BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX-5MM ENDO CLIP APPLIER

    MDR report key: 1831694 · Received September 12, 2007

    Report

    Report Number
    1527736-2007-06020
    Event Type
    Malfunction
    Date Received
    September 12, 2007
    Date of Event
    August 9, 2007
    Report Date
    August 15, 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
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE ANALYSIS RESULTS CONFIRMED THAT THE EL5ML DEVICE (A) WAS RECEIVED NON-FUNCTIONAL. THE INSTRUMENT WAS CYCLED, FED AND FORMED PROPERLY THE CLIPS. HOWEVER, THE INSTRUMENT WAS NOTED TO HAVE STICKING ISSUES. A CORRECTIVE ACTION HAS BEEN INITIATED TO ADDRESS THE ROOT CAUSE OF THE STICKING ISSUE. THE ANALYSIS RESULTS CONFIRMED THAT ONE EL5ML DEVICE (B) WAS RECEIVED IN GOOD VISUAL CONDITION. THE INSTRUMENT WAS CYCLED AND UPON THE FIRST FIRING A DOUBLE FED ISSUE WAS NOTED, THE SUBSEQUENT FIRINGS RESULTED IN 6 CONFORMING CLIPS. HOWEVER, THE JAWS OPENED AND CLOSED AS INTENDED. 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 THE TRIGGER WOULD NOT OPEN. THE CUSTOMER USED A THIRD DEVICE TO COMPLETE THE CASE WITH NO PATIENT CONSEQUENCE. THE DEVICES ARE AVAILABLE FOR ANALYSIS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1