BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN GIA DST PRODUCT

    MDR report key: 1060416 · Received June 12, 2008

    Report

    Report Number
    1219930-2008-00449
    Event Type
    Injury
    Date Received
    June 12, 2008
    Date of Event
    May 8, 2008
    Report Date
    May 22, 2008
    Manufacturer
    NORTH HAVEN - USS
    Product Code
    GDW
    PMA / PMN Number
    K013860
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PROCEDURE; ILEO TAKEDOWN. ACCORDING TO THE REPORTER: NO ISSUES INTRA OPERATIVELY. THE PT EXPERIENCED A BOWEL OBSTRUCTION POST OPERATIVE. THE PT WAS REOPERATED IN '2008, AND IT WAS FOUND THAT THE STAPLER STAPLED, BUT DID NOT CUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN GIA DST PRODUCT DISPOSABLE SURGICAL STAPLER GDW NORTH HAVEN - USS

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention