BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX-5MM ENDO CLIP APPLIER

    MDR report key: 1080410 · Received July 24, 2008

    Report

    Report Number
    3005075853-2005-00392
    Event Type
    Malfunction
    Date Received
    July 24, 2008
    Date of Event
    June 2, 2008
    Report Date
    June 18, 2008
    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
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT: 7/11/2008. BROKEN ADVANCER. THE ANALYSIS RESULTS FOUND THAT ONE EL5ML DEVICE WAS RETURNED WITH THE ADVANCER TIP BROKEN OFF. THE INSTRUMENT WAS CYCLED AND IT SHORT FED AN MALFORMED THE REMAINING CLIPS DUE TO THE ADVANCER CONDITION. AS PER THE INSTRUCTIONS FOR USE: "PRIOR TO LOADING A CLIP IN THE JAWS, ENSURE THAT THE DEMARCATION BETWEEN THE JAWS AND THE INSTRUMENT SHAFT IS PAST THE END OF THE TROCAR CANNULA." FURTHER IN THE WARNING SECTION, THE IFU CONTAINS THE FOLLOWING WARNING, "DO NOT EXCESSIVELY APPLY A SIDE LOAD TO THE JAWS THAT WOULD CAUSE THEM TO PARTIALLY COLLAPSE AND POTENTIALLY RESULT IN A CLIP MALFORMATION. THE DEVICE JAWS SHOULD BE FULLY OPEN AND PARALLEL UPON INITIATING THE FIRING OF THE INSTRUMENT." WE HAVE DOCUMENTED THE CIRCUMSTANCES AS THEY WERE REPORTED TO US. IN ADDITION, COMPLAINT INFO IS TRENDED ON A REGULAR BASIS TO DETERMINE IF FURTHER INVESTIGATION IS WARRANTED. A BATCH RECORD REVIEW WAS PERFORMED AND NO ANOMALIES WERE FOUND DURING THE MANUFACTURING PROCESS. .

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAP CHOLE PROCEDURE, THE NOTE STATES "THE DEVICE IS NOT FIRING PROPERLY". NO ADDITIONAL INFO IS AVAILABLE. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGAMAX-5MM ENDO CLIP APPLIER NONE FZP ETHICON ENDO-SURGERY, LLC. NA E4KC5G

    Patients

    Seq Age Sex Outcome Treatment
    1