BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECHOTIP PROCORE ENDOBRONCHIAL HD BIOPSY NEEDLE

    MDR report key: 20395834 · Received October 8, 2024

    Report

    Report Number
    3001845648-2024-00591
    Event Type
    Injury
    Date Received
    October 8, 2024
    Date of Event
    September 3, 2024
    Report Date
    January 7, 2025
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FCG
    UDI-DI
    10827002342818
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PMA/510(K) # K210476. SUPPLEMENTAL CORRECTION REPORT IS BEING SUBMITTED TO UPDATE THE ANNEX CODE A, FOLLOWING A REVIEW OF THIS COMPLAINT FILE ON (B)(6) 2024. ADDITIONAL INFORMATION RECEIVED ON 12-DEC-2024 ¿ ¿[ENGINEERING INPUT REQUEST TO SEPARATE THE FILES (B)(4) TO COVER DISTAL BREAK AND (B)(4). TO COVER USE ERROR].

    Additional Manufacturer Narrative · 0

    PMA/510(K) # K210476. DEVICE EVALUATION: THE DEVICE EVALUATION COULD NOT BE COMPLETED AS THE DEVICE OR PHOTOGRAPHIC EVIDENCE OF THE DEVICE WAS NOT RETURNED FOR EVALUATION. IT SHOULD BE NOTED THAT THIS FILE IS RELATED TO ANOTHER COMPLAINT FILE. FOR DETAILS OF THE OTHER INVESTIGATION PLEASE REFER TO (B)(4). THROUGH THE INVESTIGATION OF RELATED COMPLAINT (B)(4) IT WAS CONFIRMED THAT ANOTHER SIMILAR CASE HAD TAKEN PLACE ONE WEEK BEFORE WHICH WILL BE INVESTIGATED UNDER THIS FILE. THE LOT NUMBER OF THE DEVICE USED UNDER (B)(4) COULD NOT BE CONFIRMED. NO ANSWERS TO THE STANDARD QUESTIONS WERE POSSIBLE TO OBTAIN. MANUFACTURING RECORDS: PRIOR TO DISTRIBUTION, ALL ECHO-HD-22-EBUS-O-C DEVICES ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL INSPECTION TO ENSURE DEVICE INTEGRITY. MANUFACTURING RECORDS REVIEW COULD NOT BE COMPLETED AS THE LOT NUMBER IS UNKNOWN. INSTRUCTIONS FOR USE AND/LABEL. THE NOTES SECTION OF THE INSTRUCTIONS FOR USE, IFU0109 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¿ AND "THIS DEVICE IS INTENDED FOR USE WITH AN OLYMPUS EBUS SCOPE". THERE IS EVIDENCE TO SUGGEST THAT THE CUSTOMER DID NOT FOLLOW THE INSTRUCTIONS FOR USE IN RELATION TO THE TYPE OF SCOPE USED (IFU0109). IMAGE REVIEW: AN IMAGE WAS NOT RETURNED FOR EVALUATION. ROOT CAUSE ANALYSIS: A DEFINITIVE ROOT CAUSE COULD BE ATTRIBUTED TO USER ERROR AS THE USER USED THE DEVICE WITH AN INCOMPATIBLE DEVICE, AS PER INFORMATION PROVIDED, A FUJI SCOPE WAS USED AND AS PER IFU ¿THIS DEVICE IS INTENDED FOR USE WITH AN OLYMPUS EBUS SCOPE¿, THEREFORE THE USER DID NOT FOLLOW THE INSTRUCTIONS FOR USE. IT IS NOT POSSIBLE TO KNOW HOW THE DEVICE PERFORMS WITH AN INCOMPATIBLE DEVICE THEREFORE THE NEEDLE TIP BREAK ENCOUNTERED BY THE USER COULD HAVE BEEN INDUCED BY THE SCOPE. SUMMARY: COMPLAINT IS CONFIRMED BASED ON CUSTOMER AND/OR REP TESTIMONY. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. AFTER GETTING OUT THE NEEDLE TIP WITH A FORCEPS, THE EBUS CASE WAS FINISHED WITH AN OLYMPUS NEEDLE. 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 CORRECTION REPORT IS BEING SUBMITTED TO UPDATE THE ANNEX CODE A, FOLLOWING A REVIEW OF THIS COMPLAINT FILE ON (B)(6) 2024.

    Description of Event or Problem · 0

    A SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO ADDITIONAL INFORMATION RECEIVED ON 07-JAN-2025 AND THE COMPLETION OF THE INVESTIGATION ON 14-JAN-2025. ADDITIONAL INFORMATION RECEIVED ON 07 JAN 2025 ¿ ENGINEERING CONFIRM BREAK RELATED TO USE ERROR OF INCORRECT SCOPE.

    Description of Event or Problem · 0

    REP WAS INFORMED THAT IN 2 CASES THE TIP OF THE NEEDLE BROKE OFF 1 PIECE AVAILABLE FOR EVALUATION THE OTHER WAS SCRAPPED. "AS PER CC FORM": DURING EBUS PROCEDURE NEEDLE TIP BROKE OFF AND WAS GET OUT OF THE LUNG WITH A FORCEPS (B)(4). (B)(4) IS GOING TO CAPTURE ONE CASE. A SECTION OF THE DEVICE DID REMAIN INSIDE THE PATIENT¿S BODY. NEEDLE TIP REMAIN IN THE LUNG BUT PUT OUT WITH A FORCEPS. THE PATIENT DID REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. AFTER GETTING OUT THE NEEDLE TIP WITH A FORCEPS, THE EBUS CASE WAS FINISHED WITH AN OLYMPUS NEEDLE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. THE CUSTOMER IS INFORMED ABOUT THE OFF-LABEL USE OF OUR NEEDLE WITH THE FUJI SCOPE. HE USES THIS COMBINATION OVER ONE YEAR AND NOW, HE HAD TWO CASES WITH BROKEN TIPS. BUT I CAN ONLY SEND ONE NEEDLE BACK THE OTHER ONE WAS THROWN AWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    246462 ECHOTIP PROCORE ENDOBRONCHIAL HD BIOPSY NEEDLE FCG KIT, NEEDLE, BIOPSY FCG COOK IRELAND LTD C2196651 10827002342818

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention