BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAVITRON 300 SERIES G310SCLR(DNA)

    MDR report key: 21917923 · Received April 28, 2025

    Report

    Report Number
    2424472-2025-00051
    Event Type
    Malfunction
    Date Received
    April 28, 2025
    Report Date
    August 13, 2025
    Manufacturer
    DENTSPLY LLC
    Product Code
    ELC
    UDI-DI
    D00382703121
    PMA / PMN Number
    K150535
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    HPC LOT # - 05200, ST/HP LOT # - 202104. EDH. THE SIDE OF THE DISPLAY SCREEN IS CRACKED, DAMAGED QD, WH IS ALSO KINKED, RESTRICTING WATER FLOW, RUSTED USB CABLE CONNECTOR, OPEN WATER SOLENOID, CANNOT HOLD PRESSURE. DAMAGED PARTS HAVE BEEN REPLACED, THE UNIT HAVE BEEN REPAIRED, CALIBRATED AND TESTED TO FACTORY'S SPECS. NO OTHER FAULTS FOUND. DHR REVIEW IS NOT REQUIRED BECAUSE THE PRODUCT WAS RETURNED FOR EVALUATION. THE SERVICE TECHNICIAN COULD NOT REPLICATE THE FAILURE FOR OVERHEATING TIP FAILURE.

    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 300 SERIES G310, THEY ALLEGE THAT THE INSERT TIP WAS GETTING WARM. NO INJURY WAS REPORTED FROM THE ALLEGED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1428478 CAVITRON 300 SERIES G310SCLR(DNA) SCALER, ULTRASONIC ELC DENTSPLY LLC D00382703121

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown