MASTERMATIC LUX M25 L

Additional Manufacturer Narrative

THE INITIAL REPORTER STATED THAT A PATIENT SUSTAINED A BURN DURING A DENTAL PROCEDURE INVOLVING THE DEVICE. AT THE TIME OF THE INITIAL REPORT, THE REPORTER ADVISED THAT THE PATIENT DID NOT REQUIRE MEDICAL TREATMENT AND WAS REPORTED TO BE DOING WELL. DURING A SUBSEQUENT FOLLOW-UP WITH THE REPORTING PRACTICE, IT WAS COMMUNICATED THAT THE PATIENT LATER SOUGHT MEDICAL EVALUATION AND TREATMENT FROM A PLASTIC SURGEON AS A RESULT OF THE REPORTED BURN. NO ADDITIONAL INFORMATION REGARDING THE PATIENT'S DIAGNOSIS, THE SEVERITY OF THE INJURY, THE TREATMENT PROVIDED, OR THE PATIENT'S CLINICAL OUTCOME HAS BEEN MADE AVAILABLE DESPITE FOLLOW-UP EFFORTS. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION; THEREFORE, NO DEVICE EXAMINATION OR FAILURE ANALYSIS HAS BEEN PERFORMED. THE INVESTIGATION REMAINS LIMITED DUE TO THE ABSENCE OF THE DEVICE AND THE LACK OF ADDITIONAL CLINICAL INFORMATION. TO AVOID SUCH ISSUES THE IFU CONTAINS ALREADY SEVERAL NOTES, WARNINGS AND REQUESTS HOW TO PREPARE AND MAINTAIN THE HANDPIECE FOR EACH TREATMENT AND HOW TO USE IT: 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. 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. 2.3 TECHNICAL CONDITION: A DAMAGED PRODUCT 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, DENTAL BUR IS NOT SEATED FIRMLY IN THE HANDPIECE, TO ENSURE OPTIMUM FUNCTION AND TO PREVENT PROPERTY DAMAGE, PLEASE COMPLY WITH THE FOLLOWING INSTRUCTIONS: SERVICE THE MEDICAL DEVICE REGULARLY WITH CARE PRODUCTS AND SYSTEMS AS DESCRIBED IN THE INSTRUCTIONS FOR USE. THE DEVICE SHOULD BE REPROCESSED AND STORED IN A DRY LOCATION, ACCORDING TO INSTRUCTIONS, IF IT IS NOT TO BE USED FOR AN EXTENDED PERIOD OF TIME. 6.1 CHECKING FOR MALFUNCTIONS: 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

HEAD OF THE HANDPIECE GETS VERY HOT DURING A DENTAL PROCEDURE. THE INITIAL REPORTER CONFIRMS SLIGHT BURN AT PATIENTS LIP. THE DENTAL DEALER ON SITE AT THE TIME OF THE REPORT, (B)(6) 2026, STATED THE THAT PATIENT DID NOT REQUIRE MEDICAL INTERVENTION AND WAS OK. ON OUR SECOND ATTEMPT TO CONTACT THE DENTAL PRACTICE, IT WAS MENTIONED THAT THE PATIENT HAD TO GO TO A PLASTIC SURGEON DUE TO THE REPORTED INJURY.