BEUDAMED
    FDA Adverse Event Summary report: N

    FORCE FX

    MDR report key: 2842662 · Received October 10, 2012

    Report

    Report Number
    2842662
    Date Received
    October 10, 2012
    Date of Event
    October 5, 2012
    Report Date
    October 10, 2012
    Manufacturer
    VALLEYLAB INC.
    Product Code
    GEI
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    SURGEON STATED HE HAD 2 SMALL BURNS FROM AN ELECTROSURGICAL DEVICE. THE ELECTROSURGICAL DEVICE WAS CHECKED BY BIO-MED AND NO EQUIPMENT PROBLEM IDENTIFIED. DISPOSAL PENCIL WAS THROWN AWAY BY STAFF SO THAT COULD NOT BE CHECKED. IN THE PAST WHEN THIS OCCURRED IT WAS DUE TO USER-ERROR WITH ELECTROSURGICAL DEVICE TOUCHING HEMOSTAT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FORCE FX ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI VALLEYLAB INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR