BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAVITRON SELECT SPS G124 GENERATOR(DNA)

    MDR report key: 19635076 · Received June 28, 2024

    Report

    Report Number
    2424472-2024-00060
    Event Type
    Malfunction
    Date Received
    June 28, 2024
    Report Date
    July 30, 2024
    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

    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

    (B)(6) 2024, UNIT SERIAL NUMBER-(B)(6). HANDPIECE/STERIMATE LOT NUMBER- (1*-OLD-08030-NEW-202402)/ (2*-06162), HANDPIECE CABLE LOT NUMBER-(OLD-11220) (NEW-04240), REPAIR TECH: GPB, QA: MO, ROOT CAUSE: W4E WATER SOL, ISO VALVE CLOGGED. NO WATER FLOW DUE TO A CLOGGED WATER SOLENOID, DEBRIS BUILDUP IN THE HANDPIECE CABLE CAUSING POOR WATER FLOW, CORRODED CONTACT PINS ON THE STERIMATE/HANDPIECE, DEBRIS BUILDUP IN THE WATER SUPPLY HOSE AND LEAKING NEAR THE BLACK LURES. NOTE: REPLACED DAMAGED/WORN COMPONENTS AND RECALIBRATED UNIT TO FACTORY SPECS.

    Description of Event or Problem · 0

    WHILE USING A CAVITRON SELECT SPS G124, THEY ALLEGE THAT HAVE SLOW WATER FLOW AND THE HANDPIECE GETS HOT; NO INJURY RESULTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2185494 CAVITRON SELECT SPS G124 GENERATOR(DNA) SCALER, ULTRASONIC ELC DENTSPLY LLC D003813021

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown