BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX 5MM

    MDR report key: 4121466 · Received September 26, 2014

    Report

    Report Number
    3005075853-2014-06691
    Event Type
    Malfunction
    Date Received
    September 26, 2014
    Date of Event
    August 19, 2014
    Report Date
    August 22, 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
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) = ADVANCER. THE ANALYSIS RESULTS FOUND THAT ONE EL5ML DEVICE WAS RECEIVED IN GOOD VISUAL CONDITION. IN AN ATTEMPT TO REPLICATE THE EVENT REPORTED, THE DEVICE WAS TESTED FOR FUNCTIONALITY. UPON TESTING, THE DEVICE WAS CYCLED AND IT FED AND FORMED TWO CONFORMING CLIPS AND TWO CLIPS WITH GAP. THE DEVICE WAS NOTED TO HAVE THE TIP OF THE ADVANCER BENT. A POSSIBLE CAUSE FOR THE CONDITION OF BENT ADVANCER IS ACTUATING THE DEVICE WHEN THE JAWS ARE NOT CLEAR OF THE TROCAR. ACTUATING THE DEVICE WITH THE JAWS CLOSED MAY BEND THE ADVANCER. 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. 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. 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 LAPAROSCOPIC SIGMOIDECTOMY, THE CLIP WAS NOT FULLY ADVANCED INTO THE JAWS AT THE 1ST FIRING. THERE WAS AN UNEXPECTED RESISTANCE IN GRASPING THE TRIGGER. ALTHOUGH OOZING OCCURRED, ASTRICTION WAS PERFORMED WITH GAUZE AND IT WAS STOPPED. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601362 LIGAMAX 5MM CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA L4EK2V

    Patients

    Seq Age Sex Outcome Treatment
    1