BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EEA 31MM SINGLE-USE STAPLER

    MDR report key: 3191283 · Received June 13, 2013

    Report

    Report Number
    2647580-2013-00334
    Event Type
    Injury
    Date Received
    June 13, 2013
    Date of Event
    May 23, 2013
    Report Date
    May 24, 2013
    Manufacturer
    COVIDIEN, FORMERLY USSC PUERTO RICO
    Product Code
    GDW
    PMA / PMN Number
    K062850
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE: ANTERIOR RESECTION. ACCORDING TO THE REPORTER, AFTER FIRING THE SURGEON TURNED THE WINGNUT AND TRIED TO REMOVE THE DEVICE, BUT IT WAS DIFFICULT TO REMOVE. THE TISSUE SEEMED TO BE CAUGHT BETWEEN THE ANVIL AND THE STAPLER, AND THE ANASTOMOSED PART WAS TORN. THE PROCEDURE WAS CONVERTED INTO OPEN AND THE TORN PART WAS SUTURED MANUALLY. THERE WAS TISSUE DAMAGE AND UNANTICIPATED TISSUE LOSS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    270637 EEA 31MM SINGLE-USE STAPLER DISPOSABLE SURGICAL STAPLING DEVICE GDW COVIDIEN, FORMERLY USSC PUERTO RICO P2J0338X

    Patients

    Seq Age Sex Outcome Treatment
    1 Other