BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX-5MM ENDO CLIP APPLIER

    MDR report key: 1823882 · Received November 30, 2007

    Report

    Report Number
    1527736-2007-08132
    Event Type
    Malfunction
    Date Received
    November 30, 2007
    Date of Event
    October 30, 2007
    Report Date
    November 1, 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
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL SUMMARY: NO CONCLUSION COULD BE REACHED BASED ON THE ANALYSIS RESULTS AS TO WHAT MAY HAVE CAUSED THE REPORTED INCIDENT. THE ANALYSIS RESULT FOR THE EL5ML INSTRUMENT FOUND THAT IT WAS RETURNED EMPTY AND LOCKED OUT, BUT THE ORANGE INDICATOR DID NOT SHOW UP. THE INSTRUMENT IS DESIGNED TO LOCKOUT WHEN ALL THE CLIPS HAVE BEEN FIRED. NO TESTING COULD BE PERFORMED AS THE INSTRUMENT WAS RETURNED EMPTY. WHILE WE WERE UNABLE TO RECREATE THE EVENT, 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

    THE CUSTOMER REPORTS THAT DURING A LAP CHOLECYSTECTOMY PROCEDURE, THE ER220 DEVICE THE CLIP JAW WAS MISALIGNED. THE CLIPS JAMMED AND DOUBLED UP ON THE LIGAMAX DEVICE. THEY GOT NEW DEVICES TO COMPLETE THE PROCEDURE. THERE WAS NO PT CONSEQUENCE. BOTH DEVICES WILL BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGAMAX-5MM ENDO CLIP APPLIER FZP ETHICON ENDO SURGERY, INC. (CINCINNATI) NA D4J71V

    Patients

    Seq Age Sex Outcome Treatment
    1