BEUDAMED
    FDA Adverse Event Other Summary report: N

    ELECTROSURGICAL UNIT

    MDR report key: 603399 · Received May 10, 2005

    Report

    Report Number
    603399
    Event Type
    Other
    Date Received
    May 10, 2005
    Date of Event
    May 3, 2005
    Report Date
    May 10, 2005
    Manufacturer
    OLYMPUS AMERICA INC.
    Product Code
    GEI
    Report Source
    User Facility report
    Reporter Location
    TX, US

    Narratives

    Description of Event or Problem · 1

    WHEN THE LIVER BED WAS CAUTERIZED THERE WAS ARCING OF THE CAUTERY ELSEWHERE WITHIN THE ABDOMINAL CAVITY CAUSING AN UNNECESSARY BURN TO THE LIVER WHICH WILL BE OF NO CLINICAL SIGNIFICANCE. HOWEVER THE POTENTIAL FOR BOWEL INJURY EXISTS. THE INSTRUMENT WAS CHANGED FROM A HOOK TO A SPATULA INSTRUMENT WHICH ALSO INCLUDED A CHANGE IN THE GROUNDING SHEATH AND THE SAME ARCING OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ELECTROSURGICAL UNIT ESU GEI OLYMPUS AMERICA INC. UES-30 *

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR