BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP*MCA

    MDR report key: 1840920 · Received September 22, 2010

    Report

    Report Number
    3005075853-2010-05458
    Event Type
    Malfunction
    Date Received
    September 22, 2010
    Date of Event
    August 26, 2010
    Report Date
    August 31, 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 Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MISASSEMBLED HOOP SPRING. THE ANALYSIS RESULTS FOUND THAT THE DEVICE WAS RECEIVED IN GOOD CONDITION. IN AN ATTEMPT TO REPLICATE THE REPORTED INCIDENT, THE DEVICE WAS TESTED FOR FUNCTIONALITY. UPON TESTING, THE TRIGGER COULD NOT BE COMPLETELY ACTIVATED DUE TO IT WAS JAMMED. IN ORDER TO EVALUATE THE CONDITION OF THE DEVICE'S INTERNAL COMPONENTS, THE DEVICE WAS DISASSEMBLED. UPON DISASSEMBLY, THE HOOP SPRING WAS FOUND MISASSEMBLED AND LOSES INSIDE THE DEVICE, JAMMING THE FIRING MECHANISM. NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE FOUND CONDITION. NO INCIDENT RELATED TO THE REPORTED EVENT WAS OBSERVED DURING THE BATCH RECORD REVIEW.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A FEMORAL POPLITEAL PROCEDURE, THE DEVICE FIRED 2 OR 3 CLIPS THEN THE CLIPS STOPPED ADVANCING INTO THE JAWS, THE CLIPS WERE JAMMED. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE CONSEQUENCES REPORTED. ONE DEVICE WILL BE RETURNED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1