BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHOTIP ULTRA ENDOSCOPIC ULTRASOUND NEEDLE

    MDR report key: 8319819 · Received February 8, 2019

    Report

    Report Number
    3001845648-2019-00044
    Event Type
    Malfunction
    Date Received
    February 8, 2019
    Date of Event
    November 30, 2018
    Report Date
    January 11, 2019
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FCG
    UDI-DI
    00827002315204
    PMA / PMN Number
    K083330
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 0

    510 (K) NUMBER; K083330. 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. TWO DEVICES RELATED TO THIS OCCURRENCE UNDERWENT A LABORATORY EVALUATION. THE NEEDLE WAS FOUND TO BE KINKED DISTALLY ON THE FIRST DEVICE ((B)(4) / 3001845648-2019-00042). TWO FURTHER FAILURES WERE OBSERVED ON THE SECOND DEVICE (PROXIMAL KINK AND KINK/BEND ON DISTAL END OF SHEATH). TWO ADDITIONAL REPORTS WERE OPENED FOR THESE FAILURES. THIS REPORT IS RELATED TO THE DISTAL KINK/BEND) AND (B)(4) / 3001845648-2019-00043 IS RELATED TO THE PROXIMAL KINK. THIS COMPLAINT DEALS WITH THE DISTAL KINK. PRIOR TO DISTRIBUTION, ALL ECHO-19 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-19 OF LOT NUMBER C1523364 DID NOT REVEAL ANY DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT ISSUE. THE REVIEW OF RELEVANT MANUFACTURING RECORDS, CONFIRMS THE FAILURE MODE HAS PREVIOUSLY OCCURRED WITH THE CURRENT LOT NUMBER. HOWEVER, THIS WAS WITH THE RELATED COMPLAINTS (B)(4). BASED ON THE INFORMATION AVAILABLE TO DATE, THERE IS NO EVIDENCE TO SUGGEST THAT THERE ARE ANY MANUFACTURING ISSUES ASSOCIATED WITH LOT NUMBER C1523364. THE NOTES SECTION OF THE INSTRUCTIONS FOR USE, WHICH ACCOMPANIES THIS DEVICE INSTRUCTS THE USER TO; "VISUALLY INSPECT WITH PARTICULAR ATTENTION TO KINKS, BENDS AND BREAKS. IF AN ABNORMALITY IS DETECTED THAT WOULD PROHIBIT PROPER WORKING CONDITION, DO NOT USE". THERE IS NO EVIDENCE TO SUGGEST THAT THE CUSTOMER DID NOT FOLLOW THE INSTRUCTIONS FOR USE. THE FAILURE OF NEEDLE KINKED/BENT WAS CONCLUDED FROM THE AVAILABLE INFORMATION. A DEFINITIVE ROOT CAUSE FOR THE CUSTOMER COMPLAINT COULD NOT BE DETERMINED AS CIRCUMSTANCES OF USE CANNOT BE REPLICATED IN THE LABORATORY. A POSSIBLE ROOT CAUSE COULD BE ATTRIBUTED TO A COMBINATION OF TORTUOUS ANATOMY AND THE DEVICE BEING USED IN A FLEXED OR TWISTED POSITION AS INDICATED IN THE ADDITIONAL INFORMATION. COMPLAINT IS CONFIRMED AS THE FAILURE WAS VERIFIED IN THE LABORATORY. ACCORDING TO THE INITIAL REPORTER, 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

    KINK/BEND ON DISTAL END OF SHEATH - NOTED DURING LAB EVALUATION OF RETURNED DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    117328 ECHOTIP ULTRA ENDOSCOPIC ULTRASOUND NEEDLE FCG COOK IRELAND LTD G31520 C1523364 00827002315204

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR