BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP CLIP APPLIER

    MDR report key: 3811437 · Received May 15, 2014

    Report

    Report Number
    3005075853-2014-03258
    Event Type
    Malfunction
    Date Received
    May 15, 2014
    Report Date
    April 17, 2014
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDO
    PMA / PMN Number
    EXEMPT
    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). DAMAGED JAWS. THE ANALYSIS RESULTS CONFIRMED THAT THE LX107 DEVICE WAS RETURNED NON FUNCTIONAL AS THE JAWS WERE MISALIGNED; THEREFORE, THE CLIPS COULD NOT BE LOADED INTO THE JAWS. NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE FOUND CONDITION OF THE JAWS. IT SHOULD BE NOTED THAT AS PART OF OUR QUALITY PROCESS, EACH DEVICE IS VISUALLY INSPECTED AND FUNCTIONALLY TESTED DURING MANUFACTURING TO ENSURE THE DEVICE MEETS THE REQUIRED SPECIFICATIONS PRIOR TO SHIPMENT. EVENT COULD NOT BE CONFIRMED AS THE DEVICE OPENED AND CLOSED WITHOUT ANY DIFFICULTIES NOTED. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CORONARY ARTERY BYPASS GRAFT PROCEDURE, THE CLIPS SCISSORED AND DEVICE WAS NOT HOLDING CLIPS. THE CASE WAS COMPLETED WITH ANOTHER DEVICE OF THE SAME PRODUCT CODE. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290021 LIGACLIP CLIP APPLIER APPLIER, SURGICAL, CLIP GDO ETHICON ENDO-SURGERY, LLC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1