BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX- CLIP APPLIER

    MDR report key: 2112456 · Received June 3, 2011

    Report

    Report Number
    3005075853-2011-02276
    Event Type
    Malfunction
    Date Received
    June 3, 2011
    Date of Event
    April 8, 2011
    Report Date
    April 11, 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
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS RESULTS FOUND THAT THE DEVICE WAS RECEIVED IN GOOD VISUAL CONDITION. UPON CYCLING THE DEVICE, IT WAS NOTED TO BE EMPTY AND THE LOCKOUT HAD BEEN FIRED THROUGH. PLEASE NOTE THE DEVICE CONTAINS A LOCKOUT FEATURE THAT IS DESIGNED TO INCREASE THE REQUIRED FORCE IT TAKES TO CLOSE THE TRIGGER ONCE THE LAST CLIP HAS BEEN FIRED; THIS REDUCES THE POSSIBILITY OF EMPTY JAWS BEING CLOSED ON A STRUCTURE. IN ADDITION, IF THE TRIGGER IS FORCED CLOSED ONCE THE LOCKOUT HAS BEEN ENGAGED, THE JAWS MAY REMAIN IN THE CLOSED POSITION. IN ORDER TO EVALUATE THE CONDITION OF THE INTERNAL COMPONENTS, THE DEVICE WAS DISASSEMBLED. UPON DISASSEMBLING, THE INDICATOR WHEEL WAS FOUND TO BE BROKEN CAUSING THAT THE ORANGE INDICATOR WAS NOT VISIBLE AFTER THE 13TH FIRING SEQUENCE; HOWEVER, IT COULD NOT BE DETERMINED WHAT MAY HAVE CAUSED THIS CONDITION. IN ADDITION, THE RATCHET PAWL WAS NOTED WORN OUT. THIS FINDING IS UNRELATED WITH THE EVENT REPORTED. 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 GASTRECTOMY PROCEDURE, ALTHOUGH THE DEVICE FIRED UNTIL THE 15TH FIRING, THE INDICATOR DISPLAYED WHITE. THE DOCTOR CHECKED THE TRIGGER, IT WAS HARD AND NO CLIPS REMAINED IN THE DEVICE, AND THEN STOPPED USING THE DEVICE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1