BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECTRODE

    MDR report key: 2448186 · Received February 3, 2012

    Report

    Report Number
    2448186
    Event Type
    Malfunction
    Date Received
    February 3, 2012
    Date of Event
    January 6, 2012
    Report Date
    February 3, 2012
    Manufacturer
    UNIMED SURGICAL PRODUCTS, INC.
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    LAPAROSCOPIC ELECTRODE INSULATION DISINTEGRATED DURING THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ELECTRODE ELECTROSURGICAL ELECTRODE GEI UNIMED SURGICAL PRODUCTS, INC. P0100 082211-09

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR