BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECHOTIP ULTRA ENDOBRONCHIAL HD ULTRASOUND NEEDLE

    MDR report key: 15769625 · Received November 10, 2022

    Report

    Report Number
    3001845648-2022-00761
    Event Type
    Injury
    Date Received
    November 10, 2022
    Date of Event
    October 11, 2022
    Report Date
    November 23, 2022
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FCG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    PMA 510K # K210476. DEVICE EVALUATION: 1 UNIT OF LOT C1964887 OF ECHO-HD-22-EBUS-P WAS RETURNED OPENED AND INCORRECTLY PACKED IN THE ORIGINAL PACKAGING OF RELATED COMPLAINT. LAB EVALUATION: THE DEVICE RELATED TO THIS OCCURRENCE UNDERWENT A LABORATORY EVALUATION ON (B)(6). THE BROKEN NEEDLE TIP OF APPROX. 1.5CM IN LENGTH WAS RETURNED SEPARATELY TO THE DEVICE. THE NEEDLE WAS ABLE TO ADVANCE AND RETRACT WITHOUT ANY ISSUE. DOCUMENT REVIEW INCLUDING IFU REVIEW: PRIOR TO DISTRIBUTION, ALL ECHO-HD-22-EBUS-P 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-P OF LOT NUMBER C1964887 DID NOT REVEAL ANY DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT ISSUE. 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 C1964887. THE NOTES SECTION OF THE INSTRUCTIONS FOR USE, IFU0060-5 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 TARGET SITE". THERE IS EVIDENCE TO SUGGEST THAT THE CUSTOMER DID NOT FOLLOW THE INSTRUCTIONS FOR USE IN RELATION TO THE USE OF THE STYLET (IFU0060-5). IMAGE REVIEW: N/A. ROOT CAUSE REVIEW: 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. 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. THE BROKEN NEEDLE TIP WAS RECOVERED FROM THE PATIENT USING A FORCEPS. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 0

    CUST. CALLED TO REPORT THAT TWO NEEDLES HAD BEEN BENDING. USER COULDN'T RETRACT IT FROM THE PLASTIC BODY USED ON PATIENT BUT NO HARM. USED OTHER NEEDLES WHICH WORKED THEN. AS PER COMPLAINT FORM: ONE NEEDLE BROKE WITHIN PATIENT, SUCCESSFULLY REMOVED PIECE WITH FORCEPS. (PR (B)(4) - CURRENT FILE) SECOND NEEDLE COULD NOT BE PULLED BACK INTO SHEATH FOR REMOVAL (PR (B)(4)). A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. END OF NEEDLE WAS RETRIEVED. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Description of Event or Problem · 0

    SUPPLEMENTAL FOLLOW-UP REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION AND AN UPDATE TO THE INVESTIGATION CONCLUSIONS ON THE 23-NOV-2022.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    458440 ECHOTIP ULTRA ENDOBRONCHIAL HD ULTRASOUND NEEDLE FCG KIT, NEEDLE, BIOPSY FCG COOK IRELAND LTD C1964887

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention