BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EEA 28MM SINGLE-USE STAPLER

    MDR report key: 1081260 · Received July 23, 2008

    Report

    Report Number
    1219930-2008-00556
    Event Type
    Injury
    Date Received
    July 23, 2008
    Date of Event
    June 24, 2008
    Report Date
    July 8, 2008
    Manufacturer
    NORTH HAVEN - USS
    Product Code
    GDW
    PMA / PMN Number
    K062850
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PROCEDURE TYPE: COLORECTAL LAPAROSCOPIC ANASTOMOSIS. ACCORDING TO THE REPORTER: AFTER APPLYING THE DEVICE, ONE DONUT SPECIMEN WAS STUCK TO THE ANVIL WHILE THE OTHER WAS STUCK IN THE DEVICE. FURTHERMORE, DURING INTRA-OPERATIVE TESTING AN AIR LEAK WAS FOUND. SUBSEQUENTLY, THE SURGEON CONVERTED THE LAPAROSCOPIC PROCEDURE TO AN OPEN TO COMPLETE THE ANASTOMOSIS. SURGERY TIME WAS EXTENDED BY TWENTY AS A RESULT. THE PT IS IN WELL CURRENT CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EEA 28MM SINGLE-USE STAPLER DISPOSABLE SURGICAL STAPLER GDW NORTH HAVEN - USS U7E01

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization| R