT RISK ANALYSIS. TO AVOID SUCH ISSUES (OVERHEATING) THE USER INSTRUCTION CONTAINS ALREADY SEVERAL NOTES, WARNINGS AND REQUESTS HOW TO PREPARE AND MAINTAIN THE HANDPIECE FOR EACH TREATMENT AND HOW TO USE: 2.2 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: 2.3 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. 2.3 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.