BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO GIA ROTICULATOR 45-3.5 SULU

    MDR report key: 2070920 · Received April 19, 2011

    Report

    Report Number
    1219930-2011-00306
    Event Type
    Injury
    Date Received
    April 19, 2011
    Report Date
    April 10, 2011
    Manufacturer
    UNITED STATES SURGICAL
    Product Code
    GDW
    PMA / PMN Number
    K061095
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER: THE STAPLER WASN'T BEEN FIRED CORRECTLY. IT HAD BAD "B" SHAPE. THERE WAS SOME FLUID LEAKAGE. THE SURGEON STAPLED AND OVER SEWED OVER THE PREVIOUS BAD STAPLING LINE WHICH RESULTED IN ADDITIONAL TISSUE LOSS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDO GIA ROTICULATOR 45-3.5 SULU DISPOSABLE STAPLER GDW UNITED STATES SURGICAL N9A08

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability