BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETHICON ENDO SURGERY INC.

    MDR report key: 492788 · Received October 17, 2003

    Report

    Report Number
    MW1029896
    Event Type
    Malfunction
    Date Received
    October 17, 2003
    Date of Event
    October 13, 2003
    Report Date
    October 14, 2003
    Manufacturer
    ETHICON ENDO SURGERY, INC.
    Product Code
    KOG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    STAPLING DEVICE PLACED ACROSS PULMONARY ARTERY-DEVICE DID NOT FIRE APPROPRIATELY - 2/3 OF THE ROW DID NOT FIRE. SPECIMEN SIDE OF ARTERY NOT STAPLED - SOME BLEEDING OCCURRED - CONTROLLED WITH SUTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ETHICON ENDO SURGERY INC. 1 ENDOPATH ARTICULATORY LINEAR CUTTER ETS FLEX 45 ENDOSCOPIC KOG ETHICON ENDO SURGERY, INC. ATW 45 45MM VASCULAR/THIN *

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other