BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAVITRON 300 SERIES G310SCLR

    MDR report key: 17070695 · Received June 6, 2023

    Report

    Report Number
    2424472-2023-00030
    Event Type
    Malfunction
    Date Received
    June 6, 2023
    Report Date
    June 6, 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. THE DEVICE EVALUATED. EVALUATION RESULTS: SAK 000 UNIT RECEIVED WITH WATER FLOW TURNED OFF AT HP FLOW CONTROL, RAN UNIT FOR EXTENDED PERIOD WITH FSI-10 INSERT,WATER FLOW SET AT 35 CC/MIN AT MAXIMUM POWER AND FOUND NO ISSUES WITH HP HEATING AS ALLEDGED, CUSTOMER MAY HAVE CLOGGED/DAMAGED INSERTS OR IS USING DIFFERENT MANUFACTURER'S INSERTS, UNIT MEETS SPECIFICATIONS. QA-RB.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    697060 CAVITRON 300 SERIES G310SCLR SCALER, ULTRASONIC ELC DENTSPLY LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown