BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAPR- CLIP 12MM LPW

    MDR report key: 1321075 · Received February 19, 2009

    Report

    Report Number
    1219930-2009-00113
    Event Type
    Injury
    Date Received
    February 19, 2009
    Date of Event
    January 9, 2009
    Report Date
    February 11, 2009
    Manufacturer
    NORTH HAVEN - USS
    Product Code
    GDO
    PMA / PMN Number
    K925602
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PROCEDURE TYPE: COLECTOMY. ACCORDING TO THE REPORTER: THE CLIP REMAINED JAMMED ON THE BLACK ANVIL AND WAS DIFFICULT TO REMOVE WITHOUT DAMAGING THE VESSEL. THE VESSEL WAS DAMAGED WHILE REMOVING THE DEVICE. A NEW INSTRUMENT WAS USED TO COMPLETE THE PROCEDURE. NO DELAY TO SURGERY AND NO BLOOD LOSS WERE REPORTED. THE PT IS IN WELL CURRENT CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAPR- CLIP 12MM LPW DISPOSABLE SURGICAL CLIP APPLIER GDO NORTH HAVEN - USS N8J238

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R