BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX-5MM ENDO CLIP APPLIER

    MDR report key: 1250818 · Received December 2, 2008

    Report

    Report Number
    3005075853-2008-03378
    Event Type
    Malfunction
    Date Received
    December 2, 2008
    Date of Event
    October 30, 2008
    Report Date
    November 10, 2008
    Manufacturer
    ETHICON ENDO-SURGERY, LLC
    Product Code
    FZP
    PMA / PMN Number
    K050344
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). (B) (4). EMPTY. EVALUATION SUMMARY: THE ANALYSIS RESULTS FOUND THAT THE EL5ML DEVICE (A) WAS RECEIVED IN GOOD VISUAL CONDITION. IT WAS TESTED FOR FUNCTIONALITY AND IT DID OPEN AND CLOSE WITHOUT ANY DIFFICULTIES. IN ADDITION, IT WAS CYCLED, FED, AND FORMED THE REMAINING 10 CLIPS CONFORMING. THE DEVICE LOCKED OUT AS INTENDED. THE REPORTED INCIDENT COULD NOT BE DUPLICATED, AS THE INSTRUMENT WAS FULLY FUNCTIONAL. THE ANALYSIS RESULT FOR THE EL5ML INSTRUMENT (B) FOUND THAT IT WAS RETURNED EMPTY AND LOCKED OUT, BUT THE ORANGE INDICATOR WAS NOTED TO BE BEYOND ITS INTENDED POSITION. THE INSTRUMENT IS DESIGNED TO LOCKOUT WHEN ALL THE CLIPS HAVE BEEN FIRED. NO TESTING COULD BE PERFORMED AS THE INSTRUMENT WAS RETURNED EMPTY. 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 HISTORY RECORDS WERE REVIEWED WITH NO ANOMALIES NOTED DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE, THE CLIP WOULD NOT HOLD. THERE WAS NO ADVERSE PT CONSEQUENCE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGAMAX-5MM ENDO CLIP APPLIER FZP ETHICON ENDO-SURGERY, LLC NA D4GT1J

    Patients

    Seq Age Sex Outcome Treatment
    1