BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EGIA 60 ARTICULATING MED/THICK SULU

    MDR report key: 2032590 · Received March 22, 2011

    Report

    Report Number
    1219930-2011-00228
    Event Type
    Injury
    Date Received
    March 22, 2011
    Date of Event
    March 17, 2011
    Report Date
    March 17, 2011
    Manufacturer
    UNITED STATES SURGICAL
    Product Code
    GDW
    PMA / PMN Number
    K083519
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE: PANCREAS LEFT RESECTION. ACCORDING TO THE REPORTER: DURING THE CUT OF THE PANCREAS TAIL THE MAGAZINE COULD NOT BE OPENED ANYMORE AFTER FIRING. BUT THE PUT-BACK-BAR OF THE GIA UNIVERSAL HANDLE COULD BE REMOVED. THE MAGAZINE WAS REMOVED FROM THE TISSUE WITH ELECTRICITY. EXTENSION OF SURGERY TIME WAS REPORTED AS MORE THAN 30 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EGIA 60 ARTICULATING MED/THICK SULU DISPOSABLE STAPLER GDW UNITED STATES SURGICAL N1A0448UL

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability