BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX-5MM ENDO CLIP APPLIER

    MDR report key: 1822607 · Received November 29, 2007

    Report

    Report Number
    1527736-2007-08043
    Event Type
    Malfunction
    Date Received
    November 29, 2007
    Date of Event
    October 28, 2007
    Report Date
    November 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
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL SUMMARY: THE ANALYSIS RESULTS CONFIRMED THAT ONE EL5ML DEVICE WAS RECEIVED IN GOOD VISUAL CONDITION. THE INSTRUMENT WAS CYCLED, FED AND FORMED THE REMAINING CLIPS WITHIN MFG SPECS. THE INSTRUMENT JAWS OPENED AND CLOSED AS INTENDED DURING ANALYSIS. THE INSTRUMENT LOCKED OUT AS INTENDED, BUT THE ORANGE INDICATOR WAS NOTED TO BE BEYOND OF ITS INTENDED POSITION. WHILE NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE REPORTED INCIDENT, 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 MFG PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THE DURING AN UNK PROCEDURE THE DEVICE WAS FIRED ONCE AND THEN IT GOT STUCK AND WOULD NOT FIRE ANYMORE. IT WAS NOT STUCK ON TISSUE. THEY OPENED A NEW DEVICE TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT 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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1