BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETHICON ENDO-SURGERY, INC.

    MDR report key: 853199 · Received May 18, 2007

    Report

    Report Number
    MW5001889
    Event Type
    Malfunction
    Date Received
    May 18, 2007
    Date of Event
    April 30, 2007
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    KOG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    ME, US

    Narratives

    Description of Event or Problem · 1

    PROCEDURE= LEFT HEMICOLECTOMY; STAPLES DID NOT FIRE IN A COMPLETE CIRCLE OR DID NOT CLOSE ALL THE WAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ETHICON ENDO-SURGERY, INC. CURVED INTRALUMINAL STAPLER KOG ETHICON ENDO-SURGERY, INC. 1 PROXIMATE ILS T4W437

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR