BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAVITRON BUILT-IN ULTRASONIC SCALER

    MDR report key: 6682516 · Received June 30, 2017

    Report

    Report Number
    2424472-2017-00061
    Event Type
    Malfunction
    Date Received
    June 30, 2017
    Report Date
    November 20, 2017
    Manufacturer
    DENTSPLY PROFESSIONAL
    Product Code
    ELC
    PMA / PMN Number
    K052334
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION FOUND THE EFZ POWER SUPPLY BOARD SHORTED.

    Additional Manufacturer Narrative · 1

    WHILE NO SERIOUS INJURY RESULTED IN THIS EVENT, THERE HAS BEEN A PREVIOUS REPORT RECEIVED WHERE AN OVERHEATING INSERT RESULTED IN A SERIOUS INJURY. THEREFORE, IT MUST BE PRESUMED THAT RECURRENCE OF THIS MALFUNCTION COULD POSSIBLY CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR REQUIRE MEDICAL OR SURGICAL INTERVENTION TO PRECLUDE SUCH. AS SUCH, THIS EVENT IS REPORTABLE PER 21CFR PART 803. THE DEVICE IS AVAILABLE FOR EVALUATION, THOUGH RESULTS ARE NOT AVAILABLE AS OF THIS REPORT. EVALUATION RESULTS WILL BE SUBMITTED AS THEY BECOME AVAILABLE.

    Description of Event or Problem · 1

    WHILE USING A G-139 SCALER, THE HANDPIECE, WIRING, AND INSERTS WERE GETTING HOT TO TOUCH; NO INJURY RESULTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    462855 CAVITRON BUILT-IN ULTRASONIC SCALER SCALER, ULTRASONIC ELC DENTSPLY PROFESSIONAL G139 NA

    Patients

    Seq Age Sex Outcome Treatment
    1