BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO GIA ROTICULATOR 45-4.8 SULU

    MDR report key: 1192438 · Received October 7, 2008

    Report

    Report Number
    1219930-2008-00732
    Event Type
    Injury
    Date Received
    October 7, 2008
    Date of Event
    September 8, 2008
    Report Date
    September 9, 2008
    Manufacturer
    NORTH HAVEN - USS
    Product Code
    GDW
    PMA / PMN Number
    K061095
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PROCEDURE: LOW ANTERIOR RESECTION. ACCORDING TO THE REPORTER: THE FIRST APPLICATION ON THE COLON LOW IN PELVIS WAS FIRED BUT THE SURGEON WAS NOT ABLE TO RETRACT THE LOAD AND OPEN. THE PROCEDURE WAS CONVERTED TO LAPAROTOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDO GIA ROTICULATOR 45-4.8 SULU DISPOSABLE STAPLING DEVICE GDW NORTH HAVEN - USS

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention 030449