BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    25LPR GENTLEPOWER LUX CONTRA ANGLE

    MDR report key: 23678912 · Received December 1, 2025

    Report

    Report Number
    3003637274-2025-00018
    Event Type
    Malfunction
    Date Received
    December 1, 2025
    Date of Event
    November 5, 2025
    Report Date
    November 27, 2025
    Manufacturer
    KAVO DENTAL GMBH
    Product Code
    EGS
    PMA / PMN Number
    K073478
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRIOR TO THE REPAIR THE INSTRUMENT WAS TESTED AGAINST THE SPECIFICATION. DURING THE TEST RUN THE FOLLOWING RESULTS WERE IDENTIFIED: CHUCK DAMAGED: CAN'T INSERT BUR. GUIDE BUSHING DAMAGED: CAUSES BAD VIBRATION. BEARINGS WORN AND GRITTY: HANDPIECE RUNS HOT. POWER CONSUMPTION HIGH. WHEN TESTING AND RUNNING THIS 25LPR THERE WAS A BLACK RESIDUE COMING OUT WHERE THE SPRAY INSERT IS. IT WAS EXTREMELY LOUD WHEN RUNNING AND MAKING A GRINDING NOISE. IT WAS SMOKING AND RUNNING EXTREMELY HOT AFTER A SHORT TIME RUNNING IT. SO OVERALL THE HANDPIECE WAS SOLD IN 2011. THERE WAS NO SERVICE HISTORY COMPREHENSIBLE FOR KAVO SERVICE SINCE THEN. THE HANDPIECE WAS IN VERY BAD CONDITIONS REGARDING CARE AND MAINTENANCE. 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: HAZARD FROM THE USE OF HANDPIECES EQUIPPED WITH ELECTRONIC MICROMOTORS. ELECTRONIC MICROMOTORS GENERATE MUCH MORE ENERGY THAN CONVENTIONAL PNEUMATIC TURBINES AND MOTORS. GIVEN THE HIGHER TORQUE AND SPEED, HANDPIECES THAT ARE POORLY SERVICED, DAMAGED OR USED IMPROPERLY CAN OVERHEAT WHICH CAN CAUSE SERIOUS BURN INJURIES TO THE PATIENT. OBSERVE THE FOLLOWING POINTS. THE FOLLOWING GUIDELINES MUST BE OBSERVED TO ENSURE SAVE USE OF THE ELECTRICALLY DRIVEN HANDPIECES: THE SERVICE INSTRUCTIONS FOR HANDPIECES MUST BE PRECISELY FOLLOWING WHEN USING KAVO SPRAY OR QUATTROCARE CARE SYSTEMS. BEFORE EACH USE, THE HANDPIECE MUST BE CHECKED FOR EXTERNAL DAMAGE. BEFORE EACH USE, PERFORM A TEST RUN WITH THE HANDPIECE, AND WATCH FOR ATYPICAL HEATING AND UNUSUAL NOISE AND VIBRATION. IMMEDIATELY STOP USING HANDPIECES THAT ACT UNUSUAL. NEVER PRESS THE PUSHBUTTON DURING OPERATION. THIS ALSO INCLUDES LIFTING THE CHEEK OR TONGUE! HEATING OF THE PRODUCT. BURNS OR PRODUCT DAMAGE FROM OVERHEATING. DO NOT USE THE PRODUCT IF IT IS IRREGULARLY HEATED. THE MEDICAL DEVICE IS TOO HOT WHILE IDLING: CHECK THE AMOUNT OF COOLING AIR. THE MEDICAL DEVICE IS TOO HOT WHILE WORKING: CARING FOR THE MEDICAL DEVICE. PREMATURE WEAR AND MALFUNCTIONS FROM IMPROPER SERVICING AND CARE. REDUCED PRODUCT LIFE. PERFORM PROPER CARE REGULARLY!

    Description of Event or Problem · 0

    DURING A TREATMENT HANDPIECE GOT HOT AND CAUSED A CONTACT BURN TO THE PATIENT. THE RESULT WAS A BURN TO THE TISSUE ON THE TONGUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2745555 25LPR GENTLEPOWER LUX CONTRA ANGLE DENTAL HANDPIECE EGS KAVO DENTAL GMBH 25LPR

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Unknown