BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX CLIP APPLIER

    MDR report key: 4200690 · Received October 24, 2014

    Report

    Report Number
    3005075853-2014-07354
    Event Type
    Malfunction
    Date Received
    October 24, 2014
    Date of Event
    September 12, 2014
    Report Date
    October 6, 2014
    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
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: THE ANALYSIS RESULTS FOUND THAT THE EL5ML 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 THIRTEEN CONFORMING CLIPS. IN ORDER TO CONFIRM THE CLIPS WERE WITHIN MANUFACTURING SPECIFICATIONS, THE CLIPS WERE EVALUATED USING A TOOL THAT IS DESIGNED TO DETERMINE PROPER FORMATION. IN ADDITION THE DEVICE LOCKED OUT AS INTENDED. 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.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, THE CLIPS WERE NOT CLOSING TIGHTLY, THEY WERE FALLING OFF OF THE VESSEL/DUCT AND OUT OF THE DEVICE. THERE WERE NO PATIENT CONSEQUENCES. CASE COMPLETED WITH ANOTHER DEVICE OF THE SAME PRODUCT CODE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    679544 LIGAMAX CLIP APPLIER CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA L4EV1E

    Patients

    Seq Age Sex Outcome Treatment
    1