BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECHOTIP ULTRA ENDOSCOPIC ULTRASOUND NEEDLE

    MDR report key: 17835559 · Received September 28, 2023

    Report

    Report Number
    3001845648-2023-00745
    Event Type
    Injury
    Date Received
    September 28, 2023
    Date of Event
    August 28, 2023
    Report Date
    May 1, 2024
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FCG
    UDI-DI
    10827002315201
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PMA/510(K) #K210476. INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.

    Additional Manufacturer Narrative · 0

    PMA/510(K) # K210476 DEVICE EVALUATION: THE ECHO-19 DEVICE OF LOT NUMBER C2009847 WAS RETURNED FOR EVALUATION, OPENED WITH 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 ON 16 NOVEMBER 2023. THE RETURNED DEVICE LAB FINDINGS AND OBSERVATIONS CAN BE REFERRED THROUGH THE ATTACHED FILES. ON EVALUATION OF THE DEVICE THE BELOW WAS OBSERVED: VISUAL INSPECTION: DISTAL END OF NEEDLE EXAMINED AND OBSERVED TO BE BROKEN APPROX. 8CM FROM THE TIP OF THE SHEATH, STYLET REMOVED FROM THE DEVICE WITHOUT ISSUE, STYLET EXAMINED AND NO ISSUES OBSERVED, STYLET REINSERTED INTO DEVICE BUT DOES NOT REINSERT FULLY, NEEDLE REMOVED FROM THE DEVICE AND NO OTHER ISSUES OBSERVED APART FROM THE DISTAL BREAK. FUNCTIONAL INSPECTION: SHEATH EXTENDER ABLE TO ADVANCE AND RETRACT WITHOUT ISSUE, NEEDLE ABLE TO ADVANCE AND RETRACT WITHOUT ISSUE. CUSTOMER ATTACHED IMAGES AND THE DISTAL END OF THE NEEDLE IS OBSERVED TO BE BROKEN. CLARIFICATION WAS REQUESTED FROM CUSTOMER AS BELOW: WOULD YOU BE ABLE TO ADVISE WHERE THE MISSING PIECE IS? THE MISSING PIECE WAS DISCARDED BY USER FACILITY. WOULD YOU CONFIRM THAT NO PIECE DETACHED INSIDE THE PATIENT? YES IF THE PIECE DID NOT DETACH INSIDE THE PATIENT, WOULD YOU PLEASE CONFIRM WITH THE CUSTOMER THAT THE MISSING PIECE IS NOT IN THE ENDOSCOPE? NO. MANUFACTURING RECORDS: PRIOR TO DISTRIBUTION, ALL ECHO-19 DEVICES ARE SUBJECTED TO FUNCTIONAL CHECKS AND VISUAL INSPECTION TO ENSURE DEVICE INTEGRITY. A REVIEW OF THE MANUFACTURING RECORDS FOR ECHO-19 OF LOT NUMBER C2009847DID NOT REVEAL ANY DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT ISSUE. REVIEW HISTORICAL DATA: THE REVIEW OF RELEVANT MANUFACTURING RECORDS CONFIRMS THE FAILURE MODE HAS NOT PREVIOUSLY OCCURRED WITH LOT NUMBER C2009847. INSTRUCTIONS FOR USE AND/LABEL: THE NOTES SECTION OF THE INSTRUCTIONS FOR USE, IFU0101 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. IMAGE REVIEW: AN IMAGE WAS NOT RETURNED FOR EVALUATION. ROOT CAUSE ANALYSIS: A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED AS THE CIRCUMSTANCES OF USE CANNOT BE REPLICATED IN THE LABORATORY. A POSSIBLE ROOT CAUSE COULD BE ATTRIBUTED TO THE NEEDLE BREAKING AT INSERTION DOWN THE SCOPE DURING ENDOSCOPY CHANNEL ADVANCEMENT DUE TO THE POSITIONING OF THE DEVICE / THE ANGLE AT WHICH DEVICE WAS HELD DURING ADVANCEMENT AS IT IS STATED IN THE ADDITIONAL INFORMATION THAT THE USER HAD DIFFICULTY IN ATTACHING/DETACHING THE DEVICE TO THE ACCESSORY CHANNEL PORT ON THE SCOPE. ANOTHER POSSIBLE ROOT CAUSE COULD BE ATTRIBUTED TO THE DISTAL NEEDLE BREAK OCCURRING AS USER WAS RETRACTING THE DEVICE AS IT IS STATED THAT USER EXPERIENCED DIFFICULTIES WHILE RETRACTING THE NEEDLE AND THE USER WAS UNABLE TO BE FULLY RETRACT THE NEEDLE BEFORE REMOVING IT FROM THE PATIENT. CONFIRMATION OF COMPLAINT: COMPLAINT IS CONFIRMED BASED ON VISUAL AND/OR FUNCTIONAL INSPECTION. CORRECTIVE ACTION/ CORRECTION: COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS. SUMMARY OF INVESTIGATION: ACCORDING TO THE CUSTOMER, USER OPENED THE PACKAGE AND ADVANCED THE DEVICE THROUGH ENDOSCOPY WORKING CHANNEL TO DESIRED POSITION WHILE FOUND OUT THE NEEDLE CANNOT BE PULLED OUT AND THE DISTAL END OF NEEDLE BROKEN. CONFIRMED QUANTITY OF 01 DEVICE, CONFIRMED USED. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. INVESTIGATION FINDINGS CONCLUDE THAT, A POSSIBLE ROOT CAUSE COULD BE ATTRIBUTED TO THE NEEDLE BREAKING AT INSERTION DOWN THE SCOPE DURING ENDOSCOPY CHANNEL ADVANCEMENT DUE TO THE POSITIONING OF THE DEVICE / THE ANGLE AT WHICH DEVICE WAS HELD DURING ADVANCEMENT AS IT IS STATED IN THE ADDITIONAL INFORMATION THAT THE USER HAD DIFFICULTY IN ATTACHING/DETACHING THE DEVICE TO THE ACCESSORY CHANNEL PORT ON THE SCOPE. ANOTHER POSSIBLE ROOT CAUSE COULD BE ATTRIBUTED TO THE DISTAL NEEDLE BREAK OCCURRING AS USER WAS RETRACTING THE DEVICE AS IT IS STATED THAT USER EXPERIENCED DIFFICULTIES WHILE RETRACTING THE NEEDLE AND THE USER WAS UNABLE TO BE FULLY RETRACT THE NEEDLE BEFORE REMOVING IT FROM THE PATIENT. COMPLAINT IS CONFIRMED BASED ON VISUAL AND/OR FUNCTIONAL INSPECTION.

    Description of Event or Problem · 0

    USER OPENED THE PACKAGE AND ADVANCED THE DEVICE THROUGH ENDOSCOPY WORKING CHANNEL TO DESIRED POSITION WHILE FOUND OUT THE NEEDLE CANNOT BE PULLED OUT AND THE DISTAL END OF NEEDLE BROKEN. USER THEN CHANGED TO ANOTHER SAME DEVICE TO COMPLETE THE PROCEDURE. "A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE."

    Description of Event or Problem · 0

    SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON 01-MAY-2024.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2246324 ECHOTIP ULTRA ENDOSCOPIC ULTRASOUND NEEDLE FCG KIT, NEEDLE, BIOPSY FCG COOK IRELAND LTD C2009847 10827002315201

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Male Required Intervention