BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHOTIP ULTRA ENDOSCOPIC ULTRASOUND NEEDLE

    MDR report key: 7989061 · Received October 22, 2018

    Report

    Report Number
    3001845648-2018-00495
    Event Type
    Malfunction
    Date Received
    October 22, 2018
    Date of Event
    August 27, 2018
    Report Date
    September 24, 2018
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FCG
    UDI-DI
    00827002315204
    PMA / PMN Number
    K083330
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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. DEVICE EVALUATION: THE ECHO-19 DEVICE OF LOT NUMBER C1457416 INVOLVED IN THIS COMPLAINT WAS NOT RETURNED FOR EVALUATION. WITH THE INFORMATION PROVIDED, A DOCUMENT BASED INVESTIGATION WAS CONDUCTED. ROOT CAUSE: THREE ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION BUT NO INFORMATION RECEIVED TO DATE. FROM THE INFORMATION RECEIVED THE ISSUE IS BELIEVED TO BE NEEDLE KINKED DISTALLY. HOWEVER THERE IS A POSSIBILITY THAT THE BEND COULD HAVE OCCURRED AS A RESULT OF MIS-HANDLING DURING DEVICE REMOVAL FROM THE PACKAGING. DOCUMENT REVIEW: 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. THE REVIEW OF RELEVANT INFORMATION, CONFIRMS THE FAILURE MODE OF NEEDLE KINKED/BENT HAS OCCURRED. IFU REVIEW: THE NOTES SECTION OF THE INSTRUCTIONS FOR USE, IFU0101-0, 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 (IFU0101-0). SUMMARY: COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. 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

    DURING THE PROCEDURE OF PUNCTURE, THE CATHETER BENDED IN ITS END, PREVENTING THE EXTERNALIZATION OF THE NEEDLE, PRECLUDING ITS USE AFTER SEVERAL MANEUVERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    832813 ECHOTIP ULTRA ENDOSCOPIC ULTRASOUND NEEDLE FCG KIT, NEEDLE, BIOPSY FCG COOK IRELAND LTD G31520 C1457416 00827002315204

    Patients

    Seq Age Sex Outcome Treatment
    1