BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PWR PIEZO LED HANDPIECE

    MDR report key: 24402335 · Received February 20, 2026

    Report

    Report Number
    1416605-2026-00001
    Event Type
    Injury
    Date Received
    February 20, 2026
    Date of Event
    January 26, 2026
    Report Date
    February 20, 2026
    Manufacturer
    HU-FRIEDY MANUFACTURING CO., LLC
    Product Code
    ELC
    UDI-DI
    10889950142728
    PMA / PMN Number
    K140965
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE HANDPIECE WAS TESTED ON THE PWR PAIR DEVICE AND WAS FOUND TO BE NON-FUNCTIONAL, WITH THE HANDPIECE INDICATOR LED CONTINUOUSLY ILLUMINATED. THE DEVICE ENTERED FAIL-SAFE MODE DURING TESTING, PREVENTING AN ELECTRIC SHOCK OR OVERHEATING. THE HANDPIECE FAILED THE INSULATION TEST AND IS THEREFORE CONSIDERED UNUSABLE.

    Description of Event or Problem · 0

    WHILE USING THE DEVICE, THE HANDPIECE SERVICE LIGHT ON THE UNIT LIT UP, AND THE HANDPIECE BECAME EXTREMELY HOT, CAUSING AN ELECTRIC SHOCK TO THE DOCTOR'S HAND THAT WAS HOLDING IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    460195 PWR PIEZO LED HANDPIECE PIEZO, ULTRASONIC ELC HU-FRIEDY MANUFACTURING CO., LLC UPHPLED 10889950142728

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other