BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO GIA ROTICULATOR 30-2.5 SULU

    MDR report key: 3011007 · Received March 11, 2013

    Report

    Report Number
    1219930-2013-00197
    Event Type
    Injury
    Date Received
    March 11, 2013
    Date of Event
    January 14, 2013
    Report Date
    February 13, 2013
    Manufacturer
    COVIDIEN, FORMERLY US SUR
    Product Code
    GDW
    PMA / PMN Number
    K061095
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: PANCREATECTOMY. ACCORDING TO THE REPORTER: THE DEVICE WAS APPLIED ON A MAJOR PANCREATIC VEIN. THE CARTRIDGE JAMMED ON THE VEIN AND DESPITE ALL EFFORTS, INSTRUMENT COULD NOT OPEN. TRIED ANOTHER ENDO GIA HANDLE BUT IT DID NOT WORK. THE SURGEON RESECTED THE DEVICE AND ATTACHED THE VEIN ON BOTH SIDES OF THE CARTRIDGE. A PART OF THE VEIN IS STILL IN THE BLOCKED CARTRIDGE. THE CASE WAS EXTENDED BY MORE THAN 30 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    102531 ENDO GIA ROTICULATOR 30-2.5 SULU DISPOSABLE SURGICAL STAPLING DEVICE GDW COVIDIEN, FORMERLY US SUR N0M0638L

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability