BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GIA UNIVERSAL

    MDR report key: 1100887 · Received August 6, 2008

    Report

    Report Number
    1219930-2008-00588
    Event Type
    Injury
    Date Received
    August 6, 2008
    Date of Event
    July 29, 2008
    Report Date
    August 6, 2008
    Manufacturer
    NORTH HAVEN - USS
    Product Code
    GDW
    PMA / PMN Number
    K061095
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL REPORT SENT TO FDA ON 08/06/008.

    Description of Event or Problem · 1

    PROCEDURE: LOBECTOMY. ACCORDING TO THE REPORTER: STAPLES WOULD NOT FORM PROPERLY. TISSUE WAS RESECTED TO RE-FIRE WITH A NEW DEVICE. THE SALES REPRESENTATIVE NOTED THAT THE ANVIL BENT DURING FIRING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GIA UNIVERSAL DISPOSABLE STAPLING DEVICE GDW NORTH HAVEN - USS

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability 030414