BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CIRCULAR STAPLER, 29MM DIGITAL LOADING UNIT

    MDR report key: 1180213 · Received September 29, 2008

    Report

    Report Number
    2532140-2008-00083
    Event Type
    Injury
    Date Received
    September 29, 2008
    Date of Event
    September 18, 2008
    Report Date
    September 18, 2008
    Manufacturer
    POWER MEDICAL INTERVENTIONS
    Product Code
    GDW
    PMA / PMN Number
    K032701
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS DISCARDED BY USER AS THE LEAK DEVELOPED DAYS AFTER THE SURGERY, AND THEREFORE COULD NOT BE RETURNED FOR INVESTIGATION.

    Description of Event or Problem · 1

    A CS29 DEVICE WAS USED IN SURGERY ON A PRIOR DATE. THEY STATED THAT THE PT WAS SENT BACK TO THE O.R FOR LEAK REPAIR AND ILEOSTOMY. THE SURGEON MENTIONED THAT IN THE RE-OPERATIVE PROCEDURE, HE VISUALIZED THAT THE LEAK WAS IN THE ANASTOMOTIC STAPLE LINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CIRCULAR STAPLER, 29MM DIGITAL LOADING UNIT STAPLE, IMPLANTABLE GDW POWER MEDICAL INTERVENTIONS UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention