BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAVITRON PLUS TAP-ON,115V DOM-G136(DNA)

    MDR report key: 19818869 · Received July 24, 2024

    Report

    Report Number
    2424472-2024-00066
    Event Type
    Malfunction
    Date Received
    July 24, 2024
    Report Date
    August 14, 2024
    Manufacturer
    DENTSPLY LLC
    Product Code
    ELC
    UDI-DI
    D00381840011
    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

    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.

    Additional Manufacturer Narrative · 0

    NOTES: 08/05/2024, REPAIR TECH: DTS. EMN HP, CABLE, CONN/GUN CABLE KINK/PINCH/TWIST. DEAD BATTERIES IN WIRELESS FOOT PEDAL. WORN AND PEELING FOOT CONTROL PAD. BLOCKAGE IN THE HANDPIECE CABLE CAUSING RESTRICTED WATER FLOW. DEBRIS BUILDUP IN THE WATER FILTER. REPLACED DAMAGED/WORN COMPONENTS AND RECALIBRATED UNIT TO FACTORY SPECS. QA-RB ***NO HANDPIECE, AUX CABLE RECEIVED FOR EVALUATION*** ***FOR PROPER EVALUATION ALWAYS SEND IN ALL PARTS THAT GO ALONG WITH THE UNIT TO BE LOOKED AT*** ***NO HP, OLD HDPC 01/2024, NEW HDPC 03/2024*** ************* WITHIN WARRANTY? NO. ************ WITHIN WARRANTY? NO. ************* WITHIN WARRANTY? NO.

    Description of Event or Problem · 0

    WHILE THE CUSTOMER WAS USING A CAVITRON PLUS G136 THEY ALLEGE THAT THE UNIT AND INSERT ARE HEATING UP. NO INJURY WAS REPORTED FROM THE ALLEGED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    356032 CAVITRON PLUS TAP-ON,115V DOM-G136(DNA) SCALER, ULTRASONIC ELC DENTSPLY LLC D00381840011

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown