BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVEREST BIPOLAR BICOAG

    MDR report key: 1053108 · Received May 16, 2008

    Report

    Report Number
    1053108
    Event Type
    Malfunction
    Date Received
    May 16, 2008
    Date of Event
    May 12, 2008
    Report Date
    May 16, 2008
    Manufacturer
    GYRUS MEDICAL, INC.
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE PHYSICIAN WAS USING THE EVEREST BIPOLAR CUTTING FORCEPS WHEN IT WAS NOTED TO BE BURNING THE TISSUE, AND ALSO STICKING TO THE TISSUE AND RIPPING IT. THE DEVICE WAS CLEANED BY THE SCRUB NURSE WITH NO IMPROVEMENT. THE PROCEDURE WAS STOPPED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EVEREST BIPOLAR BICOAG FORCEPS, ESU GEI GYRUS MEDICAL, INC. 3005 5MM, 33CM 7352014

    Patients

    Seq Age Sex Outcome Treatment
    1 *