BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX-5MM ENDO CLIP APPLIER

    MDR report key: 1024208 · Received March 27, 2008

    Report

    Report Number
    1527736-2008-01927
    Event Type
    Malfunction
    Date Received
    March 27, 2008
    Report Date
    February 25, 2008
    Manufacturer
    ETHICON ENDO-SURGERY, INC.(CINCINNATI)
    Product Code
    FZP
    PMA / PMN Number
    K050344
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE ANALYSIS RESULTS FOUND THAT ONE EL5ML DEVICE WAS RETURNED WITH THE ADVANCER TIP BROKEN OFF. THE INSTRUMENT WAS CYCLED AND IT SHORT FED THE REMAINING CLIPS DUE TO THE MALFORMED CLIPS, THE TRIGGER HAD TO BE MANUALLY ASSISTED TO RE-OPEN THE JAWS. AS PER THE INSTRUCTIONS FOR USE: "PRIOR TO LOADING A CLIP IN THE JAWS, ENSURE THAT THE DEMARCATION BETWEEN THE JAWS AND THE INSTRUMENT SHAFT IS PAST THE END OF THE TROCAR CANNULA." FURTHER IN THE WARNING SECTION, THE IFU CONTAINS THE FOLLOWING WARNING, "DO NOT EXCESSIVELY APPLY A SIDE LOAD TO THE JAWS THAT WOULD CAUSE THEM TO PARTIALLY COLLAPSE AND POTENTIALLY RESULT IN A CLIP MALFORMATION. THE DEVICE JAWS SHOULD BE FULLY OPEN AND PARALLEL UPON INITIATING THE FIRING OF THE INSTRUMENT." IN ADDITION, THE ORANGE INDICATOR DID NOT SHOW UP AFTER THE DEVICE LOCKED UP. WE HAVE DOCUMENTED THE CIRCUMSTANCES AS THEY WERE REPORTED TO US. IN ADDITION, COMPLAINT INFO IS TRENDED ON A REGULAR BASIS TO DETERMINE IF FURTHER INVESTIGATION IS WARRANTED. A BATCH RECORD REVIEW WAS PERFORMED AND NO ANOMALIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WOULD NOT FIRE PROPERLY. THEY USED A SECOND DEVICE TO COMPLETE THE CASE WITH NO PT CONSEQUENCE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGAMAX-5MM ENDO CLIP APPLIER FZP ETHICON ENDO-SURGERY, INC.(CINCINNATI) NA D4H89C

    Patients

    Seq Age Sex Outcome Treatment
    1