BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAPR-CLIP 12MM LPW

    MDR report key: 1802563 · Received August 10, 2010

    Report

    Report Number
    1219930-2010-00618
    Event Type
    Injury
    Date Received
    August 10, 2010
    Date of Event
    August 4, 2010
    Report Date
    August 9, 2010
    Manufacturer
    UNITED STATES SURGICAL
    Product Code
    GDO
    PMA / PMN Number
    K926502
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE: LADG - LAP ASSISTED DISTAL GASTRECTOMY. ACCORDING TO THE REPORTER: AFTER THE SIXTH FIRING, THE DEVICE COULD NOT BE REMOVED FROM TISSUE. THE DEVICE WAS REMOVED EVENTUALLY, BUT THE VESSEL WAS SLIGHTLY TORN. THE STAFF USED ANOTHER DEVICE TO CONTINUE THE CASE. THE VESSEL STOPPED BLEEDING AND THE BLEEDING THAT OCCURRED WAS UNDER 200CC. NOTHING FELL INTO THE PT CAVITY. TISSUE WAS DAMAGED. OPERATIVE TIME WAS NOT EXTENDED MORE THAN 30 MINUTES AND NO PT INFO AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAPR-CLIP 12MM LPW DISPOSABLE CLIP APPLIER GDO UNITED STATES SURGICAL N0B0521

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability