BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAVITRON PLUS TAP-ON(DNA) G136

    MDR report key: 21462949 · Received February 25, 2025

    Report

    Report Number
    2424472-2025-00023
    Event Type
    Malfunction
    Date Received
    February 25, 2025
    Report Date
    April 7, 2025
    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

    03/18/25 REPAIR TECH: TL. W4H WATER SOL,ISO VALVE DAMAGED. POOR WATER PRESSURE REGULATION, DEBRIS BUILDUP IN THE WATER FILTER. DEBRIS BUILDUP IN THE HANDPIECE CABLE, CORRODED CONTACT PINS ON THE STERI-MATE HANDPIECE. REPLACED DAMAGED/WORN COMPONENTS AND RECALIBRATED UNIT TO FACTORY SPECS. QA -DS. HANDPIECE # :OLD 201404 -- NEW 202407. HANDPIECE CABLE # :OLD 05220 -- NEW12240.

    Additional Manufacturer Narrative · 0

    THERE HAS BEEN A PREVIOUS REPORT RECEIVED WHERE LACK OF WATER FLOW HAS CAUSED AN OVERHEATING INSERT. 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 USING A CAVITRON PLUS G136, THEY ALLEGE THAT THEY HAVE LOW WATER FLOW AND THE HANDPIECE IS HEATING UP, NO INJURY RESULTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    594743 CAVITRON PLUS TAP-ON(DNA) G136 SCALER, ULTRASONIC ELC DENTSPLY LLC D00381614251

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown