BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECHOTIP ULTRA ENDOSCOPIC ULTRASOUND NEEDLE

    MDR report key: 8483689 · Received April 4, 2019

    Report

    Report Number
    3001845648-2019-00136
    Event Type
    Injury
    Date Received
    April 4, 2019
    Date of Event
    March 7, 2019
    Report Date
    April 4, 2019
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FCG
    UDI-DI
    00827002315204
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    PMA/510(K) # 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

    PMA/510(K)#: K083330. COOK IRELAND LTD (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI)(IMPORTER). EXEMPTION NUMBER: E2016031. INFORMATION PERTAINING TO MFR SITE AS FOLLOWS: IMPORTER SITE CONTACT AND ADDRESS: (B)(6). (B)(4). THIS FOLLOW UP REPORT IS BEING SUBMITTED DUE TO THE EVALUATION OF THE DEVICE INVOLVED IN THIS EVENT AND THE CONCLUSION OF THIS INVESTIGATION. (B)(4) UNIT OF LOT#: C1543515 OF ECHO-19 WAS RETURNED OPENED NOT IN ITS ORIGINAL PACKAGING. THE DEVICE RELATED TO THIS OCCURRENCE UNDERWENT A LABORATORY EVALUATION. THE NEEDLE WAS FOUND TO BE BROKEN PROXIMALLY BELOW THE SHEATH EXTENDER. 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: C1543515 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: C1543515. THE NOTES SECTION OF THE INSTRUCTIONS FOR USE, 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. THE FAILURE OF NEEDLE BROKEN WAS CONCLUDED FROM THE AVAILABLE INFORMATION. A DEFINITIVE ROOT CAUSE FOR THE CUSTOMER COMPLAINT COULD NOT BE DETERMINED AS CIRCUMSTANCES OF USE CANNOT BE REPLICATED IN THE LABORATORY. A POSSIBLE CAUSE COULD BE ATTRIBUTED TO EXCESSIVE FORCE BEING APPLIED CAUSING THE NEEDLE BREAKAGE WHEN ATTACHING OR DETACHING THE DEVICE TO THE SCOPE. 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

    THE ECHOTIP ULTRA 19G BROKE DURING THE PROCEDURE. IT WAS IMPOSSIBLE TO RETRACT THE NEEDLE IN ITS PROTECTION CATHETER. THEY HAD TO RETRIEVE THE NEEDLE IN 2 PARTS: THE NEEDLE THROUGH THE ENDOSCOPE EXTREMITY AND THE HANDLE THROUGH THE OPERATING CHANNEL. A GASTROSCOPY WAS PERFORMED TO CHECK IF THERE WAS A LESION: ALL CLEAR. PRODUCT AVAILABILITY TO BE CONFIRMED. AS PER COMPLAINT FORM: 'IT WAS IMPOSSIBLE TO RETRACT THE NEEDLE INTO THE SHEATH. IT'S SEEMS THAT THE NEEDLE BROKE IN THE PROXIMAL PART OF THE DEVICE'.

    Description of Event or Problem · 0

    THIS FOLLOW UP REPORT IS BEING SUBMITTED DUE TO THE EVALUATION OF THE DEVICE INVOLVED IN THIS EVENT AND THE CONCLUSION OF THIS INVESTIGATION. INITIAL REPORT DETAILS: THE ECHOTIP ULTRA 19G BROKE DURING THE PROCEDURE. IT WAS IMPOSSIBLE TO RETRACT THE NEEDLE IN ITS PROTECTION CATHETER. THEY HAD TO RETRIEVE THE NEEDLE IN 2 PARTS: THE NEEDLE THROUGH THE ENDOSCOPE EXTREMITY AND THE HANDLE THROUGH THE OPERATING CHANNEL. A GASTROSCOPY WAS PERFORMED TO CHECK IF THERE WAS A LESION: ALL CLEAR. PRODUCT AVAILABILITY TO BE CONFIRMED. AS PER COMPLAINT FORM: 'IT WAS IMPOSSIBLE TO RETRACT THE NEEDLE INTO THE SHEATH . IT'S SEEMS THAT THE NEEDLE BROKE IN THE PROXIMAL PART OF THE DEVICE.'

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    278823 ECHOTIP ULTRA ENDOSCOPIC ULTRASOUND NEEDLE FCG KIT, NEEDLE, BIOPSY FCG COOK IRELAND LTD G31520 C1543515 00827002315204

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention