BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP*MCA MED APPLIER

    MDR report key: 1811524 · Received August 23, 2010

    Report

    Report Number
    3005075853-2010-04773
    Event Type
    Malfunction
    Date Received
    August 23, 2010
    Date of Event
    June 29, 2010
    Report Date
    July 27, 2010
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDO
    PMA / PMN Number
    K820837
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ASKED FOR BUT UNKNOWN OR NOT PROVIDED DURING INITIAL CONTACT. INFORMATION NOT AVAILABLE, DEVICE NOT RETURNED FOR ANALYSIS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A VASCULAR PROCEDURE, THERE WAS A CUTTING CLIP. THE CLIPS WOULDN'T HOLD ON A SMALL COLLATERAL ARTERY, AS THEY WERE NOT COMPLETELY CLOSED. MOREOVER, ONE OF THE CLIPS CUT THE VESSEL. THE ISSUE CAUSED A BLEEDING IN UNKNOWN QUANTITY BUT NOT REQUIRING A TRANSFUSION, ACCORDING TO OUR CONTACT. THE BLEEDING WAS CONTROLLED WITH COMPRESSES AND FASTIDIOUS MANUAL SUTURES DUE TO THE PROXIMITY OF LINGUAL AND FACIAL NERVES. THE PROCEDURE WAS EXTENDED BY THIRTY MINUTES. DEVICE WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGACLIP*MCA MED APPLIER CLIP, IMPLANTABLE GDO ETHICON ENDO-SURGERY, LLC. UNK G4RM7R

    Patients

    Seq Age Sex Outcome Treatment
    1