BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX 5MM

    MDR report key: 5637833 · Received May 6, 2016

    Report

    Report Number
    3005075853-2016-02544
    Event Type
    Malfunction
    Date Received
    May 6, 2016
    Date of Event
    April 8, 2016
    Report Date
    April 11, 2016
    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
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: THE INITIAL CLIP DID NOT FORM PROPERLY. ONE OF THE LEGS OF THE CLIP STAYED STRAIGHT AND DIDN'T CLAMP TOGETHER. DID DEVICE NOT FEED CLIPS? IT FED CLIPS. DID DEVICE FEED CLIPS SIDEWAYS? INITIAL CLIP FIRED WITH ONE SIDE NOT CLAMPING (FIRST CLIP IS INCLUDED IN RETURNED PRODUCT). DID DEVICE NOT FIRE CLIPS (JAMMED)? NO. DID DEVICE FIRE MALFORMED CLIPS? YES. DID DEVICE FIRE SCISSORED CLIPS? NO. DID DEVICE DROP OR EJECT CLIPS? NO. THE ANALYSIS RESULTS FOUND THAT THE EL5ML DEVICE WAS RETURNED IN GOOD VISUAL CONDITION. IN AN ATTEMPT TO REPLICATE THE REPORTED INCIDENT, THE INSTRUMENT WAS TESTED FOR FUNCTIONALITY. DURING THE ANALYSIS, THE DEVICE WAS CYCLED AND IT FED AND FORMED (B)(4) CLIPS AS INTENDED. IN ADDITION THE DEVICE LOCKED OUT AS INTENDED. DURING FUNCTIONAL TESTING NO MALFORMED CLIPS WERE NOTED. NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE REPORTED INCIDENT. A BATCH RECORD REVIEW WAS PERFORMED AND NO ANOMALIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, THE DEVICE MISFIRED AND DID NOT WORK PROPERLY; SAVED CLIP. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293936 LIGAMAX 5MM CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA N4L60A

    Patients

    Seq Age Sex Outcome Treatment
    1