BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX-5MM

    MDR report key: 1850415 · Received September 20, 2010

    Report

    Report Number
    3005075853-2010-05373
    Event Type
    Malfunction
    Date Received
    September 20, 2010
    Date of Event
    August 24, 2010
    Report Date
    August 27, 2010
    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
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). LOCKOUT BROKEN. DEVICE B: (B)(4), MFG DATE: 7/19/2010, EXP DATE: 6/19/2015. EVALUATION SUMMARY: THE ANALYSIS RESULTS FOUND THAT DEVICE (A) 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. DUE TO THE CONDITION OF THE DEVICE, NO FUNCTIONAL TESTING COULD BE PERFORMED TO EVALUATE THE REPORTED INCIDENT. THE ANALYSIS RESULTS FOUND THAT DEVICE (B) 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. IN ADDITION, THE DEVICE LOCKED OUT AS INTENDED BUT THE ORANGE INDICATOR OVER TRAVELED. THIS FINDING IS NOT RELATED WITH THE INCIDENT REPORTED. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS. THE FOLLOWING INFORMATION WAS PROVIDED DURING A CONFERENCE CALL EES ASSOCIATES AND THE SALES REP AND DIVISION MANAGER: RESIDENTS ARE HIGH USERS AT THIS FACILITY AND THE REP HAS BEEN IN-SERVICING AS NECESSARY. THE USERS MAY NOT BE INSPECTING THE JAWS PRIOR TO FIRING IN ORDER TO ENSURE THE CLIP HAS PROPERLY LOADED - THE REP WILL IN-SERVICE TO STRESS THE IMPORTANCE OF THIS STEP.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, THE DEVICE FIRED A SCISSORED CLIP ON THE FIRST FIRING. THE SECOND CLIP DID NOT FULLY FORM SO THE SURGEON PULLED IT FROM TISSUE. THE THIRD CLIP FELL OUT FROM THE JAWS. THE SECOND DEVICE WAS FIRED FOR SIX FIRINGS AND CLIPS WERE NOT FORMING, THERE WAS NOT A UNIFORM CLOSURE OF THE CLIP, THE LEGS WERE OFFSET FROM ONE ANOTHER. THE RESIDENT WAS THE ONE WHO FIRED THE DEVICE. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGAMAX-5MM FZP CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC NA G4TD0R

    Patients

    Seq Age Sex Outcome Treatment
    1