BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAVITRON PLUS TAP-ON(DNA) G136

    MDR report key: 17888752 · Received October 6, 2023

    Report

    Report Number
    2424472-2023-00049
    Event Type
    Malfunction
    Date Received
    October 6, 2023
    Report Date
    November 21, 2023
    Manufacturer
    DENTSPLY LLC
    Product Code
    ELC
    UDI-DI
    D00381614251
    PMA / PMN Number
    K052334
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULT: SAK 000: FOUND NO ISSUES WITH HEATING OF THE HANDPIECE USING A KNOWN GOOD INSERT. RAN UNIT AT FULL POWER, USING FSI-10 WITH WATER FLOW SET AT 35 CC/MIN FOR EXTENDED PERIOD WITH OUT ISSUE. CUSTOMER PROBABLY IS USING AFTERMARKET/DAMAGED/WORN INSERTS CAUSING INDUCTIVE HEATING. ONLY NOTABLE ISSUE FOUND, WAS WATER FILTER IS MISSING AND BATTERIES IN FOOT CONTROL HAVE TRIGGERED "BATTERY LIGHT" TO ILLUMINATE. ESTIMATED UNIT ACCORDINGLY.

    Additional Manufacturer Narrative · 0

    SINCE AN OVERHEATING INSERT COULD NECESSITATE MEDICAL/SURGICAL INTERVENTION TO PRECLUDE PERMANENT DAMAGE TO A BODY STRUCTURE OR PERMANENT IMPAIRMENT OF A BODY FUNCTION, THIS MALFUNCTION WOULD BE LIKELY TO CAUSE/CONTRIBUTE TO A SERIOUS INJURY SHOULD IT RECUR. AS SUCH, THIS EVENT MEETS THE CRITERIA FOR REPORTABILITY PER 21 CFR PART 803. THE DEVICE IS AVAILABLE FOR EVALUATION, THOUGH HAS NOT BEEN RETURNED AS OF THIS REPORT. EVALUATION RESULTS WILL BE SUBMITTED AS THEY BECOME AVAILABLE.

    Description of Event or Problem · 0

    WHILE THE CUSTOMER WAS USING A G136 CAVITRON PLUS THEY ALLEGE THAT THE HANDPIECE AND INSERT ARE HEATING UP WHEN IN USE, NO WATER TO HANDPIECE. NO INJURY WAS REPORTED FROM THE ALLEGED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1072132 CAVITRON PLUS TAP-ON(DNA) G136 SCALER, ULTRASONIC ELC DENTSPLY LLC D00381614251

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown