BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX-5MM ENDO CLIP APPLIER

    MDR report key: 1171537 · Received September 18, 2008

    Report

    Report Number
    3005075853-2008-01775
    Event Type
    Malfunction
    Date Received
    September 18, 2008
    Date of Event
    August 12, 2008
    Report Date
    August 22, 2008
    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
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADVANCER. EVAL SUMMARY: THE ANALYSIS RESULTS FOUND THAT THE EL5ML DEVICE WAS RETURNED WITH THE TIP OF THE ADVANCER BROKEN. THE INSTRUMENT WAS CYCLED AND PEAR SHAPED THE REMAINING CLIPS DUE TO THE ADVANCER CONDITION. 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." 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. 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 LAP HERNIA PROCEDURE, THE DEVICE MIS-FED. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGAMAX-5MM ENDO CLIP APPLIER FZP ETHICON ENDO-SURGERY, LLC NA E4LA4H

    Patients

    Seq Age Sex Outcome Treatment
    1