BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHOTIP ULTRA ENDOSCOPIC ULTRASOUND NEEDLE

    MDR report key: 3905096 · Received May 23, 2014

    Report

    Report Number
    3001845648-2014-00087
    Event Type
    Malfunction
    Date Received
    May 23, 2014
    Date of Event
    November 18, 2013
    Report Date
    April 25, 2014
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FCG
    PMA / PMN Number
    K083330
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THIS COMPLAINT WAS RETURNED FOR EVALUATION ON 04/25/2014. THE DEVICE WAS EVALUATED ON 04/25/2014. DURING THE EVALUATION, THE NEEDLE WAS CONFIRMED TO BE BROKEN. THIS COMPLAINT REPORT MEETS THE REPORTING CRITERIA OF AN FDA MDR REPORT BASED ON THE REPORTING PRECEDENCE FOR DISTAL NEEDLE BREAKAGES FOR THIS PRODUCT FAMILY, REGARDLESS OF PATIENT OUTCOME. THERE WERE NO ECHO-25 DEVICES OF LOT NUMBER C883886 IN STOCK AT THE TIME OF THE INVESTIGATION. ONE ECHO-25 DEVICE OF LOT NUMBER C883886 WAS RETURNED FOR EVALUATION. THE DEVICE WAS RETURNED IN THE ORIGINAL PACKAGE AND WAS OPEN ON RECEIPT. THIS ECHO DEVICE WAS RECEIVED WITH THE STYLET FULLY REMOVED FROM THE DEVICE. THE NEEDLE OF THE DEVICE WAS ADVANCED APPROX. 2.5 CM ON RECEIPT. ON EVALUATION OF THE DEVICE THE NEEDLE COULD NOT BE FULLY ADVANCED, NEEDLE ADVANCES APPROX 2.5 CM. IT WAS NOT POSSIBLE TO RETRACT THE NEEDLE INTO THE SHEATH. THE SHEATH WAS EXAMINED AND A SEVERE KINK WAS NOTED BELOW THE SHEATH EXTENDER, WHEN THE SHEATH EXTENDER WAS POSITIONED AT REFERENCE MARK 5. THE DISTAL NEEDLE TIP WAS EXAMINED AND CONFIRMED TO BE INTACT. THE STYLET COULD NOT BE ADVANCED INTO THE DEVICE. TO FURTHER INVESTIGATE THE NEEDLE NOT FULLY ADVANCING, THE OUTER HANDLE WAS DISMANTLED AND THE NEEDLE WAS REMOVED FROM THE DEVICE. THE NEEDLE WAS NOTED TO BE BROKEN AT THE BASE OF THE HANDLE, APPROX. 20CM BELOW THE PROXIMAL LEUR LOCK. THIS COINCIDES WITH THE DISTAL END OF THE HANDLE. THE CUSTOMER COMPLAINT WAS CONFIRMED AS THE NEEDLE OF THE DEVICE WAS BROKEN IN THE DISTAL END OF THE HANDLE RESULTING IN DIFFICULTY ADVANCING/RETRACTING THE NEEDLE. IT WAS DETERMINED DURING THE DEVICE EVALUATION THAT THE CAUSE OF THE NEEDLE BREAKING AT THE DISTAL END OF THE HANDLE MAY BE ATTRIBUTED TO THE NEEDLE KINKING AT THIS POINT. AS THE NEEDLE WAS ADVANCED/RETRACTED DURING THE PROCEDURE THE KINK WOULD HAVE RESULTED IN A NEEDLE BREAKAGE AND THE CUSTOMER'S DIFFICULTY WITH NEEDLE ADVANCEMENT / RETRACTION. DUE TO A VARIETY OF CLINICAL CONDITIONS SUCH AS PATIENT ANATOMY, ENDOSCOPE POSITION OR PROGRESSION OF DISEASE STATE, WE COULD NOT REPRODUCE THE ACTUAL CONDITIONS OF DEVICE USAGE DURING OUR LABORATORY EVALUATION. AS THE CONDITIONS OF DEVICE USAGE COULD NOT BE REPLICATED WE WERE UNABLE TO DETERMINE A CAUSE FOR THE NEEDLE KINKING IN THE HANDLE. IT WAS DETERMINED THAT THE KINK TO THE SHEATH/NEEDLE BELOW THE SHEATH EXTENDER MOST LIKELY OCCURRED DUE TO PRODUCT HANDLING WHEN REMOVING THE DEVICE FROM THE PACKAGING OR HANDLING OF THE DEVICE WHILE ATTACHED TO 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. FROM THE INFORMATION PROVIDED, GAINING ACCESS AND NEEDLE PENETRATION TO THE TARGETED SITE WAS DIFFICULT AND THE SCOPE WAS IN A FLEXED POSITION DURING THE PROCEDURE. THESE CONDITIONS MAY ALSO HAVE CONTRIBUTED TO THE NEEDLE BREAKAGE. PRIOR TO DISTRIBUTION, ALL ECHO DEVICES ARE SUBJECTED TO FUNCTIONAL CHECKS AND VISUAL INSPECTION TO ENSURE DEVICE INTEGRITY. A REVIEW OF THE RELEVANT MANUFACTURING RECORDS FOR THIS ECHO DEVICE OF LOT NUMBER C883886 DID NOT REVEAL ANY DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. THE NOTES SECTION OF THE INSTRUCTIONS FOR USE IFU0101-0 INSTRUCTS THE USER TO "VISUALLY INSPECT WITH PARTICULAR ATTENTION TO KINKS, BENDS AND BREAKS. IF AN ABNORMALITY IS DETECTED THAT WOULD PROHIBIT PROPER WORKING CONDITION, DO NOT USE." FROM THE INFORMATION PROVIDED THERE WERE NO ADVERSE EFFECTS TO THE PATIENT DUE TO THIS ISSUE. NO PART OF THE DEVICE REMAINED INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 1

    THE COMPLAINT INFORMATION REPORTED WAS AS FOLLOWS: "AT THE ENTRANCE WITH THE NEEDLE INTO THE LESION, THE HANDLE BECAME UNATTACHED." NO SECTION OF THE DEVICE REMAINED IN THE PATIENT OR HAD TO BE RETRIEVED. NO ADDITIONAL PROCEDURES WERE REQUIRED DUE TO THIS OCCURRENCE. NO ADVERSE EFFECTS ON THE PATIENT WERE REPORTED TO HAVE OCCURRED DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309135 ECHOTIP ULTRA ENDOSCOPIC ULTRASOUND NEEDLE FCG KIT, NEEDLE, BIOPSY FCG COOK IRELAND LTD C883886

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK