BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX-5MM

    MDR report key: 2042608 · Received April 6, 2011

    Report

    Report Number
    3005075853-2011-01389
    Event Type
    Malfunction
    Date Received
    April 6, 2011
    Date of Event
    March 12, 2011
    Report Date
    March 14, 2011
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    FZP
    PMA / PMN Number
    K050344
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION WAS NOT PROVIDED BY THE INITIAL CONTACT. 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 CLIPS AS INTENDED. NO OPENING ISSUES WERE NOTED DURING EVALUATION; THE DEVICE WAS FOUND TO BE FULLY FUNCTIONAL AND CONFORMING TO OUR MANUFACTURING SPECIFICATIONS. NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE REPORTED INCIDENT. IN ADDITION, THE DEVICE LOCKED OUT AS INTENDED BUT THE ORANGE VISUAL INDICATOR WAS OVER-TRAVELED. WHEN THIS OCCURS, THE INDICATOR WHEEL MAY CONTINUE TO ROTATE AFTER INDICATION OF A COMPLETELY FIRED DEVICE. PLEASE NOTE THE OVER-TRAVEL OF THE INDICATOR WHEEL IS NOT RELATED TO THE REPORTED EVENT. 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 CHOLECYSTECTOMY PROCEDURE THE DEVICE LOCKED ON THE CYSTIC DUCT. THEY REMOVED THE DEVICE BY PULLING ON THE HANDLES APART AND SPRINGING THE JAWS LOOSE. THERE WAS NO DAMAGE TO THE TISSUE REPORTED. THEY COMPLETED THE PROCEDURE WITH A NEW LIKE DEVICE. THERE WAS NO PATIENT CONSEQUENCE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGAMAX-5MM CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA H4354K

    Patients

    Seq Age Sex Outcome Treatment
    1