BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX-5MM

    MDR report key: 1972446 · Received January 28, 2011

    Report

    Report Number
    3005075853-2011-00329
    Event Type
    Malfunction
    Date Received
    January 28, 2011
    Date of Event
    December 30, 2010
    Report Date
    January 6, 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
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4). ADVANCER BYPASS; JAWS. THE DEVICE WAS RECEIVED IN GOOD VISUAL CONDITION. IN AN ATTEMPT TO REPLICATE THE REPORTED INCIDENT, THE DEVICE WAS TESTED FOR FUNCTIONALITY. UPON FIRING, THE TIP OF THE ADVANCER SLID TOWARD TISSUE STOP DURING THE CONSECUTIVE FIRING SEQUENCE CAUSING THE JAWS REMAINED IN THE CLOSED POSITION. THE TRIGGER WAS MANUALLY ASSISTED IN ORDER TO OPEN THE JAWS WITHOUT ANY DIFFICULTIES; PEAR SHAPED CLIPS WAS RELEASED. IT SHOULD BE NOTED THAT AN INVESTIGATION HAS BEEN INITIATED TO ADDRESS THE POTENTIAL ROOT CAUSE OF THE ADVANCER BYPASS ISSUES. DURING THE NEXT FIRING SEQUENCE THREE CLIPS WITH GAP WERE DELIVERED; HOWEVER, IT COULD NOT BE DETERMINED WHAT MAY HAVE CAUSED THIS CONDITION. THE REMAINING CLIPS WERE FIRED CONFORMING AND THE DEVICE LOCKED OUT AS INTENDED BUT THE ORANGE INDICATOR WAS NOT VISIBLE. AN INVESTIGATION WAS INITIATED TO ADDRESS THE POTENTIAL ROOT CAUSE OF JAW OPENING ISSUES. DURING THIS INVESTIGATION ADVANCER BYPASS WAS IDENTIFIED AS ONE POTENTIAL ROOT CAUSE; THEREFORE, ADVANCER BYPASS IS BEING EVALUATED IN THIS INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, THE SURGEON DRY FIRED THE DEVICE BEFORE PUTTING IN THE PATIENT. THE HANDLES IMMEDIATELY BECAME STUCK. CONCERNED TO USE THE DEVICE THE SURGEON ASKED FOR A SECOND DEVICE. THE DEVICE WAS NEVER FIRED ON THE PATIENT. NOTHING WAS MENTIONED ABOUT THE CLIPS. THE SECOND DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGAMAX-5MM CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA G4U05A

    Patients

    Seq Age Sex Outcome Treatment
    1