BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX-5MM ENDO CLIP APPLIER

    MDR report key: 1130391 · Received August 20, 2008

    Report

    Report Number
    1527736-2008-03942
    Event Type
    Malfunction
    Date Received
    August 20, 2008
    Date of Event
    May 19, 2008
    Report Date
    May 21, 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
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE ANALYSIS RESULTS FOUND THAT THE DEVICE WAS RECEIVED IN GOOD VISUAL CONDITION. THE DEVICE WAS TESTED FOR FUNCTIONALITY AND IT FIRED 8 CLIPS CONFORMING AND ONE DOUBLE FEED. THE DEVICE WAS DISASSEMBLED AND NO ANOMALIES WERE FOUND WITH THE INTERNAL COMPONENTS. NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE FIRING ISSUE. 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 MFG PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING A CHOLECYSTECTOMY PROCEDURE THAT THE CLIP DID NOT FEED INTO THE JAW PROPERLY AFTER THE SECOND FIRING. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGAMAX-5MM ENDO CLIP APPLIER FZP ETHICON ENDO-SURGERY, INC (CINCINNATI) NA E4KJ8Z

    Patients

    Seq Age Sex Outcome Treatment
    1