BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX CLIP APPLIER

    MDR report key: 3870117 · Received June 12, 2014

    Report

    Report Number
    3005075853-2014-03948
    Event Type
    Malfunction
    Date Received
    June 12, 2014
    Date of Event
    April 9, 2014
    Report Date
    April 14, 2014
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    FZP
    PMA / PMN Number
    K050344
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IN AN ATTEMPT TO REPLICATE THE REPORTED INCIDENT, THE DEVICE WAS TESTED FOR FUNCTIONALITY. UPON FIRING OF THE DEVICE, THE TIP OF THE ADVANCER WAS NOTED BROKEN CAUSING THE CLIP TO NOT FULLY ADVANCE INTO THE JAW. THE DEVICE WAS CYCLED AND IN THE NEXT TWO ACTUATIONS, TWO PEAR SHAPED CLIPS WERE FORMED DUE TO THE BROKEN ADVANCER. THE DEVICE WAS DISASSEMBLED IN ORDER TO INSPECT THE INTERNAL COMPONENTS AND NO ADDITIONAL ANOMALIES WERE FOUND. ONE POSSIBLE CAUSE FOR THE CONDITION FOUND IS ACTUATING THE DEVICE WHEN THE JAWS ARE NOT CLEAR OF THE TROCAR. ACTUATING THE DEVICE WITH THE JAWS CLOSED MAY BEND THE ADVANCER. SUBSEQUENT ACTUATIONS OR MANUAL OPENING OF THE DEVICE MAY BEND THE ADVANCER TIP BACK TOWARD ITS ORIGINAL POSITION AND BREAK THE ADVANCER TIP. PLEASE NOTE THAT PRIOR TO LOADING A CLIP IN THE JAWS, ENSURE THAT THE DEMARCATION BETWEEN THE JAWS AND THE DEVICE SHAFT IS PAST THE END OF THE TROCAR CANNULA. ADDITIONALLY, EXCESSIVELY APPLYING A SIDE LOAD TO THE JAWS, CAUSING THEM TO PARTIALLY COLLAPSE COULD RESULT IN A CLIP MALFORMATION. THE DEVICE JAWS SHOULD BE FULLY OPEN AND PARALLEL UPON INITIATING THE FIRING OF THE DEVICE. POSSIBLE CAUSES FOR THE DAMAGE FOUND ON THE SHAFT MAY BE INADVERTENT PRESSURE PLACED ON THE DEVICE SHAFT THROUGH BENDING, PRESSING AGAINST THE TROCAR, OTHER DEVICES ON THE BACK TABLE, USING THE DEVICE AS A RETRACTOR OR MOVING HEAVY TISSUE WITH THE DEVICE SHAFT. 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 CHOLECYSTECTOMY PROCEDURE, THE CLIP GETS STUCK PREVENTING CLIPS OUT, NO CLIP OUT. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT. ONE DEVICE WILL BE RETURNED. CLIPS WOULD NOT ADVANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    348359 LIGAMAX CLIP APPLIER CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA L4E34E

    Patients

    Seq Age Sex Outcome Treatment
    1