BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROTAPER UNIVERSAL OVEN

    MDR report key: 4926170 · Received July 16, 2015

    Report

    Report Number
    2320721-2015-00010
    Event Type
    Malfunction
    Date Received
    July 16, 2015
    Date of Event
    June 16, 2015
    Report Date
    June 16, 2015
    Manufacturer
    DENTSPLY TULSA DENTAL SPECIALTIES
    Product Code
    EKM
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    POWER CORD WIRES BROKEN AND SHORTING OUT, AND PART OF THE OUTER SHEATH IS MISSING. HOLDERS WON'T LATCH. HEATING TUBES CLOGGED WITH GUTTA PERCHA. ALL OTHER FUNCTIONS WORK PROPERLY. REPLACED POWER CORD AND HOLDERS. CLEANED GUTTA PERCHA, AS MUCH AS POSSIBLE, FROM HEAT TUBES. UNIT PASSED HEAT TEST. ALL OTHER FUNCTIONS NORMAL.

    Additional Manufacturer Narrative · 1

    WHILE NO SERIOUS INJURY RESULTED IN THIS EVENT, IF THIS MALFUNCTION RECURRED, IT COULD CAUSE OUR CONTRIBUTE TO A SERIOUS INJURY OR REQUIRE MEDICAL OR SURGICAL INTERVENTION TO PRECLUDE SUCH. THIS EVENT, THEREFORE, IS REPORTABLE PER 21 CFR 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

    IN THIS EVENT IT WAS REPORTED THAT A PROTAPER UNIVERSAL OVEN WAS SMOKING, SHORTED OUT AND HAS FRAYED WIRES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    464378 PROTAPER UNIVERSAL OVEN GUTT-PERCHA EKM DENTSPLY TULSA DENTAL SPECIALTIES NA

    Patients

    Seq Age Sex Outcome Treatment
    1