BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX-5MM

    MDR report key: 2072664 · Received April 29, 2011

    Report

    Report Number
    3005075853-2011-01779
    Event Type
    Malfunction
    Date Received
    April 29, 2011
    Date of Event
    February 6, 2011
    Report Date
    February 25, 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
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DOUBLE FEED. THE ANALYSIS RESULTS FOUND THAT THE DEVICE WAS RECEIVED IN GOOD CONDITION. IN AN ATTEMPT TO REPLICATE THE EVENT REPORTED, THE DEVICE WAS TESTED FOR FUNCTIONALITY. UPON TESTING, A DOUBLE FEED INCIDENT WAS NOTED CAUSING CLIPS PARTIALLY FORMED. THE REMAINING CLIPS WERE CONFORMING ACCORDING TO OUR MANUFACTURING SPECIFICATIONS. IT IS POSSIBLE THAT THE FEEDING ISSUE OCCURRED AS A RESULT OF THE TRIGGER NOT ENGAGING THE ANTI-BACKUP RATCHET PRIOR TO RELEASING; HOWEVER, NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE FOUND CONDITION. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY THE DEVICE DOES NOT DEPLOY A CLIP FROM THE JAWS. THEY COMPLETED THE PROCEDURE WITH A NEW LIKE DEVICE. THERE WAS NO PATIENT CONSEQUENCE REPORTED.

    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