BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAVITRON SELECT SPS G124 GENERATOR(DNA)

    MDR report key: 23199539 · Received October 2, 2025

    Report

    Report Number
    2424472-2025-00128
    Event Type
    Malfunction
    Date Received
    October 2, 2025
    Report Date
    October 13, 2025
    Manufacturer
    DENTSPLY LLC
    Product Code
    ELC
    PMA / PMN Number
    K970123
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    10/06/25 EVALUATION TECH: JCB. EMH HP ;CABLE, CONN/GUN CABLE DAMAGED. INCONSISTENT OR NO ACTIVATION OF FOOT PEDAL IN SECOND POSITION, DAMAGED HANDPIECE CABLE RESTRICTING WATER FLOW. DEBRIS BUILDUP IN THE WATER FILTER. WILL REPLACE DAMAGED/WORN COMPONENTS AND RECALIBRATE UNIT TO FACTORY SPECS UPON ESTIMATE APPROVAL HPC-CODE # N/A. ST-CODE #N/A.

    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 SELECT G124, THEY ALLEGE THAT THEY HAVE NO WATER AND THE UNIT GETS WARM,; NO INJURY RESULTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    278435 CAVITRON SELECT SPS G124 GENERATOR(DNA) SCALER, ULTRASONIC ELC DENTSPLY LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown