BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVEREST BIPOLAR CORD

    MDR report key: 742662 · Received July 20, 2006

    Report

    Report Number
    742662
    Event Type
    Malfunction
    Date Received
    July 20, 2006
    Date of Event
    March 31, 2006
    Report Date
    July 20, 2006
    Manufacturer
    GYRUS MEDICAL, INC.
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    ME, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE PATIENT WAS PLACED ASLEEP IN THE MAIN OR FOR LAPAROSCOPY DUE TO PELVIC PAIN - POSSIBLE ECTOPIC PREGNANCY. DURING FINAL INSTRUMENT CHECK THE BIPOLAR CAUTERY WOULD NOT WORK. DECISION WAS MADE TO AWAKEN THE PATIENT AND PERFORM THE PROCEDURE IN THE MORNING WHEN EQUIPMENT COULD BE PROCURED. CLINICAL ENGINEERING INVESTIGATED EQUIPMENT AND FOUND THAT THE GYRUS ENT LLC BIPOLAR CORD EVEREST # 3998 WAS DEFECTIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EVEREST BIPOLAR CORD ESU, CORD, BIPOLAR GEI GYRUS MEDICAL, INC. 3998 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR