BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAVITRON INTEGRATED SYSEM BUILT IN ULTRASONIC SCALER G139

    MDR report key: 20537038 · Received October 25, 2024

    Report

    Report Number
    2424472-2024-00096
    Event Type
    Malfunction
    Date Received
    October 25, 2024
    Report Date
    December 31, 2024
    Manufacturer
    DENTSPLY LLC
    Product Code
    ELC
    UDI-DI
    D00388004021
    PMA / PMN Number
    K052334
    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

    EFZ POWER SUPPLY BOARD SHORTED. NO ACCESSORIES RECEIVED FOR EVALUATION JUST THE PLAIN MODULE. SHORTED POWER SUPPLY PCB CAUSING NO UNIT ACTIVATION. REPLACED WITH A NEW G139 DHR REVIEW IS NOT REQUIRED BECAUSE THE PRODUCT WAS RETURNED FOR EVALUATION AND THE CUSTOMER COMPLAINT IS A KNOWN HAZARD. CUSTOMER COMPLAINTS ARE MONITORED DURING MONTHLY PSC MEETINGS. THE FAILURE MODE MENTIONED IN THIS COMPLAINT IS ALSO IDENTIFIED AS A POTENTIAL HAZARD IN THE CORRESPONDING RISK MANAGEMENT FILE. THEREFORE, NO ADDITIONAL ACTION IS NECESSARY.

    Description of Event or Problem · 0

    WHILE THE CUSTOMER WAS USING A CAVITRON INTEGRATED SYSEM BUILT IN ULTRASONIC SCALER G139 THEY ALLEGE THAT MODULE, HANDPIECE AND INSERT GET HOT. NO INJURY WAS REPORTED FROM THE ALLEGED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1812370 CAVITRON INTEGRATED SYSEM BUILT IN ULTRASONIC SCALER G139 SCALER, ULTRASONIC ELC DENTSPLY LLC D00388004021

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown