BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX-5MM

    MDR report key: 1873235 · Received October 18, 2010

    Report

    Report Number
    3005075853-2010-05918
    Event Type
    Malfunction
    Date Received
    October 18, 2010
    Date of Event
    August 12, 2010
    Report Date
    August 13, 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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BROKEN JAW. THE ANALYSIS RESULTS FOUND THAT DEVICE (A) WAS RETURNED WITH THE LEFT JAW RAMP BROKEN. UPON FIRING OF THE DEVICE, THE REMAINING CLIPS WERE EJECTED DUE TO THE RETURNED CONDITION OF THE JAWS AND THEN, THE DEVICE LOCKED OUT AS INTENDED BUT THE ORANGE INDICATOR WAS VISIBLE AT 14TH FIRING SEQUENCE THUS, IT WAS NOT COMPLETELY VISIBLE. THIS FINDING IS NOT RELATED WITH THE INCIDENT REPORTED. THE ANALYSIS RESULTS FOUND THAT DEVICE (B) WAS RETURNED WITH THE TIP OF THE ADVANCER BROKEN THUS, PREVENTING THE PROPER ADVANCING OF THE CLIPS INTO THE JAWS. 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. THE DEVICE WAS CYCLED AND EJECTED THE REMAINING CLIPS DUE TO THE ADVANCER CONDITION. IN ADDITION, THE DEVICE LOCKED OUT AS INTENDED BUT THE ORANGE INDICATOR WAS NOT VISIBLE; THIS FINDING IS NOT RELATED WITH THE EVENT REPORTED. MALFORMED CLIP, BROKEN ADVANCER. 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 VEIN LIGATION PROCEDURE, THE DEVICE MISFIRED. NO OTHER DETAILS WERE PROVIDED. THERE WAS NO PATIENT IMPACT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGAMAX-5MM CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA F4PC0T

    Patients

    Seq Age Sex Outcome Treatment
    1