BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX-5MM ENDO CLIP APPLIER

    MDR report key: 2013438 · Received March 10, 2011

    Report

    Report Number
    3005075853-2011-00975
    Event Type
    Malfunction
    Date Received
    March 10, 2011
    Date of Event
    November 19, 2010
    Report Date
    November 25, 2010
    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
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) = ADVANCER. THE DEVICE WAS RECEIVED IN GOOD VISUAL CONDITION. IN AN ATTEMPT TO REPLICATE THE REPORTED INCIDENT, THE DEVICE WAS TESTED FOR FUNCTIONALITY. UPON FIRING OF THE DEVICE, THE TIP OF THE ADVANCER SLID TOWARD TISSUE STOP DURING THE FIRST FIRING SEQUENCE CAUSING THAT THE JAWS REMAINED IN THE CLOSED. THE TRIGGER WAS MANUALLY ASSISTED IN ORDER TO OPEN THE JAWS WITHOUT ANY DIFFICULTIES NOTED; A PEAR SHAPED CLIP WAS RELEASED. 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. THE REMAINING CLIPS WERE CONFORMING ACCORDING TO OUR MANUFACTURING SPECIFICATIONS AND THEN IT LOCKED OUT AS INTENDED BUT THE ORANGE INDICATOR WAS NOT VISIBLE; HOWEVER, THIS FINDING IS NOT RELATED WITH THE INCIDENT REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, THE DEVICE JAMMED. THE CLIPS IN THE JAWS ARE DISTORTED AND COULD NOT LOAD CORRECTLY. UNKNOWN HOW CASE WAS COMPLETED. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGAMAX-5MM ENDO CLIP APPLIER CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. UNK G4TV5P

    Patients

    Seq Age Sex Outcome Treatment
    1