BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECHOTIP ULTRA ENDOSCOPIC ULTRASOUND NEEDLE

    MDR report key: 16511987 · Received March 9, 2023

    Report

    Report Number
    3001845648-2023-00163
    Event Type
    Injury
    Date Received
    March 9, 2023
    Date of Event
    February 7, 2023
    Report Date
    July 4, 2023
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FCG
    UDI-DI
    10827002315201
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    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: (B)(4) UNIT OF LOT C2002118 OF ECHO-19 WAS RETURNED OPENED IN ITS ORIGINAL PACKAGING. THE DEVICE RELATED TO THIS OCCURRENCE UNDERWENT A LABORATORY EVALUATION ON 05 APRIL 2023. VISUAL INSPECTION: - DISTAL END OF NEEDLE EXAMINED AND NEEDLE OBSERVED TO BE BROKEN APPROXIMATELY 7.8CM FROM THE TIP OF THE SHEATH (IPE0402). - STYLET NOT RETURNED WITH THE DEVICE. FUNCTIONAL INSPECTION: - SHEATH EXTENDER ABLE TO ADVANCE AND RETRACT WITHOUT ISSUE. - NEEDLE ABLE TO ADVANCE AND RETRACT WITHOUT ISSUE. 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 C2002118 DID NOT REVEAL ANY DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT ISSUE. HIISTORICAL 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 C2002118. INSTRUCTION FOR USE: 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 THE DEVICE BEING USED IN A TORTUROUS POSITION AS INDICATED BY THE CUSTOMER IN THE ADDITIONAL INFO PROVIDED "WAS THE DEVICE USED IN A TORTUOUS POSITION? YES". THIS LIKELY CAUSED THE NEEDLE TO KINK DISTALLY WEAKENING THE NEEDLE AND LEADING TO THE NEEDLE BREAKING ON REMOVAL FROM THE SCOPE OUTSIDE OF THE PATIENT AS DESCRIBED BY THE CUSTOMER. 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.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    THIS FOLLOW UP MDR IS BEING SUBMITTED TO CAPTURE THE LAB EVALUATION CONDUCTED ON (B)(6) 2023.

    Description of Event or Problem · 0

    A SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO COMPLETION OF THE INVESTIGATION ON 04-JUL-2023.

    Description of Event or Problem · 0

    ¿THE NEEDLE WAS BROKEN¿ "AS PER CC FORM": THE TIP OF THE NEEDLE BROKE PATIENT OUTCOME: A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ANOTHER NEEDLE WAS USED ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE FOR THE QUESTIONNAIRE, I FORWARDED THIS TO PROF. VAN DER MERWE AS I WAS NOT PRESENT DURING THE PROCEDURE. WHEN I GOT A FEEDBACK FROM HIM, I'LL SEND IN THE QUESTIONNAIRE. 01/03/2023. I FORWARDED THIS QUESTIONNAIRE TO THE PROFESSOR BUT I DON¿T GET AN ANSWER. SO I TRIED TO FILL IN AS MUCH AS POSSIBLE FROM THE INFORMATION I OBTAINED FROM THE NURSE. 1. ARE IMAGES OF THE DEVICE OR PROCEDURE AVAILABLE? NO. 2. IF THE REPORT INVOLVES A KINK OR BEND IN THE NEEDLE, WHERE IS THIS LOCATED ON THE DEVICE (HANDLE END (PROXIMAL END) OR PATIENT END (DISTAL END))? PATIENT END. 3. WERE ANY OTHER DEFECTS (OTHER THAN THE COMPLAINT ISSUE) OBSERVED ON THE DEVICE PRIOR TO RETURN (E.G. KINK)? NO. PLEASE SPECIFY IF YES. 4. IF THE DEVICE WAS KINKED BELOW THE SHEATH EXTENDER, WAS THE KINK OBSERVED BEFORE INSERTING THE DEVICE INTO THE SCOPE? NO. 5. IF THE DEVICE IS A PROCORE NEEDLE, IS THE DEVICE DAMAGE LOCATED AT THE NOTCH / CORE TRAP? N/A. IF NO, PLEASE SPECIFY WHERE THE DAMAGE IS LOCATED: _____________________. 6. WAS GAINING ACCESS TO THE TARGET SITE DIFFICULT? NO. 7. WAS THE DEVICE USED IN A TORTUOUS POSITION? YES. 8. WAS PUNCTURE OF THE TARGET SITE DIFFICULT? N/A. 9. PLEASE DESCRIBE THE ANATOMICAL LOCATION OF THE INTENDED TARGET SITE (PANCREAS.). A. IF THE LUNGS, WHICH LYMPH NODE WAS BEING TARGETED? E.G. 4R, 11R, 12L ETC. 10. PLEASE DESCRIBE THE SIZE OF THE INTENDED TARGET SITE. 11. IF NOT WITH THE DEVICE IN QUESTION, HOW WAS THE PROCEDURE PERFORMED AND/OR FINISHED? ANOTHER NEEDLE. 12. WAS THE DEVICE DAMAGED IN PACKAGING PRIOR TO REMOVAL? NO. 13. WAS THE DEVICE DAMAGED ON REMOVAL FROM PACKAGING? NO. 14. WAS FORCE REQUIRED TO REMOVE THE DEVICE? NO. 15. DID THE PATIENT REQUIRE ANY ADDITIONAL PROCEDURES AS A RESULT OF THIS EVENT? NO. 16. WHAT INTERVENTION (IF ANY) WAS REQUIRED? 17. WAS THE SECONDARY INTERVENTION PERFORMED DURING THE SAME PROCEDURE AS THE DEVICE FAILURE OR WAS IT SCHEDULED FOR ANOTHER DAY? SAME PROCEDURE. 18. WERE ANY OTHER DEFECTS OBSERVED ON THE DEVICE PRIOR TO RETURN (E.G. KINKS, BENDS, BREAKS ETC.)? NO. 19. IF YES, PLEASE SPECIFY WHAT WAS OBSERVED AND WHERE ON THE DEVICE IT WAS OBSERVED. 20. WHAT IS THE SCOPE MANUFACTURER AND MODEL NUMBER THAT WAS USED? PENTAX 21. WAS RESISTANCE FELT WHILE INSERTING THE DEVICE THROUGH THE SCOPE? NO. 22. WAS THE SCOPE RECENTLY SERVICED / REPAIRED? N/A. 23. WHEN WAS THE ISSUED WITH THE PRODUCT NOTED? ON NEEDLE RETRACTION? 24. WAS THE SYRINGE USED DURING THE PROCEDURE, AFTER THE STYLET WAS REMOVED? YES. 25. WAS DIFFICULTY EXPERIENCED WHILE RETRACTING THE NEEDLE? NO. 26. WAS IT POSSIBLE TO FULLY RETRACT THE NEEDLE INTO THE SHEATH BEFORE REMOVING THE DEVICE FROM THE PATIENT? YES. 27. WAS THE ENDOSCOPE IN A FLEXED OR TWISTED POSITION AT ANY TIME DURING THE PROCEDURE? N/A. 28. WAS THE STYLET PARTIALLY REMOVED WHEN ADVANCING THE NEEDLE INTO THE TARGET SITE? YES. 29. HOW MANY SAMPLES WERE OBTAINED (PASSES COMPLETED) WITH THIS NEEDLE? 0. 30. DID ANY SECTION OF THE DEVICE DETACH INSIDE THE PATIENT? YES. IF YES, PLEASE SPECIFY: WHEN RETRACTING THE NEEDLE APPARENTLY, THE NEEDLE WAS BROKEN. 31. WAS THERE DIFFICULTY LOCKING THE SHEATH (OR NEEDLE) IN PLACE OR SLIPPING EXPERIENCED DURING USE? YES. 32. WAS THERE DIFFICULTY IN ATTACHING OR DETACHING THE DEVICE TO THE ACCESSORY CHANNEL PORT ON THE SCOPE? NO. 33. WHEN THE NEEDLE TIP WAS ADVANCED INTO THE TARGET SITE WAS THE DISTAL SCOPE POSITION ADJUSTED SO AS TO STRAIN OR FLEX THE NEEDLE? N/A, YES, NO -> TO BEEN SEEN WITH DOCTOR. 34. IF AN EBUS PROCEDURE DID THE NEEDLE TIP HIT THE CARTILAGE RINGS OF THE TRACHEA? N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    141019 ECHOTIP ULTRA ENDOSCOPIC ULTRASOUND NEEDLE FCG KIT, NEEDLE, BIOPSY FCG COOK IRELAND LTD C2002118 10827002315201

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention