BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAVITRON SELECT SPS G124

    MDR report key: 20733438 · Received November 20, 2024

    Report

    Report Number
    2424472-2024-00102
    Event Type
    Malfunction
    Date Received
    November 20, 2024
    Report Date
    February 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

    HPC-08240 NEW. ST-2023082. 11/25/2024 REPAIR TECH: JCB. WOE HOSE, TUBING, CLOGGED. BLOCKAGE IN THE HANDPIECE CABLE CAUSING RESTRICTED WATER FLOW. DEBRIS BUILDUP IN THE WATER SOLENOID, DEBRIS BUILDUP IN THE WATER FILTER. REPLACED DAMAGED/WORN COMPONENTS AND RECALIBRATED UNIT TO FACTORY SPECS.

    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 HANDPIECE AND THE INSERT TIP GETS VERY HOT. NO INJURY WAS REPORTED FROM THE ALLEGED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1995729 CAVITRON SELECT SPS G124 SCALER, ULTRASONIC ELC DENTSPLY LLC D003813021

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown