BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAVITRON 300 SERIES G310SCLR(DNA)

    MDR report key: 19281788 · Received May 9, 2024

    Report

    Report Number
    2424472-2024-00038
    Event Type
    Malfunction
    Date Received
    May 9, 2024
    Report Date
    June 10, 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

    SAK EMH FOUND HPC WATER FLOW COMING APART, REPLACED DAMAGED HPC WITH NEW. CUSTOMER ALSO STATES FOOT PADDLE STEP ON, YELLOW LIGHT SHOW ON THE CAVITRON. FOOT CONTROL IS A TWO POSITION FOOT CONTROL 1ST POSITION AND SECOND POSITION, WHEN COMPLETELY PRESSED LED WILL TURN FROM GREEN TO YELLOW INDICATION 2ND POSITION, THIS IS NORMAL, REFER TO USER MANUAL. VERIFIED TUNING/CALIBRATION AND TESTED ALL FUNCTIONS QA-IS. HPC 10230. NO STERIMATE, POWER SUPPLY OR POWER CORD WITH UNIT.

    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 UNIT AND THE INSERT TIPS GET HOT. NO INJURY WAS REPORTED FROM THE ALLEGED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1547717 CAVITRON 300 SERIES G310SCLR(DNA) SCALER, ULTRASONIC ELC DENTSPLY LLC D00382703111

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown