BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHOTIP PROCORE HIGH DEFINITION ULTRASOUND BIOPSY NEEDLE

    MDR report key: 3102143 · Received May 3, 2013

    Report

    Report Number
    3001845648-2013-00038
    Event Type
    Malfunction
    Date Received
    May 3, 2013
    Date of Event
    April 8, 2013
    Report Date
    April 8, 2013
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FCG
    PMA / PMN Number
    K083330
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFO PROVIDED INDICATED THE DEVICE INVOLVED IN THIS COMPLAINT TO BE AN ECHO-HD-19-C (ECHO) DEVICE. THE LOT NUMBER WAS NOT PROVIDED, THEREFORE IT WAS NOT POSSIBLE TO CHECK IF ANY OF THE AFFECTED LOT REMAINED IN STOCK. INFO RECEIVED CONFIRMED THE ECHO DEVICE INVOLVED IN THIS COMPLAINT WAS UNAVAILABLE FOR RETURN. FURTHER CLARIFICATION WAS RECEIVED ON THE LOCATION OF THE NEEDLE BREAKAGE AS FOLLOWS: "IT IS NOT POSSIBLE TO CONFIRM ACCURATE LOCATION THROUGH, THE PHYSICIAN ASSUMES THAT IT WAS BROKEN AND BECAME SEPARATED FROM THE NEEDLE HUB, THE JOINT PART BETWEEN NEEDLE AND HANDLE. (SHEATH WAS STILL ATTACHED TO THE HANDLE BUT ONLY THE NEEDLE INSIDE THE SHEATH BECAME SEPARATED.)" CONFIRMATION REGARDING THE LOCATION OF THE NEEDLE BREAKAGE OR WHAT PART OF THE NEEDLE DETACHED INSIDE THE SCOPE WAS NOT RECEIVED. INFO RECEIVED CONFIRMED NO SECTION OF THE NEEDLE REMAINED IN THE PT, THE PIECE OF NEEDLE THAT BROKE DETACHED INSIDE THE SCOPE WHICH WAS SUCCESSFULLY RETRIEVED. THE ECHO DEVICE INVOLVED IN THIS COMPLAINT WAS NOT RETURNED FOR EVAL. THEREFORE, THE CUSTOMER'S COMPLAINT REMAINS UNCONFIRMED. WITH THE INFO PROVIDED A DOCUMENT BASED INVESTIGATION WAS CARRIED OUT. THE RELEVANT PERSONNEL WERE CONTACTED IN RELATION TO THIS COMPLAINT AND DETERMINED THAT A BREAKAGE WITHIN THE HANDLE WOULD BE VERY UNLIKELY FOR A 19GA NEEDLE AND IT IS MORE LIKELY THAT THIS FAILURE OCCURRED BELOW THE SHEATH EXTENDER. IF THE NEEDLE BROKE BELOW THE SHEATH EXTENDER A POSSIBLE CAUSE OF THIS BREAKAGE MAY BE ATTRIBUTED TO THE NEEDLE BECOMING KINKED AT THIS POINT. AS THE USER ADVANCES AND RETRACTS THE NEEDLE THIS KINK MAY HAVE RESULTED IN A NEEDLE BREAKAGE. THIS KINK MAY HAVE OCCURRED DUE TO PRODUCT HANDLING WHEN REMOVING THE DEVICE FROM THE PACKAGING OR DURING DEVICE INTRODUCTION INTO THE ENDOSCOPE. IF THE HANDLE OF THE ECHO DEVICE IS NOT APPROPRIATELY HANDLED IT IS POSSIBLE FOR THE SHEATH TO BECOME KINKED DUE TO THE WEIGHT OF THE HANDLE. HOWEVER AS INFO REGARDING THE LOCATION OF THE NEEDLE BREAKAGE WAS NOT RECEIVED AND THE ECHO DEVICE INVOLVED WAS NOT RETURNED FOR EVAL IT IS NOT POSSIBLE TO STATE A CAUSE FOR THIS COMPLAINT. PRIOR TO DISTRIBUTION, ALL ECHO DEVICES ARE SUBJECTED TO FUNCTIONAL CHECKS AND VISUAL INSPECTION TO ENSURE DEVICE INTEGRITY. NO CORRECTIVE ACTION IS WARRANTED AT THIS TIME. INFO RECEIVED CONFIRMED NO SECTION OF THE NEEDLE REMAINED IN THE PT, THE PIECE OF NEEDLE THAT BROKE DETACHED INSIDE THE SCOPE WHICH WAS SUCCESSFULLY RETRIEVED. THE 2 YEAR COMPLAINT HISTORY HAS BEEN REVIEWED FOR THIS RPN AND THE LIKELIHOOD OF THIS TYPE OF OCCURRENCE IS LOW. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 1

    INITIAL COMPLAINT INFO RECEIVED AS FOLLOWS: "AT THE THIRD ATTEMPT OF BIOPSY, THE PHYSICIAN FELT RESISTANCE WHEN MANIPULATING THE HANDLE TO ADVANCE THE NEEDLE INTO THE LESION. HE ONCE STOPPED THE THIRD ATTEMPT AND REMOVED THE DEVICE FROM THE PT BODY, THEN IT WAS CONFIRMED THAT THE DEVICE COULD BE MANIPULATED WITH NO PROBLEM. THE DEVICE WAS REINSERTED INTO THE ENDOSCOPE, BUT RESISTANCE SUCH AS THE DEVICE WAS CAUGHT ON THE ENDOSCOPE CHANNEL WAS ENCOUNTERED DURING INSERTION. THE PHYSICIAN TRIED TO REMOVE THE DEVICE FROM THE ENDOSCOPE AGAIN, BUT THE NEEDLE WAS BROKEN DURING REMOVAL AND ONLY THE BROKEN NEEDLE REMAINED IN THE CHANNEL. THE REMAINED SECTION OF THE NEEDLE WAS TAKEN FROM THE CHANNEL AND THE PHYSICIAN NOTICED THAT THE ENDOSCOPE CHANNEL WAS DAMAGED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194736 ECHOTIP PROCORE HIGH DEFINITION ULTRASOUND BIOPSY NEEDLE FCG KIT, NEEDLE, BIOPSY FCG COOK IRELAND LTD UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK