BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP** MCA

    MDR report key: 1881474 · Received October 25, 2010

    Report

    Report Number
    3005075853-2010-06040
    Event Type
    Malfunction
    Date Received
    October 25, 2010
    Date of Event
    September 27, 2010
    Report Date
    September 30, 2010
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDO
    PMA / PMN Number
    K820837
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME. (B)(4)

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS RESULTS FOUND THAT THE DEVICE 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. THE DEVICE WAS FOUND TO BE FULLY FUNCTIONAL AND CONFORMING TO OUR MANUFACTURING SPECIFICATIONS. NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE REPORTED INCIDENT. 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 LARYNGECTOMY PROCEDURE, THE DEVICE WAS FIRED ON A BRANCH OF THE JUGULAR VEIN WHEN THE SURGEON WENT TO APPLY THE CLIP THE VESSEL WAS CUT BY THE CLIP AND A COUPLE OF TIMES THE CLIPS SCISSORED AND DID NOT FORM PROPERLY. A MANUAL CLIP APPLIER WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE CONSEQUENCES REPORTED. NO DETAILS ARE AVAILABLE.

    Description of Event or Problem · 1

    INFORMATION RECEIVED INDICATES THE SIDERAIL WILL NOT LATCH DUE TO A BROKEN WELD ON THE SIDERAIL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGACLIP** MCA CLIP, IMPLANTABLE GDO ETHICON ENDO-SURGERY, LLC. G4TJ5M

    Patients

    Seq Age Sex Outcome Treatment
    1