BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHOTIP ULTRA ENDOSCOPIC ULTRASOUND NEEDLE

    MDR report key: 3853242 · Received April 4, 2014

    Report

    Report Number
    3001845648-2014-00061
    Event Type
    Malfunction
    Date Received
    April 4, 2014
    Date of Event
    March 7, 2014
    Report Date
    March 7, 2014
    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

    THIS COMPLAINT REPORT MEETS THE REPORTING CRITERIA IF AN FDA MDR REPORT BASED ON THE REPORTING PRECEDENCE ESTABLISHED FOR PROXIMAL NEEDLE BREAKAGES AND THE NON-RETRACTION OF THE NEEDLE; REGARDLESS OF PT OUTCOME. THERE WERE NO ECHO-19 (ECHO) DEVICES OF LOT # C922252 IN STOCK AT THE TIME OF THE COMPLAINT INVESTIGATION. 1 X ECHO DEVICE OF LOT # C922252, WAS RETURNED FOR EVALUATION. THE DEVICE WAS RETURNED IN THE ORIGINAL PACKAGE AND WAS OPENED ON RECEIPT. THE STYLET WAS IN PLACE ON EVALUATION OF THE RETURNED DEVICE. A KINK WAS NOTED IN THE SHEATH ABOUT 3.5 CM BELOW THE SHEATH EXTENDER. THE NEEDLE WAS NOTED TO BE 0.8 CM PROTRUDING FROM THE SHEATH. THE STYLET WAS REMOVED FROM THE NEEDLE AND THE DISTAL NEEDLE TIP WAS EXAMINED UNDER THE MICROSCOPE AND WAS CONFIRMED TO BE INTACT. THE NEEDLE TIP WAS NOTED TO BE BENT. THE CUSTOMER COMPLAINT WAS CONFIRMED AS THE ECHO DEVICE WAS RETURNED WITH THE NEEDLE BROKEN APPROX. 138 CM FROM THE DISTAL TIP. THE BREAKAGE WAS NOTED TO BE A CLEAN OBLONG BREAK BELOW THE SHEATH EXTENDER. THE MOST LIKELY CAUSE OF THIS NEEDLE BREAKAGE MAY BE ATTRIBUTED TO THE NEEDLE KINKING BELOW THE SHEATH EXTENDER. THIS KINKING 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 RELEVANT PERSONNEL HAVE BEEN NOTIFIED OF THIS COMPLAINT EVENT. PRIOR TO DISTRIBUTION, ALL ECHO DEVICES ARE SUBJECTED TO FUNCTIONAL CHECKS AND VISUAL INSPECTION TO ENSURE DEVICE INTEGRITY. A REVIEW OF THE MFG RECORDS DID NOT REVEAL A DISCREPANCY WHICH WOULD HAVE CONTRIBUTED TO THE COMPLAINT ISSUE. IT WAS CONFIRMED THAT THE PT DID NOT EXPERIENCED ANY 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 DEVICE WAS USED FOR EUS-FNA. THE NEEDLE WAS ADVANCED INTO THE PANCREAS SMOOTHLY AT THE FIRST ATTEMPT. THE ANGLE OF THE ENDOSCOPE WAS NOT AS TIGHT AS IT COULD APPLY FORCIBLE TENSION TO THE DEVICE. HOWEVER, AT THE SECOND ATTEMPT, THE NEEDLE COULD NOT BE RETRACTED INTO THE SHEATH AFTER ADVANCING INTO THE TARGET SITE. THE DEVICE WAS REMOVED FROM THE ENDOSCOPE WITH THE NEEDLE ADVANCED OUT FROM THE SHEATH AND ANOTHER NEW DEVICE WAS USED INSTEAD. THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PT REPORTED AS OCCURRING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    205224 ECHOTIP ULTRA ENDOSCOPIC ULTRASOUND NEEDLE FCG KIT, NEEDLE, BIOPSY FCG COOK IRELAND LTD C922252

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK