BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EEA 28MM SINGLE-USE STAPLER

    MDR report key: 4071282 · Received September 5, 2014

    Report

    Report Number
    2647580-2014-00746
    Event Type
    Injury
    Date Received
    September 5, 2014
    Date of Event
    July 28, 2014
    Report Date
    August 28, 2014
    Manufacturer
    COVIDIEN, FORMERLY USSC PUERTO RICO, INC.
    Product Code
    GDW
    PMA / PMN Number
    K062850
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: COLOSTOMY TAKEDOWN. ACCORDING TO THE REPORTER: SEVERAL DAYS AFTER THE PROCEDURE, THE PT WAS BROUGHT BACK INTO THE OPERATING ROOM FOR A SUSPECTED LEAK AT THE ANASTOMOSIS SITE. THERE WAS A POST OPERATIVE LEAK. A COLOSTOMY WAS PERFORMED AND THE SURGEON WAS ABLE TO VISUALLY INSPECT THE STAPLE LINES WITH THE SIGMOID-SCOPE. THE STAPLE LINE WAS COMPLETE AND HAD PROPERLY FORMED STAPLES. THERE WAS UNANTICIPATED TISSUE LOSS. THERE WAS NO UNANTICIPATED BLOOD LOSS OF MORE THAN 500CC. THERE WAS NO DELAY OVER 30 MINS IN SURGERY TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    543571 EEA 28MM SINGLE-USE STAPLER DISPOSABLE SURGICAL STAPLING DEVICE GDW COVIDIEN, FORMERLY USSC PUERTO RICO, INC. NOT AVAIILABLE

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other