BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EEA 31MM SINGLE-USE STAPLER

    MDR report key: 3170369 · Received June 7, 2013

    Report

    Report Number
    2647580-2013-00315
    Event Type
    Injury
    Date Received
    June 7, 2013
    Date of Event
    May 17, 2013
    Report Date
    May 20, 2013
    Manufacturer
    COVIDIEN, FORMERLY USSC
    Product Code
    GDW
    PMA / PMN Number
    K062850
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE: LOW ANTERIOR RESECTION. ACCORDING TO THE REPORTER: THE ANVIL WAS PLACED PROXIMAL TO THE COLON WITH THE PURSTRING. THE RECTUM WAS STAPLED WITH A TA STAPLER. THE EEA WAS INTRODUCED TRANSANALLY, OPENED THE CENTER ROD THROUGH THE STAPLE LINE AND CONNECTED TO THE ANVIL. CLOSED THE STAPLER UNTIL GREEN WAS SEEN IN THE WINDOW AND FIRED THE STAPLER. UPON REMOVING THE STAPLER, THE ANVIL WAS NOT ATTACHED. SURGEON NOTICED THAT STAPLED AREA WAS ALL APART AND THERE WERE UNFORMED STAPLES. A NEW DEVICE WAS OPENED, RE-APPLIED THE STAPLER AND EVERYTHING WENT FINE. THE CASE WAS DELAYED MORE THAN 30 MINUTES. UNANTICIPATED TISSUE LOSS OCCURRED. NO BLOOD LOSS GREATER THAN 500CC WAS REPORTED. NO REINFORCEMENT MATERIAL WAS USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253530 EEA 31MM SINGLE-USE STAPLER DISPOSABLE STAPLING DEVICE GDW COVIDIEN, FORMERLY USSC P1M0028H

    Patients

    Seq Age Sex Outcome Treatment
    1 Other