BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP*MCA

    MDR report key: 1831608 · Received September 12, 2010

    Report

    Report Number
    3005075853-2010-05203
    Event Type
    Malfunction
    Date Received
    September 12, 2010
    Date of Event
    August 18, 2010
    Report Date
    August 18, 2010
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDO
    PMA / PMN Number
    K820837
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NON-CONFORMING FEED THE ANALYSIS RESULTS FOUND THAT THE DEVICE WAS RETURNED IN GOOD VISUAL CONDITION. IN AN ATTEMPT TO REPLICATE THE REPORTED INCIDENT, THE DEVICE WAS TESTED FOR FUNCTIONALITY. UPON TESTING OF THE DEVICE, IT FED THE CLIPS INTERMITTENTLY. IN ORDER TO EVALUATE THE DEVICE'S INTERNAL COMPONENTS IT WAS DISASSEMBLED. UPON EVALUATION OF THE DEVICE, THE FEEDER SHOE WAS FOUND TO BE JAMMED LEADING THE FOUND FEEDING ISSUES. HOWEVER, IT COULD NOT BE DETERMINED WHAT MAY HAVE CAUSED THE FOUND CONDITION. PLEASE PRIOR TO EACH CLIP APPLICATION, INSPECT THE JAWS TO ENSURE THE CLIP IS FULLY ADVANCED TO THE TIP OF THE JAWS. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    Additional Manufacturer Narrative · 1

    (B)(4): INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS RECEIVED: THE SURGEON STATED THE PROBLEM OCCURRED BECAUSE THE CLIP APPLIER WAS NOT PRELOADED ON THE BACK TABLE PRIOR TO HANDING OFF THE DEVICE. THUS, WITH NO CLIP IN THE JAWS, THE DEVICE SEVERED THE ARTERY. THE PATIENT IS DOING FINE. (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A ROBOTIC LYMPH NODE DISSECTION PROCEDURE, THE SURGEON NOTICED COLON CANCER SO PROCEEDED TO OPEN THE PATIENT. THE SURGEON ASKED FOR THE CLIP APPLIER AND THE TECH FIRED THE DEVICE TO PRELOAD A CLIP. THE SURGEON FIRED THE DEVICE ON AN ARTERY BRANCHING FROM THE VENA CAVA AND NO CLIP WAS IN THE JAWS THEN THE ARTERY BECAME CUT IN HALF. A VASCULAR SURGEON WAS CALLED IN TO REPAIR THE CUT ARTERY. THE SURGEON CONTROLLED THE BLEEDING WITH HIS FINGER BY APPLYING PRESSURE UNTIL THE VASCULAR SURGEON ARRIVED TO REPAIR THE ARTERY.

    Description of Event or Problem · 1

    THE FACILITY REPORTED A COLLEAGUE PUMP WITH FAILURE CODE 810:11. IT WAS NOT SPECIFIED WHEN REPORTED CONDITION OCCURRED. THERE WAS NO DOCUMENTED PATIENT INJURY OR MEDICAL INTERVENTION NECESSARY. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS DEVICE UTILIZES USER INTERFACE MODULE MASTER SOFTWARE VERSION 5.09.90 CATEGORIZED AS REMEDIATED. DURING REVIEW OF THE EVENT HISTORY IT WAS DETERMINED THAT THE REPORTED CONDITION OCCURRED DURING DELIVERY CAUSING AN INTERRUPTION OF DELIVERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGACLIP*MCA CLIP, IMPLANTABLE GDO ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1