BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO GIA ROTICULATOR 60-3.5 SULU

    MDR report key: 1915755 · Received November 29, 2010

    Report

    Report Number
    1219930-2010-00900
    Event Type
    Injury
    Date Received
    November 29, 2010
    Date of Event
    November 17, 2010
    Report Date
    November 17, 2010
    Manufacturer
    UNITED STATES SURGICAL
    Product Code
    GDW
    PMA / PMN Number
    K061095
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE: LAP. TOTAL GASTRECTOMY. ACCORDING TO THE REPORTER: STAPLES DID NOT FORM PROPERLY. SURGERY TIME EXTENSION WAS REPORTED AS MORE THAN MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDO GIA ROTICULATOR 60-3.5 SULU DISPOSABLE STAPLER GDW UNITED STATES SURGICAL N0F0328

    Patients

    Seq Age Sex Outcome Treatment
    1 Other