BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETHICON ENDO SURGERY LLC

    MDR report key: 2916369 · Received January 9, 2013

    Report

    Report Number
    MW5028582
    Event Type
    Malfunction
    Date Received
    January 9, 2013
    Date of Event
    November 13, 2012
    Report Date
    January 9, 2013
    Manufacturer
    ETHICON ENDOSURGERY LLC
    Product Code
    GDW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A (B)(6) FEMALE ADMITTED FOR ELECTIVE LAP SLEEVE GASTRECTOMY DONE BY (B)(6) MD. ACCORDING TO THE EVENT REPORT "THE INSTRUMENT MISFIRES - STICKS WHEN CLOSED. UNABLE TO OPEN JAWS". THERE WAS NO HARM TO THE PT AND SHE WAS DISCHARGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    12787 ETHICON ENDO SURGERY LLC ECHELON FLEX 60 LONG ARTICULATING ENDOSCOPIC LINEAR GDW ETHICON ENDOSURGERY LLC P30188P05 J4CF8J

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR