BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EGIA ULTRA UNIVERSAL STAPLER

    MDR report key: 3926337 · Received July 1, 2014

    Report

    Report Number
    2647580-2014-00487
    Event Type
    Injury
    Date Received
    July 1, 2014
    Date of Event
    June 4, 2014
    Report Date
    June 5, 2014
    Manufacturer
    COVIDIEN
    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

    PROCEDURE: LAPAROTOMY FOR DEEP ENDOMETRIOSIS. ACCORDING TO THE REPORTER: THE CUSTOMER REPORTS THAT WHEN THE SURGEON TRIED TO CUT THE RECTUM IN ORDER TO RELEASE THE OPERATIVE PIECE, THE DEVICE BROKE AT THE CONNECTION SITE STAPLER/SULU. A COVIDIEN STAPLER WAS USED TO RESECT THE BROKEN RELOAD AND THE TISSUE IN THE JAWS OF THE BROKEN SULU. NO REINFORCEMENT MATERIAL WAS USED IN CONJUNCTION WITH THE STAPLING DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    383615 EGIA ULTRA UNIVERSAL STAPLER DISPOSABLE SURGICAL STAPLER GDW COVIDIEN P4C0062X

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Disability EXP DATE: 09/30/2018,| EGIA 45 ARTICULATING MED/THICK SULU: (B)(4),| LOT# N3J0318ULX,| MFG DATE: 09/2013