BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX-5MM

    MDR report key: 2042964 · Received April 7, 2011

    Report

    Report Number
    3005075853-2011-01390
    Event Type
    Malfunction
    Date Received
    April 7, 2011
    Date of Event
    March 11, 2011
    Report Date
    March 15, 2011
    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
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS RESULTS FOUND THAT 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. NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE REPORTED INCIDENT. IN ADDITION, THE DEVICE LOCKED OUT AS INTENDED BUT THE ORANGE INDICATOR UNDER TRAVELED. THE ORANGE VISUAL INDICATOR IS A MECHANISM IN THE HANDLE OF THE DEVICE THAT SHOWS "ORANGE" WHEN THE DEVICE HAS EXHAUSTED ITS CLIPS. POTENTIAL CAUSES OF AN UNDER TRAVELED ORANGE VISUAL INDICATOR MAY BE: THE INDICATOR WHEEL IN THE HANDLE OF THE DEVICE MAY BECOME TEMPORARILY DISENGAGED DUE TO A DIMENSIONAL SHIFT OF MULTIPLE COMPONENTS INVOLVED ALLOWING TWO COMPONENTS TO SLIP PAST ONE ANOTHER; HIGHER THAN NORMAL FRICTION OF THE MECHANISM MAY CAUSE ONE OR MORE PARTS TO TEMPORARILY STICK. PLEASE NOTE THE UNDER-TRAVEL OF THE INDICATOR WHEEL IS NOT RELATED TO THE REPORTED EVENT. THE ANALYSIS RESULTS FOUND THAT DEVICE (B) WAS RECEIVED IN GOOD VISUAL CONDITION. IN AN ATTEMPT TO REPLICATE THE REPORTED INCIDENT, THE DEVICE WAS TESTED FOR FUNCTIONALITY. UPON FIRING OF THE DEVICE, THE TIP OF THE ADVANCER SLID TOWARD TISSUE STOP CAUSING THAT THE JAWS REMAINED IN THE CLOSED. THE TRIGGER WAS MANUALLY ASSISTED IN ORDER TO OPEN THE JAWS WITHOUT ANY DIFFICULTIES NOTED; A PEAR SHAPED CLIP WAS RELEASED. IN ADDITION, THE DEVICE LOCKED OUT AS INTENDED BUT THE ORANGE INDICATOR WAS NOT VISIBLE. PLEASE NOTE THAT THE INDICATOR FAILURE IS NOT RELATED WITH THE INCIDENT REPORTED. (B)(4). 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 CHOLECYSTECTOMY PROCEDURE THE DEVICE FIRED FINE AT THE FIRST FIRING. THE FOLLOWING CLIPS WERE MALFORMED, OPENED OR NOT FEEDING PROPERLY. ONE OF THE DEVICES DROPPED FROM THE DEVICE. ANOTHER DEVICE WAS PULLED AND THE CLIPS WERE NOT CLOSING CORRECTLY. AT THE BEGINNING OF THE PROCEDURE HARMONIC WAS USED FOR DISSECTION, SO THE SURGEON USED THE HARMONIC TO COMPLETE THE CASE. THERE WAS NO PATIENT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGAMAX-5MM CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA H4352X

    Patients

    Seq Age Sex Outcome Treatment
    1