BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAVITRON 300 SERIES G310

    MDR report key: 17216022 · Received June 28, 2023

    Report

    Report Number
    2424472-2023-00034
    Event Type
    Malfunction
    Date Received
    June 28, 2023
    Report Date
    June 28, 2023
    Manufacturer
    DENTSPLY LLC
    Product Code
    ELC
    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. INVESTIGATION RESULTS: NOTES: 06/27/2023, REPAIR TECH: JCB. W4O WATER SOL,ISO VALVE LEAKING NO WATER FLOW DUE TO A CLOGGED WATER SOLENOID, DEBRIS BUILDUP IN THE WATER SUPPLY HOSE, DEBRIS BUILDUP IN THE WATER FILTER. REPLACED DAMAGED/WORN COMPONENTS AND RECALIBRATED UNIT TO FACTORY SPECS. ADDED NEW STACK BOARD.

    Description of Event or Problem · 0

    IN THIS EVENT IT IS REPORTED THAT CAVITRON 300 SERIES G310 OVERHEATED DURING USE, NO INJURY. INVESTIGATION FOUND THAT THERE IS NO WATER FLOW FOR THIS DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    158347 CAVITRON 300 SERIES G310 SCALER, ULTRASONIC ELC DENTSPLY LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown