BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHOTIP ULTRA ENDOBRONCHIAL HD ULTRASOUND NEEDLE

    MDR report key: 6453200 · Received April 3, 2017

    Report

    Report Number
    3001845648-2017-00109
    Event Type
    Malfunction
    Date Received
    April 3, 2017
    Date of Event
    March 3, 2017
    Report Date
    April 7, 2017
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FCG
    UDI-DI
    00827002534087
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    COOK IRELAND LTD (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI)(IMPORTER). EXEMPTION NUMBER: E2016031. INFORMATION PERTAINING TO SECTION G.1 AS FOLLOWS: IMPORTER SITE CONTACT AND ADDRESS: (B)(4) COOK MEDICAL INCORPORATED (CMI) 1025 ACUFF ROAD P.O BOX 4195 BLOOMINGTON INDIANA 47402-4195. IMPORTER SITE ESTABLISHMENT REGISTRATION NUMBER: 3005580113. PMA/510(K) # K160229. 1 X ECHO-HD-22-EBUS-P WAS RETURNED TO CIRL FOR EVALUATION. DURING THE LAB EVALUATION THE FOLLOWING WAS NOTED: THE STYLET WAS OUT OF THE DEVICE ON RETURN AND THE NEEDLE WAS FULLY RETRACTED. THE BROKEN PARK OF NEEDLE WAS RETURNED IN A TISSUE. THE SHEATH EXTENDER PART OF THE DEVICE WAS NOT RETURNED. THE BROKEN PART O THE NEEDLE MEASURE APPROXIMATELY 11MM (1.6CM). THE NEEDLE WAS REMOVED AND MEASURED APPROX. 94.7CM, THE BREAK WAS A DISTAL BREAK. THE CUSTOMER COMPLAINT IS CONSIDERED TO BE CONFIRMED DUE TO BROKEN NEEDLE. PRIOR TO DISTRIBUTION, ALL ECHO-HD-22-EBUS-P DEVICES ARE SUBJECTED TO FUNCTIONAL CHECKS AND VISUAL INSPECTION TO ENSURE INTEGRITY OF THE PRODUCT. THESE INSPECTIONS AND FUNCTIONAL CHECKS ARE OUTLINED IN INTERNAL PROCEDURES IN PLACE AT CIRL. A REVIEW OF THE MANUFACTURING RECORDS FOR ECHO DEVICES OF LOT# C1306641 DID NOT REVEAL ANY DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT ISSUE. FROM THE INFORMATION PROVIDED 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.

    Additional Manufacturer Narrative · 0

    COOK IRELAND LTD (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI)(IMPORTER). EXEMPTION NUMBER: E2016031. INFORMATION PERTAINING TO SECTION G. 1 AS FOLLOWS: IMPORTER SITE CONTACT AND ADDRESS: (B)(4) COOK MEDICAL INCORPORATED (CMI) 1025 ACUFF ROAD P.O BOX 4195 BLOOMINGTON INDIANA 47402-4195. IMPORTER SITE ESTABLISHMENT REGISTRATION NUMBER: 3005580113. PMA/510(K) # K160229. AS THE DEVICE WAS NOT RETURNED FOR EVALUATION; THE CAUSE OF THIS COMPLAINT COULD NOT BE CONCLUSIVELY DETERMINED. WITH THE INFORMATION PROVIDED A DOCUMENT BASED INVESTIGATION WAS CARRIED OUT. THE CUSTOMER COMPLAINT IS CONSIDERED TO BE CONFIRMED BASED ON CUSTOMER TESTIMONY. PRIOR TO DISTRIBUTION, ALL ECHO-HD-22-EBUS-P DEVICES ARE SUBJECTED TO FUNCTIONAL CHECKS AND VISUAL INSPECTION TO ENSURE INTEGRITY OF THE PRODUCT. THESE INSPECTIONS AND FUNCTIONAL CHECKS ARE OUTLINED IN INTERNAL PROCEDURES IN PLACE AT CIRL. FROM THE INFORMATION PROVIDED 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 · 0

    A FOLLOW-UP MDR IS BEING SUBMITTED TO INCLUDE THE DEVICE EVALUATION DETAILS. INITIAL REPORT DETAILS: WHILE PERFORMING EBUS-TBNA (3RD PASS) IN STATION 11 THE NEEDLE BENT. THE SCOPE WAS REMOVED WITH THE NEEDLE INSIDE AND IT WAS NOTICED THE NEEDLE WAS BROKEN.

    Description of Event or Problem · 0

    WHILE PERFORMING EBUS-TBNA (3RD PASS) IN STATION 11 THE NEEDLE BENT. THE SCOPE WAS REMOVED WITH THE NEEDLE INSIDE AND IT WAS NOTICED THE NEEDLE WAS BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236766 ECHOTIP ULTRA ENDOBRONCHIAL HD ULTRASOUND NEEDLE FCG KIT, NEEDLE, BIOPSY FCG COOK IRELAND LTD 00827002534087

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention