BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHOTIP ULTRA ENDOSCOPIC ULTRASOUND NEEDLE

    MDR report key: 4030409 · Received July 29, 2014

    Report

    Report Number
    3001845648-2014-00142
    Event Type
    Malfunction
    Date Received
    July 29, 2014
    Date of Event
    June 16, 2014
    Report Date
    July 4, 2014
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FCG
    PMA / PMN Number
    K083330
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L PMA/510(K) #: K934356. THIS EVENT WAS DEEMED FDA MDR REPORTABLE BASED ON THE REPORTING PRECEDENCE ESTABLISHED FOR THIS PRODUCT FAMILY FOR "PROXIMAL NEEDLE BREAKAGE" REGARDLESS OF PATIENT OUTCOME. THERE WERE NO ECHO-19 DEVICES OF LOT# C942764 IN STOCK AT THE TIME OF THE COMPLAINT INVESTIGATION. 1 X ECHO-19 DEVICE OF LOT# C942764 WAS RETURNED FOR EVALUATION. THE DEVICE WAS NOT RETURNED IN ITS ORIGINAL PACKAGING HOWEVER THE ORIGINAL LABEL WAS ATTACHED CONFIRMING THE LOT NUMBER. THIS ECHO DEVICE WAS RETURNED WITH THE STYLET FULLY INSERTED IN THE DEVICE AND THE NEEDLE ADVANCED TO REFERENCE MARK 7-8 FOR NEEDLE ADVANCEMENT; HOWEVER NO PART OF THE NEEDLE WAS OUTSIDE THE SHEATH. THE SHEATH WAS SET AT REFERENCE MARK 2.5-3 ON RECEIPT. THE SHEATH HAD SEPARATED FROM THE DEVICE AND NO SHEATH WAS PRESENT ON THE NEEDLE FOR APPROX 7CM BELOW THE SHEATH EXTENDER. THE STYLET WAS REMOVED FROM THE DEVICE AND IT WAS CONFIRMED THAT THE NEEDLE WAS BROKEN AND WAS HELD TOGETHER BY THE STYLET. THE NEEDLE HAD SEPARATED APPROX 10CM BELOW THE SHEATH EXTENDER WHEN THE NEEDLE WAS FULLY ADVANCED AND THE SHEATH EXTENDER WAS POSITIONED AT REFERENCE MARK 5. THE HANDLE WAS DISMANTLED AND THE NEEDLE WAS REMOVED. IT MEASURED APPROX. 30CM IN LENGTH FROM THE BASE OF THE PROXIMAL LUER LOCK, CORRESPONDING WITH THE END OF THE SHEATH EXTENDER. THE PART OF THE NEEDLE AND SHEATH THAT SEPARATED FROM THE HANDLE WAS MEASURED AND NOTED TO BE APPROX. 140CM IN LENGTH. THE NEEDLE WAS NOT VISIBLE OUTSIDE THE SHEATH. THE TIP OF THE SHEATH WAS REMOVED AND THE NEEDLE TIP WAS EXPOSED. THE NEEDLE TIP WAS EXAMINED UNDER THE MICROSCOPE AND NO DAMAGED WAS NOTED. NO PART OF THE DEVICE WAS CONFIRMED TO BE MISSING. THE CUSTOMER COMPLAINT WAS CONFIRMED AS THE PROXIMAL END OF THE NEEDLE WAS BROKEN BELOW THE SHEATH EXTENDER. THE MOST LIKELY CAUSE OF THIS NEEDLE BREAKAGE MAY BE ATTRIBUTED TO THE NEEDLE KINKING BELOW THE SHEATH EXTENDER WHICH LED TO THE BREAKAGE. THE KINKING BELOW THE 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 BENT/KINKED DUE TO THE WEIGHT OF THE HANDLE. AS THE NEEDLE WAS ADVANCED/RETRACTED DURING THE PROCEDURE IT IS POSSIBLE THIS KINK WOULD RESULT IN A BREAKAGE. THE COMPLAINT INFORMATION REPORTED THAT NEEDLE PUNCTURE INTO THE TARGET SITE WAS NOT POSSIBLE DUE TO HIGH RESISTANCE. THIS MAY ALSO HAVE CONTRIBUTED TO NEEDLE BREAKAGE. AS THE CONDITIONS OF USE CANNOT BE REPLICATED DURING THE LABORATORY EVALUATION IT IS NOT POSSIBLE TO CONCLUSIVELY DETERMINE THE ROOT CAUSE OF THIS COMPLAINT. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED OF THIS COMPLAINT EVENT. PRIOR TO DISTRIBUTION, ALL ECHO-19 DEVICES ARE SUBJECTED TO FUNCTIONAL CHECKS AND VISUAL INSPECTION TO ENSURE DEVICE INTEGRITY. A REVIEW OF THE MANUFACTURING RECORDS FOR ECHO-19 LOT# C942764 REVEALED NO ISSUES WHICH COULD HAVE CONTRIBUTED TO THIS COMPLAINT REPORT. THE NOTES SECTION OF THE INSTRUCTIONS FOR USE IFU0101-0 INSTRUCTS THE USER PRIOR TO USE 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." THE PATIENT DID NOT EXPERIENCE ANY KNOWN ADVERSE EFFECTS DUE TO THIS OCCURRENCE. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 1

    THE NEEDLE CATHETER WAS INTRODUCED INTO THE ENDOSCOPE. PUNCTURE WAS NOT POSSIBLE DUE TO HIGH RESISTANCE. THE NEEDLE WAS REMOVED AND A KINK WAS NOTICED (APPROXIMATELY 10 CM FROM HANDLE) AND PLASTIC CATHETER MATERIAL WASN'T ADAPTED (TO THE HANDLE SIDE) ANYMORE. THE DEVICE WAS EVALUATED ON THE (B)(4) 2014 AND IT WAS CONFIRMED THE NEEDLE WAS BROKEN PROXIMALLY. NO INFORMATION RECEIVED PRIOR TO THE EVALUATION INDICATING A NEEDLE BREAKAGE. NO ADVERSE EFFECTS TO THE PATIENT HAVE BEEN REPORTED AS OCCURRING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    441814 ECHOTIP ULTRA ENDOSCOPIC ULTRASOUND NEEDLE FCG KIT, NEEDLE, BIOPSY FCG COOK IRELAND LTD C942764

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK