BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP MULTIPLE CLIP APPLIER

    MDR report key: 288131 · Received July 28, 2000

    Report

    Report Number
    1527736-2000-03403
    Event Type
    Malfunction
    Date Received
    July 28, 2000
    Date of Event
    June 20, 2000
    Report Date
    July 12, 2000
    Manufacturer
    LACEY MANUFACTURING CO
    Product Code
    GDO
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED ON EXTERNAL MEDWATCH NUMBER 180010-2000-011 THAT THE (1) MCL20 WAS USED DURING AN ABDOMINAL AORTIC ANEURYSM REPAIR PROCEDURE. IT WAS REPORTED THAT THE STAPLER BROKE WHEN USED TO APPLY CLIPS. THIS CAUSED THE PROCEDURE TO BE PROLONGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGACLIP MULTIPLE CLIP APPLIER GDO LACEY MANUFACTURING CO NA

    Patients

    Seq Age Sex Outcome Treatment
    1