BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECHOTIP ULTRA ENDOSCOPIC ULTRASOUND NEEDLE

    MDR report key: 8984217 · Received September 10, 2019

    Report

    Report Number
    3001845648-2019-00462
    Event Type
    Injury
    Date Received
    September 10, 2019
    Date of Event
    August 13, 2019
    Report Date
    October 4, 2019
    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
    CN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    PMA/510(K) # K083330 1 X ECHO-19 OF LOT # C1580980 WAS RETURNED TO CIRL FOR EVALUATION OPEN IN ITS ORIGINAL PACKAGING. WITH THE INFORMATION PROVIDED, A PHYSICAL EXAMINATION AND DOCUMENT BASED INVESTIGATION WAS CONDUCTED. THE DEVICE RELATED TO THIS OCCURRENCE UNDERWENT A LABORATORY EVALUATION. THE NEEDLE WAS FOUND TO BE BROKEN APPROXIMATELY 5.8 CM FROM TIP OF SHEATH. THE NEEDLE WAS FOUND TO BE KINKED DISTALLY. THE KINK AT DISTAL END MOST LIKELY A CASCADING EFFECT OF THE NEEDLE BREAK. 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 C1580980 DID NOT REVEAL ANY DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT ISSUE. 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. 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 ADVANCEMENT INTO A HARD LESION. AS PER ADDITIONAL INFORMATION RECEIVED NEEDLE PENETRATION OF THE TARGETED SITE WAS DIFFICULT. 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 NEEDLE BROKE DURING THE PROCEDURE. A CORRECTION REPORT IS BEING SUBMITTED TO CLASSIFY THIS REPORT UNDER SERIOUS INJURY. ADOPTING A CAUTIOUS APPROACH, SERIOUS INJURY REPORTING REQUIRED AS THE NEEDLE BROKE INSIDE THE PATIENT'S BODY AND THERE IS POTENTIALLY A REQUIREMENT FOR SURGICAL INTERVENTION. THE RISK OF THIS COMPLAINT WAS ASSESSED BASED ON A SEVERITY OF +3 (HARM REQUIRING MEDICAL INTERVENTION). IT SHOULD BE NOTED THAT THESE DETAILS DO NOT IMPACT THE EVALUATION CONCLUSIONS PREVIOUSLY SUBMITTED IN RELATION TO THIS EVENT.

    Additional Manufacturer Narrative · 1

    PMA/510(K) # K083330. 1 X ECHO-19 OF LOT # C1580980 WAS RETURNED TO CIRL FOR EVALUATION OPEN IN ITS ORIGINAL PACKAGING. WITH THE INFORMATION PROVIDED, A PHYSICAL EXAMINATION AND DOCUMENT BASED INVESTIGATION WAS CONDUCTED. THE DEVICE RELATED TO THIS OCCURRENCE UNDERWENT A LABORATORY EVALUATION. THE NEEDLE WAS FOUND TO BE BROKEN APPROXIMATELY 5.8 CM FROM TIP OF SHEATH. THE NEEDLE WAS FOUND TO BE KINKED DISTALLY. THE KINK AT DISTAL END MOST LIKELY A CASCADING EFFECT OF THE NEEDLE BREAK. 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 C1580980 DID NOT REVEAL ANY DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT ISSUE. 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. 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 ADVANCEMENT INTO A HARD LESION. AS PER ADDITIONAL INFORMATION RECEIVED NEEDLE PENETRATION OF THE TARGETED SITE WAS DIFFICULT. 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 · 1

    THE NEEDLE BROKE DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    780658 ECHOTIP ULTRA ENDOSCOPIC ULTRASOUND NEEDLE FCG KIT, NEEDLE, BIOPSY FCG COOK IRELAND LTD G31520 C1580980 00827002315204

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention