BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EGIA ULTRA UNIVERSAL STAPLER

    MDR report key: 3853535 · Received June 3, 2014

    Report

    Report Number
    2647580-2014-00399
    Event Type
    Injury
    Date Received
    June 3, 2014
    Date of Event
    May 6, 2014
    Report Date
    May 9, 2014
    Manufacturer
    COVIDIEN, USSC PUERTO RICO, INC.
    Product Code
    GDW
    PMA / PMN Number
    K083519
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER: THE CUSTOMER REPORTS THAT DURING USE THE DEVICE STAPLED BUT COULD NOT BE REOPENED. THE SURGEON CLAMPED THE TISSUE AND USED A BISTOURY TO FREE THE DEVICE. VISUALLY THE DEVICE SEEMED FINE BUT ON INSPECTION A SMALL PIECE OF METAL CAME OUT OF THE INSTRUMENT (OUTSIDE THE PATIENT'S CAVITY). IT LOOKED LIKE A SMALL PIN WHICH SEEMED TO BE LINKED TO A SPRING. 600CC BLOOD LOSS DUE TO THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323231 EGIA ULTRA UNIVERSAL STAPLER DISPOSABLE SURGICAL STAPLER GDW COVIDIEN, USSC PUERTO RICO, INC. P4A0327X

    Patients

    Seq Age Sex Outcome Treatment
    1 LOT NUMBER N2G0207ULX, EXP DATE:07/31/2017,| EGIA 45 ARTICULATING VAS/MED SULU: EGIA45AVM,| MFR DATE: 07/2012, K083519