BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GIA UNIVERSAL

    MDR report key: 1092564 · Received August 1, 2008

    Report

    Report Number
    1219930-2008-00576
    Event Type
    Injury
    Date Received
    August 1, 2008
    Date of Event
    July 26, 2008
    Report Date
    July 29, 2008
    Manufacturer
    NORTH HAVEN-USS
    Product Code
    GDW
    PMA / PMN Number
    K061095
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL REPORT SENT TO FDA ON 7/31/08.

    Description of Event or Problem · 1

    PROCEDURE: LUNG RESECTION. ACCORDING TO THE REPORTER: LEFT LOWER LOBE. UPON FIRING OVER LOBAR BRONCHUS, MALFORMED STAPLES WERE STUCK IN THE SULU AND WOULD NOT ALLOW INSTRUMENT TO RELEASE FROM TISSUE. TISSUE WAS RESECTED WITH ANOTHER STAPLER. PT STATUS REPORTED AS OK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GIA UNIVERSAL DISPOSABLE STAPLING DEVICE GDW NORTH HAVEN-USS N8D443

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability 030452| EXPIRATION DATE: 04/30/2013| MANUFACTURE DATE: 04/01/2008| ENDO GIA ROTICULATOR 30-3.5 SULU| LOT N8D51