BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX-5MM ENDO CLIP APPLIER

    MDR report key: 1830326 · Received September 20, 2007

    Report

    Report Number
    1527736-2007-06238
    Event Type
    Malfunction
    Date Received
    September 20, 2007
    Report Date
    July 30, 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
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL SUMMARY: THE ANALYSIS RESULTS FOR THE EL5ML INSTRUMENT CONFIRMED THAT IT WAS RETURNED NON-FUNCTIONAL. THE INSTRUMENT WAS RETURNED EMPTY AND LOCKED OUT, BUT THE ORANGE INDICATOR WAS NOT SHOWING UP. THE INSTRUMENT IS DESIGNED TO LOCKOUT WHEN ALL THE CLIPS HAVE BEEN FIRED AND THE ORANGE INDICATOR MUST BE VISILE AFTER THE 13TH CLIP IS FIRED. IN ADDITION, THE RAMP OF ONE SIDE OF THE JAWS AND THE CAM WERE NOTED TO BE BROKEN. NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE INDICATOR ISSUE. 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 LOCKED, AND DID NOT RELEASE THE CLIPS DURING THE PROCEDURE. NO FURTHER INFO WAS PROVIDED. THERE WAS NO PATIENT 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 D4H67L

    Patients

    Seq Age Sex Outcome Treatment
    1