BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHOTIP PROCORE HIGH DEFINITION ULTRASOUND BIOPSY NEEDLE

    MDR report key: 20975537 · Received December 19, 2024

    Report

    Report Number
    3001845648-2024-00852
    Event Type
    Malfunction
    Date Received
    December 19, 2024
    Date of Event
    November 25, 2024
    Report Date
    April 23, 2026
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FCG
    UDI-DI
    10827002347851
    PMA / PMN Number
    K210476
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KR
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: THE DEVICE EVALUATION OF THE ECHO-HD-3-20-C DEVICE COULD NOT BE COMPLETED AS THE DEVICE OR PHOTOGRAPHIC EVIDENCE OF THE DEVICE WAS NOT RETURNED FOR EVALUATION. MANUFACTURING RECORDS: PRIOR TO DISTRIBUTION, ALL ECHO-HD-3-20-C DEVICES ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL INSPECTION TO ENSURE DEVICE INTEGRITY. A REVIEW OF THE MANUFACTURING RECORDS FOR ECHO-HD-3-20-C OF LOT NUMBER C2200376 DID 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 PREVIOUSLY OCCURRED FOR THIS WORK ORDER (B)(4). THIS WAS WITH CN-061940 WHICH WAS FROM THE SAME CUSTOMER. THE ROOT CAUSE FOR THIS COMPLAINT WAS AS FOLLOWS ¿DEVICE 1: THE EXACT ROOT CAUSE OF THE CUSTOMER COMPLAINT COULD NOT BE DETERMINED, AS THE CIRCUMSTANCES OF USE COULD NOT BE REPLICATED IN THE LABORATORY. HOWEVER, A POSSIBLE CAUSE MAY BE THAT THE MLLA WAS DAMAGED DURING SETUP OR THE PROCEDURE, LEADING TO DIFFICULTY IN DEVICE REMOVAL. THE CUSTOMER CONFIRMED THAT WHEN THE NURSE ATTEMPTED TO RETRACT THE NEEDLE FROM THE SCOPE CHANNEL, THE NEEDLE AND SHEATH SEPARATED INTO TWO PIECES. DEVICE 2: THE DEFINITIVE ROOT CAUSE OF THE COMPLAINT COULD NOT BE IDENTIFIED SINCE THE CONDITIONS OF USE COULD NOT BE REPLICATED IN THE LABORATORY. HOWEVER, THE CUSTOMER REPORTED EXPERIENCING THE SAME NEEDLE REMOVAL ISSUE WITH DEVICE 2. THE KINK BELOW THE SHEATH EXTENDER IS LIKELY ASSOCIATED WITH THE DIFFICULTY IN REMOVING THE NEEDLE.¿. BASED ON THE INFORMATION AVAILABLE TO DATE, THERE IS NO EVIDENCE TO SUGGEST THAT THERE ARE ANY MANUFACTURING ISSUES ASSOCIATED WITH LOT NUMBER. INSTRUCTIONS FOR USE AND/LABEL: THE NOTES SECTION OF THE INSTRUCTIONS FOR USE (IFU0077), WHICH ACCOMPANIES THIS DEVICE INSTRUCTS THE USER TO INSPECT THE DEVICE PRIOR TO USE: "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 (IFU0077). 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. HOWEVER, A POSSIBLE ROOT CAUSE MAY BE THAT THE MLLA WAS DAMAGED DURING SETUP OR THE PROCEDURE, LEADING TO DIFFICULTY IN REMOVING THE DEVICE. QUESTION 25 OF THE ADDITIONAL INFORMATION INDICATES THAT THERE WERE ISSUES ATTACHING OR DETACHING THE DEVICE FROM THE LEUR LOCK ON THE SCOPE. THE PROXIMAL KINK MENTIONED IN QUESTION 1 OF THE ADDITIONAL INFORMATION CAN BE LINKED WITH DIFFICULTY IN REMOVING THE NEEDLE. THE CUSTOMER CONFIRMED THAT WHEN THE NURSE ATTEMPTED TO WITHDRAW THE NEEDLE FROM THE SCOPE CHANNEL, A SMALL PIECE OF THE LEUR LOCK (ON THE PHYSICIAN¿S END) BROKE OFF. SUMMARY: ACCORDING TO THE CUSTOMER, NEEDLE COULDN'T BE LOOSEN. CONFIRMED QUANTITY OF (B)(4) DEVICE, CONFIRMED USED. COMPLAINT IS CONFIRMED BASED ON THE CUSTOMER AND OR REP TESTIMONY. ACCORDING TO THE INITIAL REPORT, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. INVESTIGATION FINDINGS CONCLUDE A DEFINITIVE ROOT CAUSE FOR THE CUSTOMER COMPLAINT COULD NOT BE DETERMINED AS CIRCUMSTANCES OF USE CANNOT BE REPLICATED IN THE LABORATORY. HOWEVER, A POSSIBLE ROOT CAUSE MAY BE THAT THE MLLA WAS DAMAGED DURING SETUP OR THE PROCEDURE, LEADING TO DIFFICULTY IN REMOVING THE DEVICE. QUESTION 25 OF THE ADDITIONAL INFORMATION INDICATES THAT THERE WERE ISSUES ATTACHING OR DETACHING THE DEVICE FROM THE LEUR LOCK ON THE SCOPE. THE PROXIMAL KINK MENTIONED IN QUESTION 1 OF THE ADDITIONAL INFORMATION CAN BE LINKED WITH DIFFICULTY IN REMOVING THE NEEDLE. THE CUSTOMER CONFIRMED THAT WHEN THE NURSE ATTEMPTED TO WITHDRAW THE NEEDLE FROM THE SCOPE CHANNEL, A SMALL PIECE OF THE LEUR LOCK (ON THE PHYSICIAN¿S END) BROKE OFF. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR SIMILAR EVENTS.

    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

    SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON 19 JUN 2025.

    Description of Event or Problem · 0

    THE PHYSICIAN TRIED TO DO FNB PROCEDURE, HE DID 1ST SESSION AND TRIED TO WITHDRAW THE NEEDLE OUT OF THE SCOPE. BUT THE NEEDLE (LUER LOCK) COULDN T BE LOOSENED. THE NURSE TRIED TO LOCK DOWN BUT IT WAS REALLY TIGHT. THEY REMOVED THE NEEDLE AND CASE FINISHED. 1. 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)? 2. PLEASE DESCRIBE THE LOCATION IN THE BODY FOR THE INTENDED TARGET SITE (PANCREAS, STOMACH, LUNGS ETC.). PANCREAS. A. IF THE LUNGS, WHICH LYMPH NODE WAS BEING TARGETED? E.G. 2R, 2L, 4R, AO, AR, 11RI, 11S ETC. PLEASE DESCRIBE THE SIZE OF THE INTENDED TARGET SITE. 1.5CM. 3. IF NOT WITH THE DEVICE IN QUESTION, HOW WAS THE PROCEDURE PERFORMED AND/OR FINISHED? THE PHYSICIAN STOPPED AT 1ST SESSION. 5. WAS THE DEVICE USED IN A TORTUOUS POSITION? NO 6. ARE IMAGES OF THE DEVICE OR PROCEDURE AVAILABLE? NO 7. WAS THE DEVICE DAMAGED IN PACKAGING BEFORE REMOVAL? NURSE ALREADY CHECKED. 8. WAS THE DEVICE DAMAGED ON REMOVAL FROM PACKAGING? NO 9. WAS FORCE REQUIRED TO REMOVE THE DEVICE? NO FOR COMPLAINTS OCCURRING DURING USE (ONCE IN CONTACT WITH ENDOSCOPE) ALSO ASK: 10. WHAT IS THE ENDOSCOPE MANUFACTURER AND MODEL NUMBER THAT WAS USED? OLYMPUS, GF-UCT-180. 11. WAS THE SCOPE RECENTLY SERVICED / REPAIRED? NO 12. WAS RESISTANCE FELT WHILE INSERTING THE DEVICE THROUGH THE SCOPE? NO 13. WHEN WAS THE ISSUED NOTED? E.G. ON ADVANCEMENT OF THE SHEATH/NEEDLE OR ON NEEDLE RETRACTION? DURING THE PROCEDURE. 14. WAS THE SYRINGE USED DURING THE PROCEDURE, AFTER THE STYLET WAS REMOVED? NO 15. WAS DIFFICULTY EXPERIENCED WHILE RETRACTING THE NEEDLE? NO 16. WAS IT POSSIBLE TO FULLY RETRACT BEFORE REMOVING THE NEEDLE FROM THE PATIENT? YES 17. WAS GAINING ACCESS TO THE TARGET SITE DIFFICULT? NO 18. WAS THE ENDOSCOPE IN A FLEXED OR TWISTED POSITION AT ANY TIME DURING THE PROCEDURE? NO 19. WAS PUNCTURE OF THE TARGET SITE DIFFICULT? YES 20. WAS THE STYLET PARTIALLY REMOVED WHEN ADVANCING INTO THE TARGET SITE?NO 21. HOW MANY SAMPLES WERE OBTAINED WITH THIS NEEDLE? 1 SAMPLE WAS OBTAINED. 22. DID ANY SECTION OF THE DEVICE DETACH INSIDE THE PATIENT? NO 23. IF THE DEVICE WAS KINKED BELOW THE SHEATH EXTENDER, WAS THE KINK OBSERVED BEFORE INSERTING THE DEVICE INTO THE SCOPE? N/A 24. WAS THERE DIFFICULTY LOCKING THE SHEATH (OR NEEDLE) IN PLACE OR SLIPPING EXPERIENCED DURING USE?NO 25. WAS THERE DIFFICULTY IN ATTACHING OR DETACHING THE DEVICE OF THE LEUR LOCK TO THE SCOPE? YES 26. IF THE DEVICE IS A PROCORE, IS THE KINK LOCATED DISTALLY AT THE NOTCH / CORE TRAP?NO

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    414517 ECHOTIP PROCORE HIGH DEFINITION ULTRASOUND BIOPSY NEEDLE FCG BIOPSY NEEDLE FCG COOK IRELAND LTD G34785 C2200376 10827002347851

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown