BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MCA LARGE APPLIER

    MDR report key: 2180109 · Received July 27, 2011

    Report

    Report Number
    3005075853-2011-03006
    Event Type
    Malfunction
    Date Received
    July 27, 2011
    Date of Event
    June 24, 2011
    Report Date
    June 30, 2011
    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
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). HOOP SPRING. THE ANALYSIS RESULTS FOUND THAT THE DEVICE WAS RECEIVED IN GOOD CONDITION. IN AN ATTEMPT TO REPLICATE THE REPORTED INCIDENT, THE DEVICE WAS TESTED FOR FUNCTIONALITY. UPON TESTING, THE TRIGGER COULD NOT BE COMPLETELY ACTIVATED DUE TO THE FIRING MECHANISM WAS JAMMED. IN ORDER TO EVALUATE THE CONDITION OF THE DEVICE'S INTERNAL COMPONENTS, THE DEVICE WAS DISASSEMBLED. UPON DISASSEMBLING, THE HOOP SPRING WAS FOUND OUT OF ITS INTENDED POSITION, JAMMING THE FIRING MECHANISM. NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE FOUND CONDITION OF THE HOOP SPRING. IT SHOULD BE NOTED THAT AS PART OF OUR QUALITY PROCESS, EACH DEVICE IS VISUALLY INSPECTED AND FUNCTIONALLY TESTED DURING MANUFACTURING TO ENSURE THE DEVICE MEETS THE REQUIRED SPECIFICATIONS PRIOR TO SHIPMENT. 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 PROSTATECTOMY PROCEDURE, THE CLIP WOULD NOT HOLD AFTER PLACING. FROM THE FIRST CLIP, (THE CLIPS WERE FULLY ADVANCED INTO THE JAWS PRIOR TO FIRING BACK THEN) THE CLIPS WOULDN'T HOLD AFTER PLACING (ILIAC VEIN). THERE WAS NO TORQUING OF THE DEVICE PRESENT AT THE TIME OF FIRING. AFTER THREE OF FOUR CLIPS, THE CLIPS WOULD NOT ADVANCE IN THE CLIP APPLIER. THE SURGEON HEARD AN UNUSUAL NOISE WHEN THE CLIP APPLIER STOOPED DELIVERING CLIPS. THE SURGEON FELT DIFFERENCE MANIPULATING THE DEVICE WHILE FIRING THE TRIGGER. THERE WERE NO MORE CLIPS ADVANCED INTO THE JAWS. THE DEVICE WAS NOT FIRED AFTER THIS INCIDENT. THE SURGEON USED ANOTHER LIKE DEVICE TO PERFORM THE PROCEDURE, WHICH ENDED WITHOUT FURTHER ISSUE. WHILE THE NURSE WAS LOOKING FOR A NEW CLIP APPLIER, THE CLIPS WERE NOT HOLDING AND THE PATIENT WAS BLEEDING A LITTLE, BUT HE DIDN'T NEED ANY TRANSFUSION. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MCA LARGE APPLIER CLIP, IMPLANTABLE GDO ETHICON ENDO-SURGERY, LLC. NA G4R725

    Patients

    Seq Age Sex Outcome Treatment
    1