BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHOTIP PROCORE HIGH DEFINITION ULTRASOUND BIOPSY NEEDLE

    MDR report key: 7442671 · Received April 19, 2018

    Report

    Report Number
    3001845648-2018-00177
    Event Type
    Malfunction
    Date Received
    April 19, 2018
    Date of Event
    March 1, 2018
    Report Date
    April 19, 2018
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FCG
    UDI-DI
    00827002347854
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    510(K) NUMBER: K142688. 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. INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE INVESTIGATION CONCLUSIONS.

    Additional Manufacturer Narrative · 0

    510(K) NUMBER: K142688. (B)(4). EXEMPTION NUMBER: E2016031. (B)(4). DEVICE EVALUATION: THE ECHO-HD-3-20-C OF LOT NUMBER C1351060 DEVICES INVOLVED IN THIS COMPLAINT WAS RETURNED FOR EVALUATION, WITHOUT ORIGINAL PACKAGING. WITH THE INFORMATION PROVIDED, A PHYSICAL EXAMINATION AND DOCUMENT BASED INVESTIGATION WAS CONDUCTED. THE COMPLAINT DEVICE UNDERWENT A LABORATORY EVALUATION, THIS COMPLAINT FILE IS CAPTURING THE SECOND FAILURE MODE, PROXIMAL NEEDLE KINK. ON EVALUATION OF THE RETURNED DEVICE IT WAS OBSERVED THAT THE DEVICE WAS RETURNED WITHOUT ITS ORIGINAL PACKAGING. TEST TUBE WITH FOREIGN MATTER RETURNED. THE STYLET IS FULLY IN PLACE ON BOTH DEVICES ¿ NO NEEDLE EXPOSURE. DEVICE ONE, NEEDLE ADVANCES AND RETRACTS WITHOUT ISSUE. BEND BELOW SHEATH EXTENDER NOTED. FLUSHED DEVICE AND SEEMS TO BE BLOCKED. STYLET WAS TAKEN OUT AND RE-INSERTED WITH "DIFFABILITY". DEVICE TWO, THE NEEDLE ADVANCES AND RETRACTS WITHOUT ISSUE. NO ISSUES NOTED WITH NEEDLE. DEVICE WAS FLUSHED AND BLACK PARTICLES PRESENT. STYLETS WILL NOT RE INSERT PASS THE KINK AT PROXIMAL END. THE COMPLAINT DEVICE UNDERWENT AN ADDITIONAL LABORATORY EVALUATION, PHOTOS TAKEN DURING ORIGINAL LAB EVALUATION SHOWED A DISTAL KINK ON DEVICE. THIS WAS CONFIRMED AND ADDITIONAL PHOTOS WERE TAKEN OF BOTH DEVICES AND ADDITIONAL PR HAS BEEN REQUESTED TO ADDRESS THE DISTAL NEEDLE KINK. THE CUSTOMER COMPLAINT IS CONSIDERED TO BE CONFIRMED BASED ON LABORATORY FINDINGS. THERE WAS A KINK IN THE NEEDLE PROXIMALLY BELOW THE SHEATH EXTENDER. ROOT CAUSE: A DEFINITIVE ROOT CAUSE FOR THE CUSTOMER COMPLAINT COULD NOT BE DETERMINED AS THE EXACT OPERATIONAL CONDITIONS OF USE COULD NOT BE REPLICATED IN THE LABORATORY SETTING. HOWEVER IT IS POSSIBLE THAT EXCESSIVE FORCE WAS APPLIED (VISIBLE DAMAGE ON SHEATH WERE KINK IS WAS NOTED) CAUSING THE NEEDLE TO KINK WHEN ATTACHING OR DETACHING THE DEVICE TO THE SCOPE. A CAPA HAS BEEN INITIATED TO DOCUMENT AND TRACK THE ACTIONS TAKEN TO INVESTIGATE AND TO ADDRESS KINKING OR BREAKING OF THE SHEATH AT THE SHEATH/SHEATH EXTENDER JUNCTION. DOCUMENTS REVIEW: A REVIEW OF THE QC RECORDS DID NOT REVEAL ANY ISSUES WHICH COULD HAVE CONTRIBUTED TO THIS COMPLAINT ISSUE. PRIOR TO DISTRIBUTION, ALL ECHO-HD-3-20-C 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 (B)(4). THE NOTES SECTION OF THE INSTRUCTIONS FOR USE, IFU0077-4, WHICH ACCOMPANIES THIS DEVICE INSTRUCTS THE USER TO INSPECT THE DEVICE PRIOR TO USE FOR ANY DAMAGE: "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 (IFU0077-4 ). A REVIEW OF THE MANUFACTURING RECORDS FOR ECHO-HD-3-20-C DEVICE OF LOT# C1387307 DID NOT REVEAL ANY DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT ISSUE. THERE IS NO EVIDENCE TO SUGGEST THAT THIS ISSUE AFFECTS THE ENTIRE LOT # C1387307; UPON REVIEW OF COMPLAINTS THIS FAILURE MODE HAS NOT OCCURRED PREVIOUSLY WITH THIS LOT # C1387307. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 0

    PROXIMAL NEEDLE KINK WAS NOTED DURING LAB EVALUATION FOR A DIFFERENT COMPLAINT ISSUE.

    Description of Event or Problem · 0

    PROXIMAL NEEDLE KINK WAS NOTED DURING LAB EVALUATION FOR A DIFFERENT COMPLAINT ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    288469 ECHOTIP PROCORE HIGH DEFINITION ULTRASOUND BIOPSY NEEDLE FCG KIT, NEEDLE, BIOPSY FCG COOK IRELAND LTD G34785 00827002347854

    Patients

    Seq Age Sex Outcome Treatment
    1