BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX-5MM ENDO CLIP APPLIER

    MDR report key: 1820270 · Received September 26, 2007

    Report

    Report Number
    1527736-2007-06351
    Event Type
    Malfunction
    Date Received
    September 26, 2007
    Report Date
    August 3, 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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EMPTY INSTRUMENT, BROKEN JAW. EVALUATION SUMMARY: THE ANALYSIS RESULT FOR THE INSTRUMENT FOUND THAT IT WAS RETURNED WITH THE JAW BROKEN AT BIFURCATION, EMPTY AND WITH THE LOCKOUT MECHANISM FIRED THROUGH. THE INSTRUMENT IS DESIGNED TO LOCKOUT WHEN ALL THE CLIPS HAVE BEEN FIRED. HOWEVER, IT WAS NOTED THAT THE ORANGE INDICATOR WAS BEYOND ITS INTENDED POSITION DUE TO THE LOCKOUT MECHANISM BEING FIRED THROUGH. NO CONCLUSION COULD BE REACHED BASED ON THE ANALYSIS RESULTS AS TO WHAT MAY HAVE CAUSED THE REPORTED INCIDENT. 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. NO INCIDENT RELATED TO THE REPORTED EVENT WAS OBSERVED DURING THE BATCH RECORD REVIEW.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNK PROCEDURE, THE DEVICE LOCKED OUT. USED ANOTHER LIKE DEVICE TO COMPLETE THE CASE. NO PT CONSEQUENCE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1