BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHOTIP ULTRA ENDOBRONCHIAL ULTRASOUND NEEDLE

    MDR report key: 3554036 · Received December 19, 2013

    Report

    Report Number
    3001845648-2013-00145
    Event Type
    Malfunction
    Date Received
    December 19, 2013
    Date of Event
    November 27, 2013
    Report Date
    November 27, 2013
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FCG
    PMA / PMN Number
    K093195
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS REPORTABLE TO THE FDA ON THE BASIS OF A PREVIOUS ADVERSE EVENT FOR AN ECHO-19 WHERE THE DISTAL TIP OF THE NEEDLE BROKE AND A SECTION OF THE NEEDLE DETACHED IN THE PATIENT REQUIRING REMOVAL. THE REPORTING PRECEDENCE COVERS THE ENTIRE PRODUCT FAMILY. THEREFORE, ALL ECHO DEVICES INVOLVING DISTAL TIP NEEDLE BREAKAGES ARE REPORTABLE REGARDLESS OF PATIENT OUTCOME.

    Description of Event or Problem · 1

    THE TIP OF THE NEEDLE HAS BROKEN. ADDITIONAL COMPLAINT INFORMATION RECEIVED INDICATED IT WAS MOST LIKELY THE TIP BROKE DURING THE SAMPLE MANIPULATION OUTSIDE THE PATIENT. THE BROKEN DISTAL TIP OF THE NEEDLE WAS NOT RETURNED FOR EVALUATION. THE LOCATION OF THE BROKEN NEEDLE PIECE COULD NOT BE CONFIRMED BY THE USER. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. THE CUSTOMER'S COMPLAINT ISSUE WAS REPORTED AS FOLLOWS: THE TIP OF THE NEEDLE HAS BROKEN. THERE WERE NO ECHO-HD-22-EBUS-P (ECHO) DEVICES OF LOT #C912718 IN STOCK AT THE TIME OF THE COMPLAINT INVESTIGATION. 1 X ECHO DEVICE OF LOT #C912718 WAS RETURNED FOR EVALUATION. THE DEVICE WAS RETURNED IN THE ORIGINAL PACKAGING AND WAS OPEN ON RECEIPT. THE ECHO DEVICE WAS RECEIVED WITH THE NEEDLE FULLY RETRACTED. THE STYLET WAS NOT RETURNED WITH THE DEVICE. UPON EVALUATION OF THIS ECHO DEVICE IT WAS POSSIBLE TO ADVANCE/RETRACT THE NEEDLE FREELY. THE NEEDLE EXTENSION WAS EXAMINED AND CONFIRMED TO BE BROKEN AT THE DISTAL END. THE BROKEN DISTAL NEEDLE TIP WAS NOT RETURNED FOR EVALUATION. THE SHEATH WAS EXAMINED AND NO DAMAGE WAS NOTED ALONG THE SHEATH OR AT THE SHEATH TIP. THE NEEDLE WAS EXAMINED UNDER THE MICROSCOPE AND IT WAS CONFIRMED THAT THE TIP SEPARATED AT THE DIMPLED SECTION OF THE NEEDLE. WHEN THE NEEDLE WAS FULLY ADVANCED IT MEASURED APPROX 3.5CM, CONFIRMING THAT APPROX. 1.5CM OF THE NEEDLE TIP IS MISSING. NO ISSUE WERE NOTED FROM THE LABORATORY ANALYSIS THAT COULD HAVE CONTRIBUTED TO THIS NEEDLE BREAKAGE. ON EVALUATION OF THE RETURNED DEVICE THE CUSTOMER COMPLAINT WAS CONFIRMED AS THE DISTAL NEEDLE TIP WAS CONFIRMED TO BE BROKEN AND WAS NOT RETURNED. THE BROKEN PART OF THE NEEDLE WAS CONFIRMED TO BE MISSING. IT WAS INDICATED THAT THE TIP MOST LIKELY BROKE DURING THE SAMPLE MANIPULATION OUTSIDE THE PATIENT; HOWEVER THIS COULD NOT BE CONFIRMED BY THE USER. THE MOST PROBABLY CAUSE OF THIS DISTAL TIP NEEDLE BREAKAGE CAN BE ATTRIBUTED TO A KINK/BEND OF THE DISTAL TIP. A CAUSE FOR THE NEEDLE TIP BECOMING KINKED/BENT AND SUBSEQUENTLY BROKEN MAY BE ATTRIBUTED TO INDIVIDUAL PATIENT ANATOMY IF THE AREA BEING SAMPLED WAS A PARTICULARLY HARD MASS OR LESION. INFORMATION CONCERNING THE SPECIFIC LYMPH NODE BEING SAMPLED DURING THIS PROCEDURE WAS NOT RECEIVED. IT IS ALSO POSSIBLE THE DISTAL NEEDLE TIP WAS DAMAGED DUE TO PRODUCT HANDLING WHEN ADVANCING/REMOVING THE DEVICE FROM THE ENDOSCOPE OR DURING SAMPLE RETRIEVAL. AS THE CONDITIONS OF DEVICE USAGE CANNOT BE REPLICATED DURING THE DEVICE EVALUATION IT IS NOT POSSIBLE TO CONCLUSIVELY STATE THE ROOT CAUSE OF THIS COMPLAINT. PRIOR TO DISTRIBUTION, ALL ECHO DEVICES ARE SUBJECTED TO FUNCTIONAL CHECKS AND VISUAL INSPECTION TO ENSURE INTEGRITY OF THE PRODUCT. A REVIEW OF THE RELEVANT MANUFACTURING RECORDS DID NOT REVEAL A DISCREPANCY WHICH COULD HAVE CONTRIBUTED TO THIS DISTAL TIP NEEDLE BREAKAGE/BEND. NO CORRECTIVE ACTION IS WARRANTED AT THIS TIME. NO ADVERSE EFFECTS TO THE PATIENT WERE REPORTED AS A RESULT OF THIS OCCURRENCE. A HEALTH RISK ASSESSMENT WAS CARRIED OUT TO ASSESS THE RISK OF NEEDLE BREAKAGE ACROSS THE ECHO PRODUCT FAMILY AND WAS DETERMINED TO BE LOW RISK. A HEALTH RISK ASSESSMENT SPECIFIC TO NEEDLE BREAKAGE ACROSS THE EBUS PRODUCT FAMILY HAS BEEN GENERATED AND HAS BEEN DETERMINED TO BE LOW RISK. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    666503 ECHOTIP ULTRA ENDOBRONCHIAL ULTRASOUND NEEDLE FCG KIT, NEEDLE, BIOPSY FCG COOK IRELAND LTD C912718

    Patients

    Seq Age Sex Outcome Treatment
    1 REQUEST