BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX-5MM ENDO CLIP APPLIER

    MDR report key: 1915572 · Received February 12, 2008

    Report

    Report Number
    1527736-2008-00847
    Event Type
    Malfunction
    Date Received
    February 12, 2008
    Date of Event
    January 23, 2008
    Report Date
    January 23, 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
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION 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 (B)(4) 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 INFORMATION 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 CHOLE PROCEDURE, THE FIRST DEVICE WAS BEING FIRED ON THE CYSTIC DUCT, WHICH WAS FAT AND SWOLLEN. THE FIRST FOUR CLIPS WOULD NOT CLOSE, THIS MAY HAVE BEEN DUE TO THE DUCT BEING SWOLLEN. A SECOND DEVICE WAS OPENED, BUT THE FIRST CLIP WOULD NOT FIRE AND WHEN TRYING TO FIRE A SECOND TIME, THE CLIP CLIPPED ON THE FIRST CLIP INSIDE THE JAWS. AN ENDOLOOP WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT CONSEQUENCE. ONLY THE SECOND DEVICE 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 D4JT9X

    Patients

    Seq Age Sex Outcome Treatment
    1