BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECHOTIP ULTRA ENDOBRONCHIAL HD ULTRASOUND NEEDLE

    MDR report key: 9848023 · Received March 18, 2020

    Report

    Report Number
    3001845648-2020-00158
    Event Type
    Injury
    Date Received
    March 18, 2020
    Date of Event
    February 17, 2020
    Report Date
    April 27, 2020
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FCG
    UDI-DI
    10827002520117
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    PMA/510(K) #K160229. 1 UNIT OF LOT C1665756 OF ECHO-HD-22-EBUS-O WAS RETURNED OPENED IN ITS ORIGINAL PACKAGING. THE DEVICE INVOLVED IN THE COMPLAINT WAS EVALUATED IN THE LABORATORY. THE NEEDLE WAS FOUND TO BE BROKEN DISTALLY. PRIOR TO DISTRIBUTION, ALL ECHO-HD-22-EBUS-O DEVICES ARE SUBJECTED TO FUNCTIONAL CHECKS AND VISUAL INSPECTION TO ENSURE DEVICE INTEGRITY. THESE INSPECTIONS AND FUNCTIONAL CHECKS ARE OUTLINED IN INTERNAL PROCEDURES IN PLACE AT CIRL. A REVIEW OF THE MANUFACTURING RECORDS FOR ECHO-HD-22-EBUS-O OF LOT NUMBER C1665756 DID NOT REVEAL ANY DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT ISSUE. THE REVIEW OF RELEVANT MANUFACTURING RECORDS, CONFIRMS THE FAILURE MODE HAS 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 C1665756. THE NOTES SECTION OF THE INSTRUCTIONS FOR USE, 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 "ENSURE THE STYLET IS FULLY INSERTED WHEN ADVANCING THE NEEDLE INTO THE BIOPSY SITE" 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 USE OF THE STYLET. Q.10 OF THE ADDITIONAL INFORMATION ALSO INDICATES THAT A FUJI SCOPE WAS USED RATHER THAN AN OLYMPUS SCOPE AS PER IFU0051-8¿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 A DEFINITIVE ROOT CAUSE COULD BE ATTRIBUTED TO USER ERROR AS THE STYLET SHOULD NOT BE PARTIALLY REMOVED PRIOR TO ADVANCEMENT OF THE NEEDLE INTO INTENDED TARGETED SITE. AS THE STYLET PROVIDES SUPPORT TO THE NEEDLE FOR PUNCTURE THIS WOULD HAVE LED TO THE DISTAL END OF THE NEEDLE TO BREAK. COMPLAINT IS CONFIRMED AS THE FAILURE WAS VERIFIED IN THE LABORATORY AND IMAGES PROVIDED. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. PROBABLY PATIENT WILL PERFORM OPEN SURGERY CASE BY A DOCTOR TO GETTING BACK BROKEN PART FROM THE TISSUE. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 0

    ON EBUS CASE, DR. (B)(6) HAS BEEN PUNCHED THE NEEDLE THEN THEY STARTED TO GETTING SAMPLE. AFTER THE ASPIRATION, THEY REALIZED THAT NEEDLE TIP (APROX 6MM PART) HAS BEEN BROKEN AND THE BROKEN PART HAS BEEN STAYED INTO TISSUE. A SECTION OF THE DEVICE DID REMAIN INSIDE THE PATIENT¿S BODY. BROKEN PART STAYED OVER THE TISSUE. NEEDLE TIP (APROX 6MM PART) HAS BEEN BROKEN AND THE BROKEN PART HAS BEEN STAYED INTO TISSUE. BROKEN PART IS STILL INTO TISSUE THE PATIENT DID REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. BT IMAGING ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE .PROBABLY PATIENT WILL PERFORM OPEN SURGERY CASE BY A DOCTOR TO GETTING BACK BROKEN PART FROM THE TISSUE.

    Additional Manufacturer Narrative · 1

    510 K # : K160229. INVESTIGATION IS STILL PENDING. A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.

    Description of Event or Problem · 1

    ON EBUS CASE, DR. (B)(6) HAS BEEN PUNCHED THE NEEDLE THEN THEY STARTED TO GETTING SAMPLE. AFTER THE ASPIRATION, THEY REALIZED THAT NEEDLE TIP (APROX 6MM PART) HAS BEEN BROKEN AND THE BROKEN PART HAS BEEN STAYED INTO TISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310030 ECHOTIP ULTRA ENDOBRONCHIAL HD ULTRASOUND NEEDLE FCG KIT, NEEDLE, BIOPSY FCG COOK IRELAND LTD C1665756 10827002520117

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention