BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX-5MM

    MDR report key: 2072967 · Received April 29, 2011

    Report

    Report Number
    3005075853-2011-01792
    Event Type
    Malfunction
    Date Received
    April 29, 2011
    Date of Event
    February 17, 2011
    Report Date
    February 23, 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 Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADVANCER. THE ANALYSIS RESULTS FOUND THAT ONE DEVICE WAS RECEIVED WITH A MALFORMED CLIP IN THE JAWS. THE JAWS WERE CLEARED AND WHEN THE REMAINING CLIPS WERE FIRED. THE CLIPS DID NOT FULLY ADVANCE INTO THE JAW CAUSING CLIPS WITH GAP. THE DEVICE WAS NOTED TO HAVE THE TIP OF THE ADVANCER BENT, THEREFORE CAUSING THE FIRING ISSUES. DURING THE NEXT FIRING SEQUENCE THE TIP OF THE ADVANCER SLID TOWARD TISSUE STOP DUE TO THE CONDITION OF THE ADVANCER. DURING EACH FIRING SEQUENCE THE JAWS REMAINED IN THE CLOSED POSITION. THE TRIGGER WAS MANUALLY ASSISTED IN ORDER TO OPEN THE JAWS. ONE POSSIBLE CAUSE FOR THE CONDITION OF THE ADVANCER IS ACTUATING THE DEVICE WHEN THE JAWS ARE NOT CLEAR OF THE TROCAR. ACTUATING THE DEVICE WITH THE JAWS CLOSED MAY BEND THE ADVANCER. SUBSEQUENT ACTUATIONS OR MANUAL OPENING OF THE DEVICE MAY BEND THE ADVANCER TIP BACK TOWARD ITS ORIGINAL POSITION AND BREAK THE ADVANCER TIP. 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, ON THE SECOND FIRING THE DEVICE JAMMED. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGAMAX-5MM CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA G4U79C

    Patients

    Seq Age Sex Outcome Treatment
    1