BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP MCA SMALL APPLIER

    MDR report key: 3984342 · Received August 6, 2014

    Report

    Report Number
    3005075853-2014-05492
    Event Type
    Malfunction
    Date Received
    August 6, 2014
    Date of Event
    July 3, 2014
    Report Date
    July 8, 2014
    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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) = RETURNED EMPTY. THE ANALYSIS RESULTS FOUND THAT THE MCS20 DEVICE WAS RETURNED CYCLED WITH THE JAWS CLOSED. UPON VISUAL INSPECTION, THE INSTRUMENT WAS NOTED TO BE EMPTY. THE HANDLES WERE RELEASED IN ORDER TO COMPLETE THE CYCLE AND UPON EVALUATION, THE LOCKOUT MECHANISM WAS FOUND TO BE NON FUNCTIONAL. DUE TO THE RETURNED CONDITION OF THE DEVICE, NO FURTHER TESTING COULD BE PERFORMED. IN ORDER TO EVALUATE THE CONDITION OF THE INTERNAL COMPONENTS, THE DEVICE WAS DISASSEMBLED AND THE LOCKOUT SPRING WAS NOTED OUT OF POSITION. NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THAT THE LOCKOUT SPRING WAS OUT OF POSITION. 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 AN UNKNOWN PROCEDURE, ONE CLIP APPLIER WOULD NOT FIRE AND THE OTHER CLIP APPLIER LOCKED OUT. CASE COMPLETED WITH ONE NEW DEVICE EACH OF THE SAME PRODUCT CODE. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    461764 LIGACLIP MCA SMALL APPLIER CLIP, IMPLANTABLE GDO ETHICON ENDO-SURGERY, LLC. NA K4CN5V

    Patients

    Seq Age Sex Outcome Treatment
    1