BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX-5MM ENDO CLIP APPLIER

    MDR report key: 1930628 · Received December 16, 2010

    Report

    Report Number
    3005075853-2010-07215
    Event Type
    Malfunction
    Date Received
    December 16, 2010
    Date of Event
    September 29, 2010
    Report Date
    October 5, 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). THE ANALYSIS RESULTS OF THE DEVICE (A) FOUND THAT IT 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 THE TISSUE STOP DURING THE CONSECUTIVE FIRING SEQUENCES CAUSING THE JAWS TO REMAIN IN THE CLOSED POSITION. THE TRIGGER WAS MANUALLY ASSISTED IN ORDER TO OPEN THE JAWS WITHOUT ANY DIFFICULTIES; PEAR SHAPED CLIPS WERE RELEASED. DURING THE NEXT FIRING SEQUENCE THE CLIP WAS FORMED AS CONFORMING. THE DEVICE LOCKED OUT AS INTENDED BUT THE ORANGE INDICATOR DID NOT SHOW UP. IT COULD NOT BE DETERMINED WHAT MAY HAVE CAUSED THE REPORTED EVENT. IT SHOULD BE NOTED THAT 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. A BATCH RECORD REVIEW WAS PERFORMED AND NO ANOMALIES WERE FOUND DURING THE MANUFACTURING PROCESS. THE ANALYSIS RESULTS FOUND THAT ONE DEVICE (B) WAS RECEIVED 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. IN ADDITION, THE DEVICE LOCKED OUT AS INTENDED BUT THE ORANGE INDICATOR WAS NOT VISIBLE; THIS FINDING IS NOT RELATED WITH THE EVENT REPORTED. A BATCH RECORD REVIEW WAS PERFORMED AND NO ANOMALIES WERE FOUND DURING THE MANUFACTURING PROCESS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE DEVICE WAS SENDING OUT MULTIPLE CLIPS ON EACH FIRING. THEY OPENED A NEW ONE AND IT DID THE SAME THING. THEY THEN CHANGED TO A DIFFERENT DEVICE WHICH WORKED FINE. 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. NA G4T91G

    Patients

    Seq Age Sex Outcome Treatment
    1