BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHOTIP ULTRA ENDOSCOPIC ULTRASOUND NEEDLE

    MDR report key: 8094724 · Received November 21, 2018

    Report

    Report Number
    3001845648-2018-00536
    Event Type
    Malfunction
    Date Received
    November 21, 2018
    Date of Event
    October 9, 2018
    Report Date
    November 21, 2018
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FCG
    UDI-DI
    00827002315204
    PMA / PMN Number
    K083330
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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. INVESTIGATION IS STILL PENDING. A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.

    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)(6). (B)(4). IMPORTER SITE ESTABLISHMENT REGISTRATION NUMBER: (B)(4). LAB EVALUATION: THE DEVICE RELATED TO THIS OCCURRENCE UNDERWENT A LABORATORY EVALUATION ON 28 NOV 2018. THE NEEDLE WAS FOUND TO BE BROKEN PROXIMALLY TO THE SHEATH EXTENDER. A FURTHER ISSUE OF NEEDLE TIP BENT WAS ALSO NOTED DURING THE LAB EVALUATION. ANOTHER PR ((B)(4)) WAS OPENED UP FOR THIS EXTRA FAILURE MODE. A KINK WAS ALSO OBSERVED APPROX. 12.2CM FROM THE NEEDLE TIP BUT THIS WAS DETERMINED TO BE A CASCADING EFFECT OF THE NEEDLE TIP BENT POSSIBLY DUE TO HARD LESION. 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. A REVIEW OF THE MANUFACTURING RECORDS FOR ECHO-19 OF LOT NUMBER C1439655 DID NOT REVEAL ANY DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT ISSUE. THE REVIEW OF RELEVANT MANUFACTURING RECORDS, CONFIRMS THE FAILURE MODE HAS NOT PREVIOUSLY OCCURRED WITH THE CURRENT LOT NUMBER. BASED ON THE INFORMATION AVAILABLE TO DATE, THERE IS NO EVIDENCE TO SUGGEST THAT THERE ARE ANY MANUFACTURING ISSUES ASSOCIATED WITH LOT NUMBER C1439655. IFU REVIEW: THE NOTES SECTION OF THE INSTRUCTIONS FOR USE, IFU0101-0 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 (IFU0101-0). ROOT CAUSE REVIEW: THE FAILURE OF NEEDLE BROKEN WAS OBSERVED IN THE LABORATORY. 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 DEVICE HANDLING OR EXCESSIVE FORCE BEING APPLIED CAUSING THE NEEDLE BREAKAGE WHEN ATTACHING OR DETACHING THE DEVICE TO THE SCOPE. SUMMARY: 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

    IMPOSSIBLE TO RE-ENTER THE NEEDLE INSIDE THE SHEATH AFTER USE (2ND USE), CHANGE OF NEEDLE ( BRAND) TO BE ABLE TO PERFORM THE 2ND PUNCTION. PATIENT INJURY TO BE CONFIRMED. DEVICE AVAILABLE.

    Description of Event or Problem · 0

    IMPOSSIBLE TO RE-ENTER THE NEEDLE INSIDE THE SHEATH AFTER USE (2ND USE), CHANGE OF NEEDLE ( BRAND) TO BE ABLE TO PERFORM THE 2ND PUNCTION. PATIENT INJURY TO BE CONFIRMED. DEVICE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    936350 ECHOTIP ULTRA ENDOSCOPIC ULTRASOUND NEEDLE FCG KIT, NEEDLE, BIOPSY FCG COOK IRELAND LTD G31520 C1439655 00827002315204

    Patients

    Seq Age Sex Outcome Treatment
    1