BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 1963001 · Received January 5, 2011

    Report

    Report Number
    1963001
    Event Type
    Malfunction
    Date Received
    January 5, 2011
    Date of Event
    December 28, 2010
    Report Date
    January 5, 2011
    Manufacturer
    COVIDIEN VALLEYLAB
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    RI, US

    Narratives

    Description of Event or Problem · 1

    DURING A LAPAROSCOPIC APPENDECTOMY PROCEDURE, A LAPAROSCOPIC LIGASURE HANDPIECE MALFUNCTIONED; THE DEVICE WOULD GRASP THE TISSUE BUT NOT COAGULATE AND CUT THROUGH IT. THE DEVICE WAS BAGGED AND LABELED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * HAND SWITCHING INSTRUMENT GEI COVIDIEN VALLEYLAB * S9H0018

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR