BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHOTIP ULTRA ENDOSCOPIC ULTRASOUND NEEDLE

    MDR report key: 3669763 · Received November 29, 2013

    Report

    Report Number
    3001845648-2013-00136
    Event Type
    Malfunction
    Date Received
    November 29, 2013
    Date of Event
    October 31, 2013
    Report Date
    November 1, 2013
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FCG
    PMA / PMN Number
    K934356
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    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-HD-19-C. THE REPORTING PRECEDENCE COVERS THE ENTIRE PRODUCT FAMILY. THEREFORE, ALL ECHO DEVICES INVOLVING A PROXIMAL NEEDLE BREAKAGE AND OR THE NON RETRACTION OF THE NEEDLE ARE REPORTABLE REGARDLESS OF PATIENT OUTCOME. THE COMPLAINT INFORMATION PROVIDED WAS AS FOLLOWS: "THE NEEDLE WAS ADVANCED INTO THE MASS. THE PHYSICIAN HEARD A SNAP AND NEEDLE WAS NO LONGER ENGAGED. WHEN THE PHYSICIAN TRIED TO GET SPECIMEN OUT OF NEEDLE, IT WAS NOTICED THERE WAS LEAKING FROM WHERE THE CATHETER IS ATTACHED TO THE HANDLE. THE PHYSICIAN USED ANOTHER NEEDLE TO COMPLETE THE PROCEDURE. NO HARM TO THE PATIENT." THERE WERE NO ECHO-25 (ECHO) DEVICES OF LOT NUMBER C926026 IN STOCK AT THE TIME OF THE COMPLAINT INVESTIGATION. THE ECHO DEVICE INVOLVED IN THIS COMPLAINT WAS NOT RETURNED FOR EVALUATION. THEREFORE, THE CUSTOMERS' COMPLAINT CANNOT BE CONFIRMED. WITH THE INFORMATION PROVIDED, A DOCUMENT BASED INVESTIGATION WAS CARRIED OUT. FROM THE COMPLAINT DESCRIPTION PROVIDED, IT IS POSSIBLE TO ASSUME THE REPORTED FAILURE IS A NEEDLE BREAKAGE OCCURRING BELOW THE SHEATH EXTENDER. THE MOST LIKELY CAUSE OF THIS NEEDLE BREAKAGE MAY BE ATTRIBUTED TO THE NEEDLE KINKING DISTAL TO THE SHEATH EXTENDER. THIS KINK MOST LIKELY OCCURRED DUE TO PRODUCT HANDLING WHEN REMOVING THE DEVICE FROM THE PACKAGING OR DUE TO PRODUCT HANDLING WHEN THE DEVICE IS ATTACHED TO THE ENDOSCOPE. IF THE HANDLE OF THE ECHO DEVICE IS NOT APPROPRIATELY HANDLED, IT IS POSSIBLE FOR THE SHEATH/NEEDLE TO BECOME KINKED. HOWEVER, AS THE ECHO DEVICE INVOLVED IN THIS COMPLAINT WAS NOT RETURNED FOR EVALUATION, IT IS NOT POSSIBLE TO CONCLUSIVELY STATE THE ROOT CAUSE OF THIS COMPLAINT. THE COMPLAINT INFORMATION RECEIVED CONFIRMED NO PART OF THE NEEDLE DETACHED INSIDE OF THE PATIENT. NO ADVERSE EFFECTS TO THE PATIENT WERE REPORTED AS A RESULT OF THIS OCCURRENCE. THE COMPLAINT INFORMATION RECEIVED CONFIRMED ANOTHER DEVICE WAS USED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. PRIOR TO DISTRIBUTION, ALL ECHO DEVICES ARE SUBJECTED TO FUNCTIONAL CHECKS AND VISUAL INSPECTION TO ENSURE DEVICE INTEGRITY. THIS INCLUDES A VISUAL INSPECTION OF THE PRODUCT FOR KINKS. A REVIEW OF THE RELEVANT MANUFACTURING RECORDS FOR THIS ECHO DEVICE DID NOT REVEAL ANY DISCREPANCIES WHICH COULD HAVE CONTRIBUTED TO THE COMPLAINT ISSUE. NO CORRECTIVE ACTION IS WARRANTED AT THIS TIME. THIS EVENT DID NOT IMPACT THE PATIENT OR USER. THE 2 YEAR COMPLAINT HISTORY HAS BEEN REVIEWED FOR THIS RPN AND THE LIKELIHOOD OF THIS TYPE OF OCCURRENCE IS LOW. 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. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 1

    THE NEEDLE WAS ADVANCED INTO THE MASS. THE PHYSICIAN HARD A SNAP AND NEEDLE WAS NO LONGER ENGAGED. WHEN THE PHYSICIAN TRIED TO GET SPECIMEN OUT OF NEEDLE, IT WAS NOTICED THERE WAS LEAKING FROM WHERE THE CATHETER IS ATTACHED TO THE HANDLE. THE PHYSICIAN USED ANOTHER NEEDLE TO COMPLETE THE PROCEDURE. NO HARM TO THE PATIENT. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT'S BODY. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    621754 ECHOTIP ULTRA ENDOSCOPIC ULTRASOUND NEEDLE FCG KIT, NEEDLE, BIOPSY FCG COOK IRELAND LTD C926026

    Patients

    Seq Age Sex Outcome Treatment
    1