BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAVITRON 300 SERIES G310SCLR (DNA)

    MDR report key: 19097580 · Received April 12, 2024

    Report

    Report Number
    2424472-2024-00028
    Event Type
    Malfunction
    Date Received
    April 12, 2024
    Report Date
    May 22, 2024
    Manufacturer
    DENTSPLY LLC
    Product Code
    ELC
    UDI-DI
    D00382703121
    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

    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

    WITHIN WARRANTY? NO. NOTES: "(B)(6) 2024 REPAIR TECH: (B)(6). EMV HP; CABLE, CONN/GUN CABLE OPEN. WRENCH #1 IS ILLUMINATED - NO OPERATION DUE TO AN OPEN CONDITION IN THE HANDPIECE CABLE. AS CUSTOMER'S COMPLAINING, HP IS PROPERLY DAMAGED. ADDED HP IN THE REPAIR. UPDATED LATEST VERSION OF SOFTWARE TO IMPROVE PERFORMANCE AND FIXED ALL ISSUES. HARDENED AND DETERIORATED WATER SUPPLY HOSE, DEBRIS BUILDUP IN THE WATER FILTER. REPLACED DAMAGED/WORN COMPONENTS AND RECALIBRATED UNIT TO FACTORY SPECS. QA - DS. NO HANDPIECE RECEIVED FOR EVALUATION." FOR PROPER EVALUATION PLEASE ALWAYS SEND IN ALL ACCESSORIES THAT GO ALONG WITH THE UNIT HANDPIECE # (B)(6). HANDPIECE CABLE # OLD (B)(6)-- NEW (B)(6).

    Description of Event or Problem · 0

    WHILE THE CUSTOMER WAS USING A CAVITRON 300 SERIES G310 THEY ALLEGE THAT THE HANDPIECE AND INSERT TIPS ARE OVERHEATING. NO INJURY WAS REPORTED FROM THE ALLEGED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1508584 CAVITRON 300 SERIES G310SCLR (DNA) SCALER, ULTRASONIC ELC DENTSPLY LLC D00382703121

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown