BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX-5MM

    MDR report key: 2141800 · Received June 27, 2011

    Report

    Report Number
    3005075853-2011-02606
    Event Type
    Malfunction
    Date Received
    June 27, 2011
    Date of Event
    May 25, 2011
    Report Date
    June 3, 2011
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    FZP
    PMA / PMN Number
    K050344
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4). EMPTY THE ANALYSIS RESULTS FOUND THAT DEVICE (A) WAS RECEIVED IN GOOD VISUAL CONDITION. WHEN TESTING THE DEVICE FOR FUNCTIONALITY IT WAS NOTED TO BE EMPTY AND LOCKED OUT. DUE TO THE CONDITION OF THE DEVICE, NO FUNCTIONAL TESTING COULD BE PERFORMED TO EVALUATE THE REPORTED INCIDENT. THE ANALYSIS RESULTS FOUND THAT DEVICE (B) WAS RETURNED IN GOOD VISUAL CONDITION. IN AN ATTEMPT TO REPLICATE THE REPORTED INCIDENT, THE DEVICE WAS TESTED FOR FUNCTIONALITY. UPON TESTING, THE DEVICE WAS CYCLED, FED, AND FORMED THE REMAINING CLIPS AS INTENDED. THE DEVICE WAS FOUND TO BE FULLY FUNCTIONAL AND CONFORMING TO OUR MANUFACTURING SPECIFICATIONS. NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE REPORTED INCIDENT. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICES WERE USED DURING AN UNKNOWN PROCEDURE. THE CLIPS WOULD NOT CLOSE WELL AND OTHERS FELL OFF AFTER BEING APPLIED TO THE VESSEL. UNKNOWN HOW THE CASE WAS COMPLETED. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGAMAX-5MM CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA H4360P

    Patients

    Seq Age Sex Outcome Treatment
    1