BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EEA 28MM SINGLE-USE STAPLER

    MDR report key: 2221286 · Received August 17, 2011

    Report

    Report Number
    2647580-2011-00545
    Event Type
    Injury
    Date Received
    August 17, 2011
    Date of Event
    July 25, 2011
    Report Date
    July 25, 2011
    Manufacturer
    USSC PUERTO RICO
    Product Code
    GDW
    PMA / PMN Number
    K062850
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: SIGMOID RESECTION. ACCORDING TO THE REPORTER: THE DEVICE FIRED WITH NO ABNORMALITIES. WHEN OPENING, THE SURGEON DID NOT FEEL A CLICK. WHEN REMOVING, THE ANVIL DETACHED. RING FORCEPS WERE USED ANALLY TO REMOVE THE ANVIL. WHEN GRASPED, THE SURGEON REALIZED THAT THE ANVIL WAS STUCK ON THE ANTERIOR LIP OF THE ANASTOMOSIS. AFTER A FORCED REMOVAL, THE SURGEON IDENTIFIED A DIME SIZED HOLE ON THE ANTERIOR PORTION OF THE ANASTOMOSIS AND HAD TO SUTURE IT CLOSED LAPAROSCOPICALLY. THERE WAS A 30-40 MINUTE DELAY IN THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EEA 28MM SINGLE-USE STAPLER DISPOSABLE SURGICAL STAPLING DEVICE GDW USSC PUERTO RICO P1F0643H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention