BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECHOTIP ULTRA HIGH DEFINITION ULTRASOUND ACCESS NEEDLE

    MDR report key: 5995922 · Received October 4, 2016

    Report

    Report Number
    3001845648-2016-00278
    Event Type
    Injury
    Date Received
    October 4, 2016
    Date of Event
    August 31, 2016
    Report Date
    September 8, 2016
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FCG
    UDI-DI
    00827002520127
    PMA / PMN Number
    K092359
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON EVALUATION OF THE RETURNED DEVICE, THE SHEATH OF THE DEVICE WAS EXAMINED AND NO KINKS WERE NOTED BELOW THE SHEATH EXTENDER WHEN THE SHEATH EXTENDER WAS POSITIONED AT REFERENCE MARK 3 AND THE NEEDLE EXTENDER AT REFERENCE MARK 0. THE DEVICE WAS RETURNED WITH 30MM OF THE STYLET NOT INSERTED AND THE NEEDLE OF THE DEVICE FULLY RETRACTED. THE STYLET WAS REMOVED AND NO DAMAGE WAS EVIDENT ON THE COMPONENT. THE NEEDLE OF THE DEVICE WAS RETURNED WITH 2.6CM OF THE DISTAL END OF THE NEEDLE BROKEN OFF, THIS WAS RETURNED WITH THE DEVICE IN A SEPARATE CONTAINER. A KINK ON THE SHEATH WAS NOTED 3CM FROM THE DISTAL END. IT WAS NOTED BY THE RESEARCH & DEVELOPMENT ENGINEER THAT THE KINK IS MOST LIKELY SECONDARY AND NOT THE CAUSE OF THE ISSUE. DAMAGE WAS ALSO OBSERVED AT THE END OF THE SHEATH AND WAS IT STATED BY THE RESEARCH & DEVELOPMENT ENGINEER THAT IT IS POSSIBLE THAT THIS OCCURRED WHEN THE NEEDLE BROKE. THE CUSTOMER COMPLAINT WAS CONFIRMED AS THE NEEDLE WAS BROKEN. AS THE CONDITIONS OF USE CANNOT BE REPLICATED DURING THE LABORATORY EVALUATION, IT IS NOT POSSIBLE TO CONCLUSIVELY DETERMINE THE ROOT CAUSE FOR THE NEEDLE BREAKAGE. PRIOR TO DISTRIBUTION, ALL ECHO-HD-19-A DEVICES ARE SUBJECTED TO FUNCTIONAL CHECKS AND VISUAL INSPECTION TO ENSURE DEVICE INTEGRITY. THESE INSPECTIONS AND FUNCTIONAL CHECKS ARE OUTLINED IN INTERNAL PROCEDURES IN PLACE AT CIRL. A REVIEW OF THE MANUFACTURING RECORDS FOR ECHO-HD-19-A DEVICE OF LOT# C1194790 DID NOT REVEAL ANY DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT ISSUE. THE PATIENT DID NOT EXPERIENCE 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

    IT WAS REPORTED THAT THE DOCTOR TRIED TO PRICK INTO THE CYST, THE NEEDLE BENT AND BROKE. THE BROKEN PIECE WAS RECOVERED. A NEW NEEDLE WAS USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    648485 ECHOTIP ULTRA HIGH DEFINITION ULTRASOUND ACCESS NEEDLE FCG KIT, NEEDLE, BIOPSY FCG COOK IRELAND LTD 00827002520127

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention