BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EGIA ULTRA UNIVERSAL SHORT STAPLER

    MDR report key: 2250059 · Received September 9, 2011

    Report

    Report Number
    1219930-2011-00773
    Event Type
    Injury
    Date Received
    September 9, 2011
    Date of Event
    August 25, 2011
    Report Date
    August 26, 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: PROXIMAL PANCREATICODUODENECTOMY. ACCORDING TO THE REPORTER: WHEN APPROACHED ON DUODENUM, THE JAWS WOULD NOT CLOSE TIGHT ENOUGH. IT WAS FORCED CLOSED AND FIRING WAS DONE, BUT A BROKEN SOUND WAS HEARD. MOREOVER, FIRING WAS NOT COMPLETED. ADDITIONAL RESECTION OF TISSUE WAS NEEDED. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO BLEEDING OCCURRED. NOTHING FELL INTO THE PATIENT CAVITY. OPERATIVE TIME WAS NOT EXTENDED MORE THAN 30 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EGIA ULTRA UNIVERSAL SHORT STAPLER DISPOSABLE SURGICAL STAPLING DEVICE GDW UNITED STATES SURGICAL N1E0811UKX

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability EGIA 60 ARTICULATING MED/THICK SULU:| EXP: 05/31/2016, MANUF: 05/2011, (B)(4)| CATALOG #: EGIA60AMT, LOT# N1E0481UL