BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX-5MM

    MDR report key: 2142728 · Received June 28, 2011

    Report

    Report Number
    3005075853-2011-02660
    Event Type
    Malfunction
    Date Received
    June 28, 2011
    Date of Event
    June 3, 2011
    Report Date
    June 6, 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
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION WAS REQUESTED. THE ANALYSIS RESULTS FOUND THAT THE DEVICE 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. NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE REPORTED INCIDENT. IN ADDITION, THE DEVICE LOCKED OUT AS INTENDED BUT THE ORANGE VISUAL INDICATOR WAS OVER-TRAVELED. WHEN THIS OCCURS, THE INDICATOR WHEEL MAY CONTINUE TO ROTATE AFTER INDICATION OF A COMPLETELY FIRED DEVICE. PLEASE NOTE THE OVER-TRAVEL OF THE INDICATOR WHEEL IS NOT RELATED TO THE REPORTED EVENT. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPY-ASSISTED DISTAL GASTRECTOMY PROCEDURE, THE DEVICE WAS LOCKED OUT AND THE JAW BECAME NOT TO OPEN. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGAMAX-5MM CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA H4385F

    Patients

    Seq Age Sex Outcome Treatment
    1