BEUDAMED
    FDA Adverse Event Other Summary report: N

    ETHICON ENDO-SURGERY, LLC

    MDR report key: 3423401 · Received September 4, 2013

    Report

    Report Number
    3423401
    Event Type
    Other
    Date Received
    September 4, 2013
    Date of Event
    August 27, 2013
    Report Date
    August 30, 2013
    Manufacturer
    ETHICON ENDO-SURGERY LLC
    Product Code
    FZP
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    SECOND CLIP OUT OF THE GUN FAILED TO SECURE AN ARTERY. THE SURGEON HAS REQUESTED WE DISCONTINUE USE. DURING SURGERY, THE EQUIPMENT FIRED THE FIRST CLIP WITHOUT PROBLEM. THE SECOND ONE DID NOT FIRE, CAUSING BLOOD LOSS AND ADDITIONAL PATIENT CONCERNS. I BELIEVE THIS PRODUCT WAS PREVIOUSLY RECALLED. WE HAVE REMOVED ALL OF THIS PARTICULAR PRODUCT FROM OUR INVENTORY AT THIS POINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    439733 ETHICON ENDO-SURGERY, LLC LIGA-CLIP APPLIER FZP ETHICON ENDO-SURGERY LLC ER320 K4D18M

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR