BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EGIA 60 ARTICULATING MED/THICK SULU

    MDR report key: 1900108 · Received November 9, 2010

    Report

    Report Number
    1219930-2010-00838
    Event Type
    Injury
    Date Received
    November 9, 2010
    Date of Event
    October 11, 2010
    Report Date
    October 13, 2010
    Manufacturer
    UNITED STATES SURGICAL
    Product Code
    GDW
    PMA / PMN Number
    K061095
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE: GASTRECTOMY. ACCORDING TO THE REPORTER: THE STAPLE LINE WAS INTACT, BUT THERE WAS A SEROSAL TEAR. THE SURGEON FIRED A SECOND LOAD JUST PROXIMAL TO THE FIRST FIRE AND IT WORKED FINE. HE USED A WOUND RETRACTOR TO REMOVE SPECIMEN AND WHEN HE DID, HE REPAIRED THE SEROSAL TEAR WITH SUTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EGIA 60 ARTICULATING MED/THICK SULU DISPOSABLE STAPLER GDW UNITED STATES SURGICAL N0E0489UL

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention