BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX 5MM ENDO CLIP APPLIER

    MDR report key: 863814 · Received June 11, 2007

    Report

    Report Number
    1527736-2007-04036
    Event Type
    Malfunction
    Date Received
    June 11, 2007
    Date of Event
    May 6, 2007
    Report Date
    May 11, 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
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFO WAS NOT PROVIDED BY THE INITIAL CONTACT. INSTRUMENT A: STICKING JAW/CAM. INSTRUMENT B. INSTRUMENT C AND D: BATCH #D9DJ17; EXPIRATION DATE: 03/04/2011; (MALFORMED CLIP); 47 INSTRUMENT E: D4: BATCH # D9DK25: EXPIRATION DATE: 03/13/2012; (MALFORMED CLIP) 47 INSTRUMENT F: D4: BATCH # D9DK25: EXPIRATION DATE: 03/13/2012; (MALFORMED CLIP) 47 INSTRUMENT F: D4: BATCH # D9DL25: EXPIRATION DATE: 03/13/2012; THE ANALYSIS RESULTS CONFIRMED THAT ONE EL5ML DEVICE (A) WAS RECEIVED IN GOOD VISUAL CONDITION. THE INSTRUMENT WAS CYCLED, FED AND FORMED THE REMAINING CLIPS WITHIN MFG SPECIFICATIONS. HOWEVER, STICKING JAW ISSUES WERE NOTED DURING FUNCTIONAL ANALYSIS. NO INCIDENT RELATED TO THE REPORTED EVENT WAS OBSERVED DURING THE BATCH RECORD REVIEW. THE ANALYSIS RESULTS CONFIRMED THAT ONE EL5ML DEVICE (B) WAS RECEIVED IN GOOD VISUAL CONDITION. THE INSTRUMENT WAS CYCLED, FED AND FORMED THE REMAINING CLIPS WITHIN MFG SPECIFICATIONS. NO INCIDENT RELATED TO THE REPORTED EVENT WAS OBSERVED DURING THE BATCH RECORD REVIEW. THE ANALYSIS RESULTS FOR THE EL5ML INSTRUMENT (C) CONFIRMED THAT IT WAS NON-FUNCTIONAL. THE INSTRUMENT WAS CYCLED AND DOUBLE FED THE CLIPS, CAUSING TWO PEAR SHAPED CLIPS AND THE REMAINING NINE CLIPS WERE PROPERLY FED AND FORMED. NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE FEEDING ISSUE. OUR MFG BATCH HISTORY REVIEW IDENTIFIED THAT A DOUBLE FED ISSUE WAS DETECTED DURING THE MFG OF THIS BATCH. WHEN THIS OCCURS, OUR QUALITY SYSTEM DOCUMENTS THE NECESSARY ACTIONS TO ENSURE FINAL PRODUCT QUALITY. THE FINAL QUALITY RELEASE CRITERIA WAS MET BEFORE THIS BATCH WAS RELEASED FOR DISTRIBUTION. THE ANALYSIS RESULTS FOR THE EL5ML INSTRUMENT (D) FOUND THAT IT WAS RETURNED NON-FUNCTIONAL. THE INSTRUMENT WAS CYCLED AND FED FIVE CLIPS WITH GAB AND TWO CONFORMING CLIPS. NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE FEEDING ISSUE. NO INCIDENT RELATED TO THE REPORTED EVENT WAS OBSERVED DURING THE BATCH RECORD REVIEW. THE ANALYSIS RESULTS FOUND THAT THE EL5ML DEVICE (E) WAS RETURNED IN GOOD VISUAL CONDITION. THE INSTRUMENT WAS CYCLED AND A DOUBLE FED ISSUE WAS NOTED, CAUSING 3 PEAR SHAPED CLIPS, THE FOLLOWING FIRING CAUSED A CLIP WITH GAP AND THE REMAINING 7 CLIPS WERE PROPERLY FED AND FORMED. OUR MFG BATCH HISTORY REVIEW IDENTIFIED THAT A DOUBLE FED ISSUE WAS DETECTED DURING THE MFG OF THIS BATCH. WHEN IT OCCURS, OUR QUALITY SYSTEM DOCUMENTS THE NECESSARY ACTIONS TO ENSURE FINAL PRODUCT QUALITY. THE FINAL QUALITY RELEASE CRITERIA WAS MET BEFORE THIS BATCH WAS RELEASED FOR DISTRIBUTION. THE ANALYSIS RESULTS CONFIRMED THAT ONE EL5ML DEVICE (F) WAS RECEIVED IN GOOD VISUAL CONDITION. THE INSTRUMENT WAS CYCLED, FED AND FORMED THE REMAINING CLIPS WITHIN MFG SPECIFICATIONS. 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 CLIPS ARE COMING OUT SIDEWAYS, THE CUSTOMER USED ANOTHER LIKE DEVICE TO COMPLETE THE CASE WITH NO PT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGAMAX 5MM ENDO CLIP APPLIER FZP FZP ETHICON ENDO-SURGERY, INC. (CINCINNATI) NA D4GW9V

    Patients

    Seq Age Sex Outcome Treatment
    1 YR