BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHOTIP PROCORE HIGH DEFINITION ULTRASOUND BIOPSY NEEDLE

    MDR report key: 7726080 · Received July 27, 2018

    Report

    Report Number
    3001845648-2018-00348
    Event Type
    Malfunction
    Date Received
    July 27, 2018
    Date of Event
    June 25, 2018
    Report Date
    July 27, 2018
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FCG
    UDI-DI
    00827002347854
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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. IMPORTER SITE ESTABLISHMENT REGISTRATION NUMBER: 3005580113. INVESTIGATION IS STILL PENDING, A FOLLOW UP REPORT WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.

    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 (B)(4). IMPORTER SITE ESTABLISHMENT REGISTRATION NUMBER: (B)(4). PROBLEM STATEMENT "THE NEELDL IS CURVED. AFTER THE DOCTOR SECOND PUNCHER THE NEEDLE IN, THE NEELDL IS CURVED, SO THEY CHANGE A NEW ONE.¿ DEVICE EVALUATION. THE ECHO-HD-3-20-C DEVICE OF LOT NUMBER C1458237 INVOLVED IN THIS COMPLAINT WAS RETURNED FOR EVALUATION, WITHOUT THE ORIGINAL PACKAGING. WITH THE INFORMATION PROVIDED, A PHYSICAL EXAMINATION AND DOCUMENT BASED INVESTIGATION WAS CONDUCTED. AS PER CUSTOMER TESTIMONY THE STYLET WAS NOT IN PLACE INSIDE THE NEEDLE WHEN ADVANCING INTO THE TARGETED SITE. THE DEVICE RELATED TO THIS OCCURRENCE UNDERWENT A LABORATORY EVALUATION ON THE 18 JULY 2018. ON EVALUATION OF THE RETURNED DEVICE, THE DEVICE WAS RETURNED WITHOUT THE ORIGINAL PACKAGING. KINK WAS IDENTIFIED AT THE NOTCH. THE KINK LOOKS LIKE THE NEEDLE WAS PINCHED. TIP OF NEEDLE BENT INWARDS. SYRINGE WAS MISSING. STYLET WILL NOT GO PASSED THE KINK. VISUAL AND FUNCTIONAL CHECKS WERE COMPLETED COMPLAINT IS CONFIRMED AS THE FAILURE WAS VERIFIED IN THE LABORATORY. ROOT CAUSE: THE ROOT CAUSE WAS THAT THE USER ERROR DID NOT FOLLOW THE INSTRUCTIONS FOR USE AS THE STYLET WAS NOT IN PLACE INSIDE THE NEEDLE WHEN ADVANCING INTO THE TARGETED SITE. AS PER INSTRUCTION FOR USE, PRECAUTIONS: ¿ENSURE THE STYLET IS FULLY INSERTED WHEN ADVANCING THE NEEDLE INTO THE BIOPSY SITE.¿ STYLET PROVIDES NEEDLE SUPPORT AND PROVIDES ADDITIONAL SUPPORT DURING PUNCTURE. THEREFORE HARD LESION/CONSISTENCY OF TARGETED AREA AS INDICATED LED TO NEEDLE KINK. DOCUMENT REVIEW 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 CIRL. INSTRUCTIONS FOR USE IFU0077-4 ¿ENSURE THE STYLET IS FULLY INSERTED WHEN ADVANCING THE NEEDLE INTO THE BIOPSY SITE¿ ¿REMOVE STYLET FROM THE NEEDLE BY GENTLY PULLING BACK ON THE PLASTIC HUB SEATED IN THE METAL FITTING OF NEEDLE HANDLE.¿ THERE IS 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 C1458237 REVEALED NO DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT ISSUE. THERE IS NO EVIDENCE TO SUGGEST THAT THIS ISSUE AFFECTS THE ENTIRE LOT # C1458237; UPON REVIEW OF COMPLAINTS THIS FAILURE MODE HAS NOT OCCURRED PREVIOUSLY WITH THIS LOT # C1458237. SUMMARY COMPLAINT IS CONFIRMED AS THE FAILURE WAS VERIFIED IN THE LABORATORY. THE RISK ASSOCIATED WITH THE COMPLAINT IS RISK CATEGORY III/NO RISK. 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

    AFTER THE DOCTOR SECOND PUNCHER THE NEEDLE IN, THE NEEDLE IS CURVED, SO THEY CHANGE A NEW ONE. ADDITIONAL INFORMATION RECEIVED TO CONFIRM THE STYLET WAS NOT FULLY INSERTED WHEN ADVANCING THE NEEDLE INTO THE TARGET SITE AND WAS COMPLETED "NON STYLET" METHOD.

    Description of Event or Problem · 0

    THIS FOLLOW UP REPORT IS BEING SUBMITTED TO INFORM THE FDA OF THE CONCLUSIONS INTO THE INVESTIGATION. INITIAL DESCRIPTION SUBMITTED AS FOLLOWS: AFTER THE DOCTOR SECOND PUNCHER THE NEEDLE IN, THE NEELDL IS CURVED, SO THEY CHANGE A NEW ONE ADDITIONAL INFORMATION RECEIVED TO CONFIRM THE STYLET WAS NOT FULLY INSERTED WHEN ADVANCING THE NEEDLE INTO THE TARGET SITE AND WAS COMPLETED "NON STYLET" METHOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    568891 ECHOTIP PROCORE HIGH DEFINITION ULTRASOUND BIOPSY NEEDLE FCG KIT, NEEDLE, BIOPSY FCG COOK IRELAND LTD G34785 C1458237 00827002347854

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR