BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EGIA ULTRA UNIVERSAL SHORT STAPLER

    MDR report key: 2210029 · Received August 2, 2011

    Report

    Report Number
    1219930-2011-00638
    Event Type
    Injury
    Date Received
    August 2, 2011
    Date of Event
    July 20, 2011
    Report Date
    July 20, 2011
    Manufacturer
    UNITED STATES SURGICAL A
    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: THE ARTICULATING LEVER WAS INFLECTED 2 DEGREES AND ATTACHED TO THE TISSUE. ON 3RD TIME OF SQUEEZING, THE HANDLE FELT HEAVY AND BROKEN SOUND WAS HEARD. THE HANDLE COULD BE FULLY SQUEEZED. IT WAS FOUND MALFORMED STAPLING OCCURRED FROM THE TIP TO THE MIDDLE OF THE STAPLE LINE. WHEN THE DEVICE WAS CHECKED, IT WAS FOUND THAT THE JAWS WERE SLIGHTLY OPEN. WHEN THE ANVIL WAS CHECKED, A PIECE OF METAL WAS FOUND 2CM FROM THE ANVIL ROOT. IT MIGHT BE A PIECE OF THE KNIFE BAR. THE TISSUE WAS NOT TOO THICK. THE TISSUE WAS CUT BY (B)(4) ADDITIONALLY AND ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. BLEEDING UNDER 200CC OCCURRED. NOTHING FELL INTO THE PATIENT CAVITY. OPERATIVE TIME WAS EXTENDED MORE THAN 30 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EGIA ULTRA UNIVERSAL SHORT STAPLER DISPOSABLE STAPLER GDW UNITED STATES SURGICAL A N1D0833UK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other EXP. 06/30/2016, (B)(4)| EGIA 60 ARTICULATING MED/THICK SULU:| CATALOG # EGIA60AMT, LOT N1E0733UL, MANUF: 06/2011