BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX-5MM ENDO CLIP APPLIER

    MDR report key: 3140650 · Received May 31, 2013

    Report

    Report Number
    3005075853-2013-02721
    Event Type
    Malfunction
    Date Received
    May 31, 2013
    Date of Event
    May 10, 2013
    Report Date
    May 12, 2013
    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
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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. THE ROTATIONAL KNOB TURN WITHOUT ANY ISSUE. IN ADDITION THE DEVICE LOCKED OUT AS INTENDED BUT THE ORANGE INDICATOR WAS FOUND UNDERTRAVELED; IN ORDER TO EVALUATE THE CONDITION OF THE INTERNAL COMPONENTS THE DEVICE WAS DISASSEMBLED. UPON DISASSEMBLING, NO ANOMALIES WERE FOUND. PLEASE NOTE THAT THIS CONDITION IS UNRELATED WITH THE REPORT INCIDENT. 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). DATE SENT: (B)(4) 2013. INFORMATION WAS NOT PROVIDED BY THE INITIAL CONTACT. INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, THERE WAS DIFFICULTY TURNING THE ROTATING KNOB ON THE DEVICE WITH ONE FINGER/HAND. THE CLIPS DID NOT STAY COMPLETELY ACROSS THE CYSTIC DUCT AND SOME CLIPS CROSSED OVER EACH OTHER. THE SURGEON USED AN ER420 TO COMPLETE THE CASE. THERE WERE NO PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    241338 LIGAMAX-5MM ENDO CLIP APPLIER CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA K4CJ6F

    Patients

    Seq Age Sex Outcome Treatment
    1