BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX-5MM

    MDR report key: 2180376 · Received July 27, 2011

    Report

    Report Number
    3005075853-2011-03025
    Event Type
    Malfunction
    Date Received
    July 27, 2011
    Date of Event
    June 27, 2011
    Report Date
    July 8, 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
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS RESULTS FOUND THAT THE DEVICE 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. 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: WHICH FIRING OF THE DEVICE DID THIS EVENT OCCUR ON? IT OCCURRED ON THE FIRST TIME THE SURGEON TRIED TO FIRE THE DEVICE. WHAT VESSEL OR STRUCTURE WAS THE DEVICE FIRED ON AT THE TIME OF THE EVENT? IT WAS MEANT TO SEAL THE DUCTUS CHOLEDOCHUS DURING A LAPAROSCOPIC CHOLECYSTECTOMY. WAS THE CLIP FULLY ADVANCED INTO THE JAWS PRIOR TO FIRING? YES, THE CLIP WAS FULLY ADVANCED BEFORE FIRING. 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. WERE ANY UNEXPECTED NOISES HEARD? IF SO, WHEN? NO. DID ANYTHING UNEXPECTED HAPPEN PRIOR TO THIS INCIDENT? NO. WAS THE DEVICE FIRED AFTER THIS INCIDENT IN OR OUT OF THE PATIENT? NO.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, THE SURGEON TRIED TO FIRE THE CLIP BUT WAS NOT ABLE TO CLOSE THE CLIP COMPLETELY, THE CLIP WAS ONLY CLOSING ON THE TIP. 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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1