MASTERMATIC LUX M05 L

Additional Manufacturer Narrative

THE HANDPIECE IS BEING SENT BACK AND EVALUATED. THERE ARE SMALL DENTS AROUND THE HEAD THAT COULD IMPACT THE FRICTION OF THE BEARING. THIS FRICTION COULD CAUSES THE HANDPIECE TO HEAT UP. DAMAGES OF THE HOUSING LIKE THIS COULD HAVE BEEN CAUSED BY INTENSIVE TREATMENT OR BY DROPPING DOWN. 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: 2.3 TECHNICAL CONDITION: A DAMAGED PRODUCT OR DAMAGED OR NOT KAVO ORIGINAL COMPONENTS COULD INJURE PATIENTS, USERS OR THIRD PARTIES. USE THE DEVICE AND COMPONENTS ONLY IF THERE IS NO 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. IF THE FOLLOWING DEFECTS OCCUR, STOP WORKING AND HAVE THE SERVICE PERSONNEL CARRY OUT REPAIR WORK: MALFUNCTIONS; DAMAGE (E.G. CAUSED BY BEING DROPPED); IRREGULAR RUNNING NOISE; EXCESSIVE VIBRATION; OVERHEATING; BUR IS NOT SEATED FIRMLY IN THE HANDPIECE. 6.1 CHECKING FOR MALFUNCTIONS: CAUTION: OVERHEATING OF THE DEVICE. BURN INJURY OR PRODUCT DAMAGE DUE TO OVER-HEATING. IF THE DEVICE OVERHEATS, STOP WORKING AND HAVE THE SERVICE PERSONNEL REPAIR THE DEVICE.

Description of Event or Problem

DURING A EDUCATIONAL PROCEDURE IN THE DENTAL UNIVERSITY THE HANDPIECE HEATS UP AND VIBRATE. THE STUDENT CANNOT HOLD IT IN THE HAND. THERE WAS NO PATIENT INVOLVED. AND THERE WAS NO INJURY AT ALL.