BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX-5MM ENDO CLIP APPLIER

    MDR report key: 1831978 · Received September 13, 2010

    Report

    Report Number
    3005075853-2010-05214
    Event Type
    Malfunction
    Date Received
    September 13, 2010
    Date of Event
    August 17, 2010
    Report Date
    August 18, 2010
    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
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4). INSTRUMENT A: INDICATOR. (B)(4) (SHAFT). THE ANALYSIS RESULTS FOUND THAT THE EL5ML DEVICE (A) WAS RETURNED IN GOOD VISUAL CONDITION. IN AN ATTEMPT TO REPLICATE THE REPORTED INCIDENT, THE DEVICE WAS TESTED FOR FUNCTIONALITY. UPON TESTING, THE DEVICE WAS CYCLED, FED, AND FORMED THE REMAINING CLIPS AS INTENDED. THE CLIPS WERE EVALUATED WITH THE FUNNEL GAGE AND THEY WERE CONFORMING ACCORDING TO OUR MANUFACTURING SPECIFICATIONS. IN ADDITION, THE DEVICE LOCKED OUT AS INTENDED, BUT THE ORANGE INDICATOR WAS VISIBLE AT 11TH FIRING SEQUENCE THUS, IT OVER TRAVELED. HOWEVER, THIS FINDING IS NOT RELATED WITH THE INCIDENT REPORTED. THE ANALYSIS RESULTS FOUND THAT THE EL5ML DEVICE (B) WAS RETURNED IN GOOD VISUAL CONDITION. IN AN ATTEMPT TO REPLICATE THE REPORTED INCIDENT, THE DEVICE WAS TESTED FOR FUNCTIONALITY. UPON TESTING, THE DEVICE WAS CYCLED, FED, AND FORMED THE REMAINING CLIPS AS INTENDED. THE DEVICE WAS FOUND TO BE FULLY FUNCTIONAL AND CONFORMING TO OUR MANUFACTURING SPECIFICATIONS. NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE REPORTED INCIDENT. THE ANALYSIS RESULTS FOUND THAT THE EL5ML DEVICE (C) WAS RETURNED INSIDE ITS ORIGINAL PACKAGE. FURTHER EVALUATION, FOUND THAT THE SHAFT WAS NOTED BROKEN AT DISTAL. IN AN ATTEMPT TO REPLICATE THE REPORTED INCIDENT, THE DEVICE WAS TESTED FOR FUNCTIONALITY TO EVALUATE ANY MALFORMED CLIPS. UPON FIRING OF THE DEVICE, ONE CLIP WAS EJECTED AND THEN, THE FIRING MECHANISM GOT JAMMED DUE TO THE FOUND CONDITION OF THE SHAFT. NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE FOUND CONDITION. DUE TO THE CONDITION OF THE DEVICE, NO FUNCTIONAL TESTING COULD BE PERFORMED TO EVALUATE THE REPORTED INCIDENT. THE ANALYSIS RESULTS FOUND THAT THE EL5ML DEVICE (D) WAS RETURNED INSIDE ITS ORIGINAL PACKAGE. IN AN ATTEMPT TO REPLICATE THE REPORTED INCIDENT, THE DEVICE WAS TESTED FOR FUNCTIONALITY. UPON TESTING, THE DEVICE WAS CYCLED, FED, AND FORMED THE REMAINING CLIPS AS INTENDED. THE DEVICE WAS FOUND TO BE FULLY FUNCTIONAL AND CONFORMING TO OUR MANUFACTURING SPECIFICATIONS. NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE REPORTED INCIDENT. THE ANALYSIS RESULTS FOUND THAT THE EL5ML DEVICE (E) WAS RETURNED INSIDE ITS ORIGINAL PACKAGE. IN AN ATTEMPT TO REPLICATE THE REPORTED INCIDENT, THE DEVICE WAS TESTED FOR FUNCTIONALITY. UPON TESTING, THE DEVICE WAS CYCLED, FED, AND FORMED THE REMAINING CLIPS AS INTENDED. THE DEVICE WAS FOUND TO BE FULLY FUNCTIONAL AND CONFORMING TO OUR MANUFACTURING SPECIFICATIONS. NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE REPORTED INCIDENT. 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 CHOLE PROCEDURE, THE CLIPS WERE NOT CLOSING PROPERLY. ONE SIDE WAS STRAIGHT AND THE OTHER SIDE WAS FORMED. ANOTHER DEVICE WAS PULLED AND THE SAME THING OCCURRED. A THIRD DEVICE FROM THE DIFFERENT LOT NUMBER WAS USED TO COMPLETE THE CASE WITH NO PATIENT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGAMAX-5MM ENDO CLIP APPLIER CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA G4TK0A

    Patients

    Seq Age Sex Outcome Treatment
    1