BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX-5MM

    MDR report key: 1934030 · Received December 21, 2010

    Report

    Report Number
    3005075853-2010-07306
    Event Type
    Malfunction
    Date Received
    December 21, 2010
    Date of Event
    November 29, 2010
    Report Date
    November 30, 2010
    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
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: THE SURGEON TRIGGERED THE DEVICE, WHEN TRIGGERED IT, THE DEVICE STAYED CLIPPED ON THE TISSUE. THEY WERE ABLE TO GET IT OFF THE TISSUE. THE CLIP WAS NOT UNIFORMED ON VESSEL. THEREFORE THEY REMOVED THE CLIP AND PUT NEW ONE ON. THERE WAS NO DAMAGE TO THE TISSUE. 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 INDICATOR INDEXED TWO TIMES DURING THE 15TH FIRING SEQUENCE, THUS, IT OVER TRAVELED. THIS FINDING IS NOT RELATED WITH THE INCIDENT REPORTED. 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 PROCEDURE, THE DEVICE WAS BEING USED TO CLIP THE VESSEL DUCT. THE DEVICE REMAINED CLIPPED; THEY WERE ABLE TO REMOVE IT. THEY HAD TO REMOVE THE CLIP. ANOTHER DEVICE WAS OPENED AND USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT IMPACT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGAMAX-5MM CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA G4TJ9Z

    Patients

    Seq Age Sex Outcome Treatment
    1