BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX-5MM ENDO CLIP APPLIER

    MDR report key: 1820616 · Received September 13, 2007

    Report

    Report Number
    1527736-2007-06074
    Event Type
    Malfunction
    Date Received
    September 13, 2007
    Date of Event
    June 29, 2007
    Report Date
    July 5, 2007
    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
    AS
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MALFORMED CLIP. EVALUATION SUMMARY: THE ANALYSIS RESULTS FOUND THAT THE EL5ML DEVICE WAS RETURNED IN GOOD VISUAL CONDITION. THE INSTRUMENT WAS CYCLED AND THE ADVANCER BYPASSED THE CLIPS CAUSING 3 PEAR SHAPED CLIPS. THE INSTRUMENT LOCKED OUT BUT THE ORANGE INDICATOR WAS BEYOND OF ITS INTENDED POSITION. A CORRECTIVE ACTION HAS BEEN INITIATED TO ADDRESS THE ROOT CAUSE OF THE BYPASS ISSUES. 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 CHOLECYSTECTOMY PROCEDURE, THE CLIP APPLIER WOULD NOT CLOSE DOWN ON THE CLIPS ON THE FIRST AND SECOND FIRINGS. USED A NEW INSTRUMENT. THERE WAS NO PT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGAMAX-5MM ENDO CLIP APPLIER FZP ETHICON ENDO SURGERY, INC (CINCINNATI) NA D4HD1R

    Patients

    Seq Age Sex Outcome Treatment
    1