BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX-5MM ENDO CLIP APPLIER

    MDR report key: 1190503 · Received October 9, 2008

    Report

    Report Number
    1527736-2008-03430
    Event Type
    Malfunction
    Date Received
    October 9, 2008
    Date of Event
    December 5, 2007
    Report Date
    January 25, 2008
    Manufacturer
    ETHICON ENDO SURGERY, INC. (CINCINNATI)
    Product Code
    GDO
    PMA / PMN Number
    K050344
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT: 06/03/2008. THE ANALYSIS RESULTS FOUND THAT THE EL5ML DEVICE WAS RECEIVED IN GOOD VISUAL CONDITION AND WITH A "J" CLIP ON THE JAWS, THE ROOT CAUSE OF A J-SHAPED MALFORMED CLIP IS FEEDING THE CLIP INTO A CLOSED SET OF JAWS. THE FOLLOWING ARE SCENARIOS OF HOW THIS MALFORMED CLIP COULD HAVE HAPPENED: HAVING THE JAWS CLOSED IN A TROCAR AND ACTUATING THE TRIGGER. HAVING THE JAWS CLOSED IN THE MOLDED ENDCAP AND ACTUATING THE TRIGGER. HAVING THE JAWS CLOSED BY BURYING TIPS IN TISSUE AND ACTUATING THE TRIGGER. IT SHOULD BE NOTED THAT THE JAWS NEED TO BE FULLY OPEN IN ORDER FOR THE NEXT CLIP TO BE PROPERLY FED. THE INSTRUMENT WAS CYCLED, FED AND FORMED THE REMAINING CLIPS WITHIN MFG SPECIFICATIONS. THE INSTRUMENT LOCKED OUT AS INTENDED AND IT OPENED AND CLOSED WITHOUT ANY DIFFICULTIES. HOWEVER, THE JAWS WERE NOTED TO BE OUT OF ACCEPTABLE LIMITS, THE DEVICE WAS DISSASSEMBLED AND NO ANOMALIES WERE FOUND. WHILE WE WERE UNABLE TO RE-CREATE 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. NO INCIDENT RELATED TO THE REPORTED EVENT WAS OBSERVED DURING THE BATCH RECORD REVIEW.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY. THE DEVICE FAILED. UNK HOW CASE COMPLETED. THERE WAS NO CONSEQUENCE TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGAMAX-5MM ENDO CLIP APPLIER NONE GDO ETHICON ENDO SURGERY, INC. (CINCINNATI) NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1