BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EGIA 60 ARTICULATING MED/THICK SULU

    MDR report key: 2210032 · Received August 2, 2011

    Report

    Report Number
    1219930-2011-00639
    Event Type
    Injury
    Date Received
    August 2, 2011
    Date of Event
    July 20, 2011
    Report Date
    July 20, 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 TYPE: GASTRECTOMY. ACCORDING TO THE RPTR: THE MAGAZINE COULD NOT BE OPENED ANYMORE AFTER FIRING. THE FIRST MAGAZINE WAS OPENED WITH GREAT FORCE, THE SECOND MAGAZINE WAS CUT OUT AND WAS GIVEN WITH THE TISSUE TO THE PATHOLOGY FOR FLASH TEST. THE YELLOW PRE-RELEASE SAFEGUARD WAS NOT REMOVED AT THE CONNECTION WITH THE HANDLE. NEW MAGAZINES AND HANDLES WERE USED TO FINISH OPERATION. NO PERSONS WERE INJURED. OPERATIVE TIME WAS EXTENDED BY MORE THAN 30 MIN. NO BLOOD LOSS OCCURRED. THERE WAS NO EXTENSION OF THE INCISION, AND NO CHANGE OF OPERATION. A SMALL PIECE OF TISSUE WAS LOST WHEN THE SECOND MAGAZINE WAS CUT OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EGIA 60 ARTICULATING MED/THICK SULU DISPOSABLE SURGICAL STAPLING DEVICE GDW UNITED STATES SURGICAL N1E0828UL

    Patients

    Seq Age Sex Outcome Treatment
    1 Other