BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX-5MM

    MDR report key: 1894878 · Received November 10, 2010

    Report

    Report Number
    3005075853-2010-06406
    Event Type
    Malfunction
    Date Received
    November 10, 2010
    Date of Event
    October 14, 2010
    Report Date
    October 14, 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
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS RESULTS FOUND THAT DEVICE (A) WAS RECEIVED IN GOOD VISUAL CONDITION. IN AN ATTEMPT TO REPLICATE THE EVENT REPORTED, THE DEVICE WAS TESTED FOR FUNCTIONALITY. UPON TESTING TWO UNFORMED CLIPS WERE FED. THE REMAINING CLIPS WERE CONFORMING ACCORDING TO MANUFACTURING SPECIFICATIONS. THE UNFORMED CLIP WAS DETERMINED TO BE CAUSED BY AN INTERMITTENT FAILURE OF THE ANTI-BACKUP FEATURE. THE DEVICE WAS DISASSEMBLED TO VERIFY THE CONDITION OF THE INTERNAL COMPONENTS AND THE RATCHET PAWL WAS FOUND TO BE DAMAGED CAUSING THE ANTI-BACKUP FAILURE. POSSIBLE CAUSES FOR THIS CONDITION MAY BE ATTEMPTING TO SQUEEZE THE DEVICE TRIGGER WHEN IT HAS NOT FULLY RETURNED OR STOPPING THE FIRING SEQUENCE AND PULLING THE TRIGGER OPEN. IN ADDITION, THE DEVICE LOCKED OUT AS INTENDED BUT THE ORANGE INDICATOR WAS VISIBLE AT 11TH FIRING SEQUENCE THUS, IT OVER TRAVELED. THIS FINDING IS NOT RELATED WITH THE EVENT REPORTED. THE ANALYSIS RESULTS FOUND THAT ONE EL5ML DEVICE (B) WAS RECEIVED 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 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 EVENT REPORTED. NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE REPORTED INCIDENT. (B)(4). THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE THE DEVICE FIRED MALFORMED CLIPS, TEAR SHAPED CLIPS, AND SCISSORED CLIPS. THE CLIPS WERE STICKING IN THE JAWS. A SECOND DEVICE WAS PULLED AND THE SAME THING OCCURRED. A THIRD DEVICE WAS PULLED AND THE CASE WAS COMPLETED WITH NO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGAMAX-5MM CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA G4TZ3Y

    Patients

    Seq Age Sex Outcome Treatment
    1