BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GYRUS, PK-SP GENERATOR

    MDR report key: 19138641 · Received April 18, 2024

    Report

    Report Number
    3011050570-2024-00135
    Event Type
    Malfunction
    Date Received
    April 18, 2024
    Report Date
    April 18, 2024
    Manufacturer
    GYRUS ACMI, INC.
    Product Code
    GEI
    PMA / PMN Number
    K031085
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE EVALUATION FOUND THE POWER SUPPLY UNIT (PSU) OUTPUT WAS NOT STABLE AND FAILED THE PULSE WIDTH MODULATION (PWM) ADJUSTMENT. THE PSU BOARD WAS REPLACED. A DEFINITIVE ROOT CAUSE IS UNABLE TO BE DETERMINED FOR THIS COMPLAINT. THE ROOT CAUSE OF THE PSU OUTPUT BEING UNSTABLE IS DUE TO THE PSU BOARD BECOMING FAULTY, BUT THE ROOT CAUSE OF THE PSU BOARD FAULTING IS NOT KNOWN. OLYMPUS WILL CONTINUE TO MONITOR THE FIELD PERFORMANCE OF THIS DEVICE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE ELECTROSURGICAL GENERATOR EXHIBITED THE POWER SUPPLY UNIT (PSU) OUTPUT WAS NOT STABLE AND FAILED THE PULSE WIDTH MODULATION (PWM) ADJUSTMENT. THE PRINTED CIRCUIT BOARD WAS REPLACED. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2589820 GYRUS, PK-SP GENERATOR ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI GYRUS ACMI, INC. 744000

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown