BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 20735843 · Received November 20, 2024

    Report

    Report Number
    2424472-2024-00103
    Event Type
    Malfunction
    Date Received
    November 20, 2024
    Report Date
    February 13, 2025
    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

    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.

    Additional Manufacturer Narrative · 0

    HPC-06190. ST-N/A. 11/26/2024 EVALUATION TECH: JCB. EMH HP; CABLE, CONN/GUN CABLE DAMAGED. WORN BATTERY DOOR, BLOCKAGE IN THE HANDPIECE CABLE CAUSING RESTRICTED WATER FLOW. NO WATER FLOW DUE TO A CLOGGED WATER SOLENOID, DEBRIS BUILDUP IN THE WATER SUPPLY HOSE, DEBRIS BUILDUP IN THE WATER FILTER. WILL REPLACE DAMAGED/WORN COMPONENTS AND RECALIBRATE UNIT TO FACTORY SPECS UPON ESTIMATE APPROVAL.. NO HANDPIECE RECEIVED FOR EVALUATION.

    Description of Event or Problem · 0

    WHILE USING A CAVITRON PLUS G136, THEY ALLEGE THAT THEY HAVE LACK OF WATER FLOW AND THE HANDPIECE IS OVERHEATING, NO INJURY RESULTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2153227 CAVITRON PLUS TAP-ON,115V DOM-G136(DNA) SCALER, ULTRASONIC ELC DENTSPLY LLC D00381840011

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown