BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHOTIP ULTRA ENDOSCOPIC ULTRASOUND NEEDLE

    MDR report key: 16751130 · Received April 17, 2023

    Report

    Report Number
    3001845648-2023-00238
    Event Type
    Malfunction
    Date Received
    April 17, 2023
    Date of Event
    February 24, 2023
    Report Date
    August 31, 2023
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FCG
    UDI-DI
    10827002315201
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    PMA 510K #K210476. DEVICE EVALUATION 1 UNIT OF LOT C1970502 OF ECHO-19 WAS RETURNED OPENED IN ITS ORIGINAL PACKAGING. THE DEVICE RELATED TO THIS OCCURRENCE UNDERWENT A LABORATORY EVALUATION. FUNCTIONAL INSPECTION: SHEATH EXTENDER ABLE TO ADVANCE AND RETRACT WITH NO ISSUE NEEDLE ABLE TO ADVANCE AND RETRACT WITH NO ISSUE. VISUAL INSPECTION: DISTAL END OF NEEDLE EXAMINED AND NO ISSUE OBSERVED SHEATH OBSERVED TO BE BROKEN AT THE TIP OF THE SHEATH. MANUFACTURING RECORDS REVIEW 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 C1970502 DID NOT REVEAL ANY DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT ISSUE. HISTORICAL DATA REVIEW 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 C1970502. 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". ALSO, ¿INTENDED USE: THIS DEVICE IS USED TO SAMPLE TARGETED SUBMUCOSAL GASTROINTESTINAL LESIONS THROUGH THE ACCESSORY CHANNEL OF AN ULTRASOUND ENDOSCOPE.¿ THERE IS NO EVIDENCE TO SUGGEST THAT THE CUSTOMER DID NOT FOLLOW THE INSTRUCTIONS FOR USE (IFU0101). IMAGE REVIEW AN IMAGE WAS NOT RETURNED FOR EVALUATION. ROOT CAUSE REVIEW 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 IF THE DEVICE WAS BEING USED IN A FLEXED OR TWISTED POSITION IT MAY HAVE CAUSED DIFFICULTY IN THE NEEDLE ADVANCEMENT THROUGH THE SCOPE AND THE SHEATH MAY ALSO HAVE GOT CAUGHT AT THE END OF THE SCOPE MAKING IT DIFFICULT TO GET IT TO EXIT AND CAUSING THE NEEDLE TO PIERCE THE SHEATH. THE IFU INSTRUCTS THE USER TO REDUCE ANGULATION WHERE RESISTANCE IS ENCOUNTERED. AS PER IFU0101 IF ANY RESISTANCE IS ENCOUNTERED ON NEEDLE INTRODUCTION, THE USER SHOULD REDUCE ANGULATION OF THE SCOPE UNTIL SMOOTH PASSAGE IS POSSIBLE. SUMMARY COMPLAINT IS CONFIRMED BASED ON VISUAL AND/OR FUNCTIONAL INSPECTION. 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

    USER ADVANCED THE NEEDLE INTO ENDOSCOPY WORKING CHANNEL. FOUND OUT THE NEEDLE CANNOT BE ADVANCED AS EXPECTED (NEEDLE WAS NOT ADVANCED INTO PATIENT). USER THEN RETRACTED THE NEEDLE FROM ENDOSCOPY AND FOUND OUT THE DISTAL END OF NEEDLE SHEATH BROKEN. USER SUSPICIOUS THE ISSUE WAS EXISTED BEFORE USE WHICH RESULT IN NEEDLE ADVANCEMENT DIFFICULTY. PATIENT OUTCOME: N/A. THIS OBSERVATION WAS MADE PRIOR TO PATIENT CONTACT. PATIENT/EVENT INFO NOTES: N/A. THIS OBSERVATION WAS MADE PRIOR TO PATIENT CONTACT.

    Description of Event or Problem · 0

    THIS FOLLOW UP MDR IS BEING SUBMITTED TO CAPTURE THE LAB EVALUATION CONDUCTED ON 26-APR-2023.

    Description of Event or Problem · 0

    THIS FOLLOW UP MDR IS BEING SUBMITTED TO CAPTURE THE COMPLETION OF THE INVESTIGATION ON 31-AUG-2023.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1818432 ECHOTIP ULTRA ENDOSCOPIC ULTRASOUND NEEDLE FCG KIT, NEEDLE, BIOPSY FCG COOK IRELAND LTD C1970502 10827002315201

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown