BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAVITRON 300 SERIES G310SCLR(DNA)

    MDR report key: 21264327 · Received January 29, 2025

    Report

    Report Number
    2424472-2025-00012
    Event Type
    Malfunction
    Date Received
    January 29, 2025
    Report Date
    April 7, 2025
    Manufacturer
    DENTSPLY LLC
    Product Code
    ELC
    UDI-DI
    D00382703111
    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

    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

    HPC LOT # - 03190. ST LOT # - 202303. EDH DSP/IF/IC/SCAN BOARD DAMAGED. THE SIDES OF THE DISPLAY SCREEN IS CRACKED, DAMAGED SOLENOID, CANNOT REGULATE WATER FLOW BUILT UP DEBRIS IN THE HPC HARNESS, DEBRIS IN THE WATER FILTER. CHECK THE CALIBRATIONS THE UNIT WILL BE REPAIRED UPON ESTIMATES APPROVAL. THE HPC HOLDER IS BURNT. DHR REVIEW IS NOT REQUIRED BECAUSE THE PRODUCT WAS RETURNED FOR EVALUATION AND THE DESCRIBED FAILURE MODE IS A KNOWN HAZARD.

    Description of Event or Problem · 0

    WHILE USING A CAVITRON 300 SERIES G310 THEY ALLEGE THAT THE HANDPIECE OVERHEATED, MELTED THE CRADLE WITH THE INSERT IN IT, AND THE WATER LEAKING OUT THE BACK OF THE UNIT, THEY SMELLED IT GETTING HOT, NO INJURY RESULTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1819145 CAVITRON 300 SERIES G310SCLR(DNA) SCALER, ULTRASONIC ELC DENTSPLY LLC D00382703111

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown