BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAVITRON 300 SERIES G310SCLR(DNA)

    MDR report key: 20383069 · Received October 7, 2024

    Report

    Report Number
    2424472-2024-00089
    Event Type
    Malfunction
    Date Received
    October 7, 2024
    Report Date
    November 15, 2024
    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

    (B)(6) 2024 REPAIR TECH: (B)(4). E1H PROBE,INNER MODULE,HP DAMAGED. INSERT WAS STUCK IN THE STERIMATE, BACK OF STERIMATE WAS SEPARATED. TOUCHSCREEN LAG. DEBRIS BUILDUP IN THE HANDPIECE CABLE. DEBRIS BUILDUP IN THE WATER FILTER. REPLACED DAMAGED/WORN COMPONENTS AND RECALIBRATED UNIT TO FACTORY SPECS. NO POWER CORD RECEIVED FOR EVALUATION." QA -DS. HANDPIECE # : OLD 202308 -- NEW 202408. HANDPIECE CABLE # : OLD 07200 -- NEW 07240.

    Description of Event or Problem · 0

    WHILE USING A CAVITRON 300 SERIES G310, THEY ALLEGE THAT THEY HAVE LOW WATER FLOW AND A HOT HANDPIECE, NO INJURY RESULTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2543474 CAVITRON 300 SERIES G310SCLR(DNA) SCALER, ULTRASONIC ELC DENTSPLY LLC D00382703111

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown