BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EGIA 60 ARTICULATING MED-THICK SULU

    MDR report key: 2202431 · Received August 5, 2011

    Report

    Report Number
    1219930-2011-00657
    Event Type
    Injury
    Date Received
    August 5, 2011
    Date of Event
    July 20, 2011
    Report Date
    July 21, 2011
    Manufacturer
    UNITED STATES SURGICAL
    Product Code
    GDW
    PMA / PMN Number
    K083519
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: LAPAROSCOPIC RECTUM RESECTION. ACCORDING TO THE REPORTER: THE HANDLE STOPPED IN THE MIDDLE. BROKEN SOUND WAS ALSO HEARD. THE DEVICE WAS RELEASED IN THE MIDDLE OF RECTUM. ADDITIONAL RESECTION OF TISSUE WAS DONE WITH ECHELON GREEN AND ANASTOMOSIS WAS DONE. A METAL PIECE WAS FOUND ON THE KNIFE TRACK ON THE CARTRIDGE. NO BLEEDING OCCURRED. NOTHING FELL INTO THE PT CAVITY. OPERATIVE TIME WAS NOT EXTENDED MORE THAN 30 MINUTES.

    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 N1F0443ULX

    Patients

    Seq Age Sex Outcome Treatment
    1 Other LOT: N1C0651UK, K083519| MANUF: 03/2011, EXP: 03/31/2016| EGIA ULTRA UNIVERSAL STAPLER: CATALOG#: EGIAUSTND