BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO GIA ROTICULATOR 60-3.5 SULU

    MDR report key: 1901485 · Received November 11, 2010

    Report

    Report Number
    1219930-2010-00858
    Event Type
    Injury
    Date Received
    November 11, 2010
    Date of Event
    October 11, 2010
    Report Date
    October 19, 2010
    Manufacturer
    UNITED STATES SURGICAL
    Product Code
    GDW
    PMA / PMN Number
    K061095
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE: ROUX-EN-Y. ACCORDING TO THE REPORTER: ON THE THIRD FIRING DURING THE CREATION OF THE NEW GASTRIC POUCH, STAPLES DID NOT FORM. BLEEDING OCCURRED. THE SURGEON CUT OUT THE STAPLE LINE. THE CAUSE CONTINUED ON AND THE SURGEON HAD TO CREATE A SMALLER POUCH.

    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 N0J0306

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability