BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EEA 28MM SINGLE-USE STAPLER

    MDR report key: 3170071 · Received June 4, 2013

    Report

    Report Number
    2647580-2013-00308
    Event Type
    Injury
    Date Received
    June 4, 2013
    Report Date
    May 12, 2013
    Manufacturer
    COVIDIEN
    Product Code
    GDW
    PMA / PMN Number
    K062850
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE: COLOSTOMY TAKEDOWN. ACCORDING TO THE REPORTER: AFTER FIRING THE INSTRUMENT, THE SURGEON TURNED THE KNOB TWO FULL TURNS COUNTER CLOCKWISE TO OPEN THE INSTRUMENT. WHEN TRYING TO REMOVE THE STAPLER FROM THE RECTUM, THE ANVIL WAS STUCK AND SEPARATED FROM THE STAPLER HANDLE. AS A RESULT THE SURGEON HAD TO CONVERT FROM LAP TO OPEN PROCEDURE TO OPEN THE COLON AND REMOVE THE ANVIL. WHEN SURGEON INSPECTED THE ANASTOMOSIS IT SHOWED NO LEAKAGE, AND WHEN INSPECTING THE DONUTS, BOTH SEEMED FINE. THERE WAS NO BLOOD LOSS OF 500CC OR MORE DUE TO THE PRODUCT PROBLEM. OPERATIVE TIME WAS EXTENDED BY MORE THAN 30 MINUTES DUE TO THE PRODUCT PROBLEM. THERE WAS NO UNANTICIPATED TISSUE LOSS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    247548 EEA 28MM SINGLE-USE STAPLER DISPOSABLE SURGICAL STAPLER GDW COVIDIEN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R