BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MCA MED APPLIER

    MDR report key: 2193397 · Received August 5, 2011

    Report

    Report Number
    3005075853-2011-03198
    Event Type
    Malfunction
    Date Received
    August 5, 2011
    Report Date
    July 13, 2011
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDO
    PMA / PMN Number
    K820837
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS RESULTS FOR THE INSTRUMENT CONFIRMED THAT IT WAS RETURNED NON-FUNCTIONAL. A CLIP WAS INCORRECTLY LOADED INTO THE CLIP TRACK; THEREFORE, THE REMAINING CLIPS WOULD NOT BE FED INTO THE JAWS. IN ADDITION, THE TRIGGER COULD NOT BE COMPLETELY ACTIVATED DUE TO THE FIRING MECHANISM WAS JAMMED. IN ORDER TO EVALUATE THE CONDITION OF THE DEVICE'S INTERNAL COMPONENTS, THE DEVICE WAS DISASSEMBLED. UPON DISASSEMBLING, THE HOOP SPRING WAS FOUND OUT OF ITS INTENDED POSITION, JAMMING THE FIRING MECHANISM. NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE FOUND CONDITION OF THE HOOP SPRING. PLEASE NOTE THAT THE RETURNED CONDITION OF THE DEVICE IS NOT RELATED TO THE INCIDENT REPORTED. DUE TO THE CONDITION OF THE DEVICE, NO FUNCTIONAL TESTING COULD BE PERFORMED TO EVALUATE 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 WHIPPLE PROCEDURE, THE CLIPS DIDN'T CLOSE COMPLETELY AND FELL OUT OF THE JAWS. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MCA MED APPLIER CLIP, IMPLANTABLE GDO ETHICON ENDO-SURGERY, LLC. NA H43COL

    Patients

    Seq Age Sex Outcome Treatment
    1