BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX-5MM ENDO CLIP APPLIER

    MDR report key: 3181559 · Received June 21, 2013

    Report

    Report Number
    3005075853-2013-03179
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Date of Event
    June 10, 2013
    Report Date
    June 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
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: HOW WAS THE DEVICE REMOVED FROM TISSUE? THE JAW DID NOT CLAMP THE TISSUE WHEN THE EVENT OCCURRED. WAS THERE ANY TISSUE DAMAGE? IF SO PLEASE EXPLAIN. NO. WERE THERE ANY UNUSUAL NOISES HEARD? NO. WAS THERE ANY TORQUING OR TWISTING WHILE FIRING THE DEVICE? NO. WAS THE DEVICE DIFFICULT TO FIRE? NO. 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. DURING ANALYSIS THE JAWS OPEN AND CLOSE AS INTENDED. 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). 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 SIGMOID RESECTION PROCEDURE, THE JAWS DID NOT OPEN AFTER THE 3RD FIRING. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282222 LIGAMAX-5MM ENDO CLIP APPLIER CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA K4CF1D

    Patients

    Seq Age Sex Outcome Treatment
    1