BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHOTIP PROCORE ENDOBRONCHIAL HD BIOPSY NEEDLE

    MDR report key: 7181570 · Received January 11, 2018

    Report

    Report Number
    3001845648-2018-00014
    Event Type
    Malfunction
    Date Received
    January 11, 2018
    Date of Event
    December 5, 2017
    Report Date
    December 15, 2017
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FCG
    UDI-DI
    00827002342811
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    510(K) NUMBER: K160229. 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. THE ECHO-HD-22-EBUS-O-C DEVICE INVOLVED IN THIS COMPLAINT WILL NOT BEEN RETURNED FOR EVALUATION. WITH THE LIMITED INFORMATION PROVIDED, A DOCUMENT BASED INVESTIGATION WAS CARRIED OUT. AS THE DEVICE WAS NOT RETURNED FOR EVALUATION AND CONDITIONS OF DEVICE USAGE CANNOT BE REPLICATED IN THE LABORATORY IT IS NOT POSSIBLE TO CONCLUSIVELY DETERMINE THE ROOT CAUSE OF THIS COMPLAINT. THE CUSTOMER COMPLAINT IS CONSIDERED CONFIRMED BASED ON CUSTOMER TESTIMONY. ROOT CAUSE: A POSSIBLE ROOT CAUSE FOR THIS OCCURRENCE MAY BE THAT EXCESSIVE FORCE MAY HAVE BEEN USED CAUSING THE DEVICE TO DAMAGE SCOPE. AS PER THE ADDITIONAL INFORMATION RECEIVED, CAN YOU PLEASE CLARIFY WITH THE CUSTOMER IF IT¿S THE ACTUAL NEEDLE THAT DAMAGED/PUNCTURED THE SCOPE? IT¿S UNKNOWN WHAT CAUSED THE DAMAGE. THE PRECAUTIONS SECTION OF THE INSTRUCTIONS FOR USE IFU0109-5 THAT ACCOMPANIES THIS DEVICE INSTRUCTS THE USER TO INSPECT THE DEVICE PRIOR TO USE FOR ANY DAMAGE: ¿THE NEEDLE MUST BE RETRACTED INTO (DIMPLED ECHO-HD-22-EBUS-O-C) QC#CH THE SHEATH AND THE THUMBSCREW IN THE SAFETY RING MUST BE LOCKED AT THE 0 CM MARK TO HOLD THE NEEDLE IN PLACE PRIOR TO INTRODUCTION, ADVANCEMENT OR WITHDRAWAL OF THE DEVICE. FAILURE TO RETRACT THE NEEDLE MAY RESULT IN DAMAGE TO THE ENDOSCOPE.¿ IN THE INSTRUCTIONS FOR USE SECTION IT IS MENTIONED; ¿CAUTION: DURING NEEDLE ADJUSTMENT OR EXTENSION, ENSURE THE DEVICE HAS BEEN ATTACHED TO THE ACCESSORY CHANNEL OF THE ENDOSCOPE. FAILURE TO ATTACH THE DEVICE PRIOR TO NEEDLE ADJUSTMENT OR EXTENSION MAY RESULT IN DAMAGE TO THE ENDOSCOPE.¿ AND IN THE NOTES SECTION OF THE INSTRUCTIONS FOR USE IT IS ALSO MENTIONED 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". PRIOR TO DISTRIBUTION, ALL ECHO DEVICES ARE SUBJECTED TO FUNCTIONAL CHECKS AND 100% VISUAL INSPECTION TO ENSURE INTEGRITY OF THE PRODUCT. THESE INSPECTIONS AND FUNCTIONAL CHECKS ARE OUTLINED IN INTERNAL PROCEDURES IN PLACE AT CIRL. ALL PRODUCTS AND PACKAGING ARE 100% INSPECTED FOR VISUAL IRREGULARITIES SUCH AS HOLES, DENTS, KINKS OR TEARS. THE MANUFACTURING RECORDS OF THE DEVICE INVOLVED IN THIS COMPLAINT WAS REVIEWED AS THE LOT NUMBER C1373175 OF THE COMPLAINT DEVICE DID NOT SHOW ANY DISCREPANCIES WHICH WOULD RELATE TO THIS COMPLAINT. THERE IS NO EVIDENCE TO SUGGEST THAT THIS ISSUE EFFECTS THE ENTIRE LOT # C1373175; UPON REVIEW OF COMPLAINTS THIS FAILURE MODE HAS NOT OCCURRED PREVIOUSLY WITH THIS LOT # C1373175. 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

    ON (B)(6) 2017 - THE PHYSICIAN WAS ATTEMPTING TO SAMPLE NODES 7 AND 10 R AND EXPERIENCED A LITTLE DIFFICULTY ADVANCING THE NEEDLE ALL THE WAY THROUGH THE SCOPE. UPON STRAIGHTENING THE SCOPE FURTHER, ADVANCEMENT OF NEEDLE TO HUB WAS ACHIEVED. THE SAMPLE AT SITE WAS PERFORMED AND UPON CLEANING SCOPE, AN AIR LEAK WAS NOTED AT THE DISTAL END APPROXIMATELY ONE AND A HALF INCHES OF THE SCOPE. THE SCOPE CHANNEL WAS DAMAGED AND PUNCTURED. THE PHYSICIAN LOVES THE NEEDLE AS IT OBTAINS ADEQUATE SAMPLING ON 1ST OR 2ND PASS. DM MET WITH ONE OF THE PHYSICIANS AND DISCUSSED USING A 25 GAUGE NEEDLE FOR LYMPH NODE #7 SAMPLING DUE TO FLEXIBILITY OVER NEEDLE OVER THE 22 GAUGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    25193 ECHOTIP PROCORE ENDOBRONCHIAL HD BIOPSY NEEDLE FCG KIT, NEEDLE, BIOPSY FCG COOK IRELAND LTD G34281 00827002342811

    Patients

    Seq Age Sex Outcome Treatment
    1