BEUDAMED
    FDA Adverse Event Other Summary report: N

    ANASTOCLIP CLIP APPLIER

    MDR report key: 1312133 · Received February 9, 2009

    Report

    Report Number
    1220948-2009-00003
    Event Type
    Other
    Date Received
    February 9, 2009
    Date of Event
    January 6, 2009
    Report Date
    February 3, 2009
    Manufacturer
    LEMAITRE VASCULAR, INC.
    Product Code
    GDO
    PMA / PMN Number
    K933887
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS NOT RETURNED FOR EVAL. THE LOT NUMBER OF THE COMPLAINT DEVICE WAS NOT RECORDED AND SENT TO US. WE RAN A REPORT OF THE DEVICES SOLD IN THE LAST 6 MONTHS AND RECORDED THE HOSPITAL'S LOT NUMBER PURCHASE HISTORY IN THE COMPLAINT FILE. THE LOT HISTORY RECORDS WERE REVIEWED FOR ALL LOT NUMBERS AND ALL MFG AND QC INSPECTIONS WERE COMPLETED IN ACCORDANCE TO THE INSTRUCTIONS. WE TOOK THREE DEVICES FROM THE SAME LOTS THAT THE HOSPITAL PURCHASED AND PUT THEM THROUGH THE SAME SERIES OF TESTS FOR PRODUCT FUNCTIONALITY. ALL THREE APPLIERS PROVIDED ACCEPTABLE RESULTS. THE CURRENT ANALYSIS HAS NOT PROVIDED A ROOT CAUSE.

    Description of Event or Problem · 1

    THE SURGEON STATED THAT THE CLIPS FAIL TO ARTICULATE (CLOSE) AND WAS NOT GENERALLY NOTED UNTIL THE VESSEL CLAMPS WERE RELEASED, AT WHICH TIME THE PT WAS BLEEDING. THE VEIN WOULD BE SUTURED CLOSED. LOOSE CLIPS WERE FOUND ON OR AROUND THE VESSEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANASTOCLIP CLIP APPLIER CLIP APPLIER GDO LEMAITRE VASCULAR, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1