BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX-5MM

    MDR report key: 2140584 · Received June 27, 2011

    Report

    Report Number
    3005075853-2011-02597
    Event Type
    Malfunction
    Date Received
    June 27, 2011
    Date of Event
    May 23, 2011
    Report Date
    May 31, 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
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION WAS REQUESTED. 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 BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS. 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. THE REMAINING CLIPS WERE CONFORMING ACCORDING TO OUR MANUFACTURING SPECIFICATIONS. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS. (B)(4). JAWS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CHOLECYSTECTOMY PROCEDURE, THE CLIP FAILED TO RELEASE FROM THE JAWS AND THE JAWS WOULD NOT RELEASE OFF THE CYSTIC ARTERY. IT IS UNKNOWN HOW IT WAS REMOVED. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. NO PATIENT IMPACT REPORTED. NO OTHER DETAILS OF THE EVENT WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGAMAX-5MM CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA G4U98H

    Patients

    Seq Age Sex Outcome Treatment
    1