BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHOTIP PROCORE HIGH DEFINITION ULTRASOUND BIOPSY NEEDLE

    MDR report key: 6489392 · Received April 13, 2017

    Report

    Report Number
    3001845648-2017-00127
    Event Type
    Malfunction
    Date Received
    April 13, 2017
    Date of Event
    March 17, 2017
    Report Date
    March 17, 2017
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FCG
    UDI-DI
    00827002347854
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KR
    Reporter Occupation
    OTHER

    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) #K142688. 1 X ECHO-HD-3-20-C LOT NUMBER C1266857 WAS RETURNED TO CIRL FOR EVALUATION. UPON EVALUATION OF THE RETURNED DEVICE, IT WAS NOTED THAT THE NEEDLE WAS OUT OF THE SHEATH ON RETURN. THE NEEDLE WAS PULLED OUT OF SHEATH, IT WAS NOTED THAT IT WAS BROKEN BELOW THE SHEATH EXTENDER AT POSITION 3 PROXIMAL END. THIS COULD HAVE BEEN POSSIBLY FROM REMOVING FROM THE PACKAGING OR PLACING THE DEVICE INTO THE SCOPE. THE CUSTOMER COMPLAINT IS CONSIDERED TO BE CONFIRMED DUE TO NEEDLE BROKEN. THE MANUFACTURING RECORDS OF THE DEVICE INVOLVED IN THIS COMPLAINT C1266857 DID NOT REVEAL ANY DISCREPANCIES. PRIOR TO DISTRIBUTION, ALL ECHO 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. THE INSTRUCTIONS FOR USE, IFU0077-4, ADVISES THE USER TO ¿VISUALLY INSPECT WITH PARTICULAR ATTENTION TO KINKS, BENDS OR BREAKS. IF AN ABNORMALITY IS DETECTED THAT WOULD PROHIBIT PROPER WORKING CONDITION, DO NOT USE¿. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 0

    AFTER THE FIRST PUNCTURE, THE NEEDLE WAS NOT ABLE TO WITHDRAW. ALTHOUGH THE SAFETY RING IS THE POSITION ¿0¿, THE NEEDLE IS STILL FULLY OUT OF THE SHEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271386 ECHOTIP PROCORE HIGH DEFINITION ULTRASOUND BIOPSY NEEDLE FCG KIT, NEEDLE, BIOPSY FCG COOK IRELAND LTD 00827002347854

    Patients

    Seq Age Sex Outcome Treatment
    1