BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAVITRON SELECT SPS G124 GENERATOR(DNA)

    MDR report key: 22978368 · Received September 5, 2025

    Report

    Report Number
    2424472-2025-00119
    Event Type
    Malfunction
    Date Received
    September 5, 2025
    Report Date
    October 6, 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

    09/23/2025. EVALUATION TECH: (B)(6). EMN HP; CABLE, CONN/GUN CABLE KINK/PINCH/TWIST INTERMITTENT OPERATION DUE TO AN OPEN CONDITION IN THE FOOTSWITCH CABLE, BLOCKAGE IN THE HANDPIECE CABLE CAUSING RESTRICTED WATER FLOW. DEBRIS BUILDUP IN THE 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. HPC: 1110. HP: 0910. DHR REVIEW IS NOT REQUIRED BECAUSE THE PRODUCT WAS RETURNED FOR EVALUATION, AND THE DESCRIBED FAILURE MODE IS A KNOWN HAZARD.

    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 SPS G124, THEY ALLEGE THAT THEY HAVE NO WATER AND THE HANDPIECE GETS HOT; NO INJURY RESULTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1975712 CAVITRON SELECT SPS G124 GENERATOR(DNA) SCALER, ULTRASONIC ELC DENTSPLY LLC D003813021

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown