BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX-5MM

    MDR report key: 2200026 · Received August 10, 2011

    Report

    Report Number
    3005075853-2011-03248
    Event Type
    Malfunction
    Date Received
    August 10, 2011
    Date of Event
    July 14, 2011
    Report Date
    July 20, 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) FEEDBAR. THE ANALYSIS RESULTS OF THE DEVICE FOUND THAT IT WAS RECEIVED IN GOOD VISUAL CONDITION. IN AN ATTEMPT TO REPLICATE THE REPORTED INCIDENT, THE DEVICE WAS TESTED FOR FUNCTIONALITY. UPON FIRING, THE DEVICE FED AND PROPERLY FORMED THREE CLIPS AND THEN, A DOUBLE FEED INCIDENT WAS NOTED (11TH FIRING SEQUENCE). DURING THE NEXT FIRING SEQUENCE, THE TIP OF THE ADVANCER SLID TOWARD TISSUE STOP CAUSING THAT THE JAWS REMAINED IN THE CLOSED POSITION. THE TRIGGER WAS MANUALLY ASSISTED IN ORDER TO OPEN THE JAWS; ONE PEAR SHAPED CLIP WAS RELEASED. THE REMAINED CLIPS WERE CONFORMING ACCORDING TO OUR MANUFACTURING SPECIFICATIONS. IN ADDITION, THE DEVICE LOCKED OUT AS INTENDED BUT THE ORANGE INDICATOR WAS NOT VISIBLE PLEASE NOTE THAT THIS CONDITION IS UNRELATED WITH THE INCIDENT REPORTED. IN ORDER TO EVALUATE THE CONDITION OF THE DEVICE'S INTERNAL COMPONENTS, THE DEVICE WAS DISASSEMBLED. UPON DISASSEMBLING, FLASH ON THE POCKETS 6TH AND 12TH OF THE OVERMOLD ADVANCER FEED BAR WAS NOTED LEADING THE FOUND DOUBLE FEED ISSUE DURING TESTING. EXCESSIVE FLASH OR SURFACE IRREGULARITIES IN THESE POCKETS WILL INDICATE THAT THE CONTACT DRAG FORCES OF THESE POCKETS WITH THE FEEDER SHOE FEED TAB WERE HIGH AND THEREFORE ABLE TO OVERCOME THE RETENTION STRENGTH OF THE CLIP TRACK TAB WHICH ALLOWED THE FEEDER SHOE TO PREMATURELY ADVANCE THE CLIP STACK DURING THE INITIAL FEEDING CYCLE. THIS CONDITION MAY CAUSE THE CLIPS JAMMED IN THE JAWS. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: WAS THE CLIP FULLY ADVANCED INTO THE JAWS PRIOR TO FIRING? NO. WAS THERE ANY TORQUING OR TWISTING OF THE DEVICE PRESENT AT THE TIME OF FIRING? NO. WAS ANY UNEXPECTED RESISTANCE FELT WHILE FIRING THE TRIGGER? NO INFORMATION. WERE ANY UNEXPECTED NOISES HEARD? IF SO, WHEN? NO INFORMATION. DID ANYTHING UNEXPECTED HAPPEN PRIOR TO THIS INCIDENT? NO. DID THE SURGEON TRY TO PULL THE TRIGGER FROM THE HANDLE? NO INFORMATION. IS THE SURGEON AWARE THAT THE FIRING TRIGGER MAY NEED ASSISTANCE IN RETURNING ALL THE WAY FORWARD? NO INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPY-ASSISTED DISTAL GASTRECTOMY PROCEDURE, THE DEVICE WAS FIRED OUTSIDE THE PATIENT TO CHECK ITS FUNCTION. THE 1ST CLIP WAS JAMMED AND THE JAW WOULD NOT OPEN AFTER THE 2ND CLIP WAS FIRED. THE DEVICE WAS NOT USED FOR THE PATIENT. 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 LIGAMAX-5MM CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA H4384F

    Patients

    Seq Age Sex Outcome Treatment
    1