BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX CLIP APPLIER

    MDR report key: 3875193 · Received June 16, 2014

    Report

    Report Number
    3005075853-2014-04025
    Event Type
    Malfunction
    Date Received
    June 16, 2014
    Date of Event
    May 9, 2014
    Report Date
    May 12, 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
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: INDICATOR WHEEL FAILURE, MALFORMED CLIP. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: WHAT WAS SPECIFIC PRODUCT ISSUE? --- THE CLIP WAS NOT FED INTO THE JAWS PROPERLY, AND THEN SOME CLIPS CAME OUT AT A FIRING. WHAT TYPE OF FEEDING ISSUE WAS OBSERVED (EX. SIDEWAYS FEED, MULTIPLE FEED, ETC)? --- MULTIPLE FEED. DID THE DEVICE DELIVER ANY CLIPS? --- YES. IF YES, WERE THE CLIPS FORMED PROPERLY? --- NO. DID THE DEVICE DROP/EJECT CLIPS? --- NO. IF YES, DID ANY CLIPS FALL INTO THE PATIENT? WERE CLIPS RETRIEVED? --- NA. 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 THE REMAINING 12 CLIPS AS INTENDED. IN ORDER TO CONFIRM THE CLIPS WERE WITHIN MANUFACTURING SPECIFICATIONS, THE CLIPS WERE EVALUATED USING A TOOL THAT IS DESIGNED TO DETERMINE PROPER FORMATION. DURING ANALYSIS THE JAWS OPENED AND CLOSED AS INTENDED. IN ADDITION THE DEVICE LOCKED OUT AS INTENDED, HOWEVER, THE ORANGE INDICATOR WAS NOTED UNDERTRAVELED. PLEASE NOTE THAT THIS FINDING IS NOT RELATED WITH THE INCIDENT REPORTED. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC ILEOCECAL PROCEDURE, CLIPS CAME OUT AT A TIME FROM THE 1ST FIRING. THE DEVICE DID NOT CLAMP SOMETHING HARD SUCH AS AN EXISTING CLIP. THERE WAS NO UNEXPECTED NOISE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THE DEVICE WAS FIRED SEVERAL TIMES OUT OF THE PATIENT AFTER THE EVENT AND THE SAME EVENT WAS RECREATED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ONE DEVICE WILL BE RETURNING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352482 LIGAMAX CLIP APPLIER CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA L90D99

    Patients

    Seq Age Sex Outcome Treatment
    1