BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAVITRON SELECT SPS G124 GENERATOR(DNA)

    MDR report key: 23017456 · Received September 10, 2025

    Report

    Report Number
    2424472-2025-00123
    Event Type
    Malfunction
    Date Received
    September 10, 2025
    Report Date
    October 13, 2025
    Manufacturer
    DENTSPLY LLC
    Product Code
    ELC
    UDI-DI
    D003813021
    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

    (B)(6) ON (B)(6) 2025. HPC#: 03200 03250. ST/HP#: N/A. (B)(6). ALL DAMAGED AND WORN-OUT COMPONENTS HAVE BEEN REPLACED. THE UNIT HAVE BEEN REPAIRED, CALIBRATED AND TESTED TO FACTORY'S SPECS. NO OTHER FAULTS WERE FOUND. ST/HP WAS NOT SENT IN FOR EVALUATIONS.

    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 CAVITRON SELECT SPS G124, THEY ALLEGE THAT THE INSERT OVER HEATED. NO INJURY WAS REPORTED FROM THE ALLEGED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2517847 CAVITRON SELECT SPS G124 GENERATOR(DNA) SCALER, ULTRASONIC ELC DENTSPLY LLC D003813021

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown