BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DST SERIES EEA ORVIL 25MM DEVICE

    MDR report key: 1221918 · Received November 4, 2008

    Report

    Report Number
    1219930-2008-00801
    Event Type
    Injury
    Date Received
    November 4, 2008
    Date of Event
    October 14, 2008
    Report Date
    October 14, 2008
    Manufacturer
    NORTH HAVEN - USS
    Product Code
    GDW
    PMA / PMN Number
    K062850
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PROCEDURE TYPE: GASTRECTOMY: POST LAP BAND REMOVAL. ACCORDING TO THE REPORTER: THE VISUALIZATION WAS DIFFICULT AND THE ANVIL WAS DIFFICULT TO MATE TO THE INSTRUMENT SHAFT. ONCE THE ANVIL WAS ATTACHED TO THE INSTRUMENT THE HANDLES CLOSED, ANVIL TILTED AND IT WOULD NOT CLOSE PROPERLY. SURGEON REMOVED THE DEVICE AND SEWED THE ANASTOMOSIS ADDING TWENTY MINUTES TO CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DST SERIES EEA ORVIL 25MM DEVICE DISPOSABLE SURGICAL STAPLER GDW NORTH HAVEN - USS U7E07

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention EEA XL 25MM STAPLER WITH 3.5MM STAPLES| PRODUCT