BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECHOTIP ULTRA ENDOBRONCHIAL HD ULTRASOUND NEEDLE

    MDR report key: 14247820 · Received April 29, 2022

    Report

    Report Number
    3001845648-2022-00260
    Event Type
    Injury
    Date Received
    April 29, 2022
    Date of Event
    March 26, 2022
    Report Date
    May 10, 2022
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FCG
    UDI-DI
    10827002534084
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PMA/510(K) # K160229. THE INVESTIGATION IS IN PROGRESS AND A FOLLOW UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    PMA/510(K) # K160229. DEVICE EVALUATION: 1 UNIT OF LOT C1822917 OF ECHO-HD-22-EBUS-P WAS RETURNED OPENED IN ITS ORIGINAL PACKAGING. LAB EVALUATION: THE DEVICE RELATED TO THIS OCCURRENCE UNDERWENT A LABORATORY EVALUATION ON (B)(6) 2022. THE DISTAL END OF THE NEEDLE RETURNED WAS OBSERVED TO BE BROKEN APPROX. 3CM FROM THE TIP OF THE SHEATH. 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 C1822917 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 C1822917. THE NOTES SECTION OF THE INSTRUCTIONS FOR USE, IFU0060-5, WHICH ACCOMPANIES THIS DEVICE INSTRUCTS THE USER TO INSPECT THE DEVICE PRIOR TO USE FOR ANY DAMAGE: "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 (IFU0060-5). IMAGE REVIEW: N/A. 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. ALTHOUGH IT WAS ADVISED TARGET SITE WAS NOT DIFFICULT, IT IS POSSIBLE THE ACTUAL LESION WAS HARD LEADING TO THE DISTAL END OF THE NEEDLE TO BREAK DURING THE PUNCTURE ATTEMPT OF THE LYMPH NODE. ANOTHER POSSIBLE ROOT CAUSE COULD BE ATTRIBUTED TO THE NEEDLE HITTING OR PASSING HARD CARTILAGE LEADING TO THE DISTAL END OF THE NEEDLE TO BREAK AFTER THE PUNCTURE ATTEMPT. SUMMARY: COMPLAINT IS CONFIRMED AS THE FAILURE WAS VERIFIED IN THE LABORATORY. ACCORDING TO THE INITIAL REPORTER, THE BROKEN NEEDLE TIP WAS REMOVED WITH A RATH TOOTH FORCEP. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 0

    NEEDLE BROKE. WHEN DOCTOR TRIED TO PUNCTURE THE LYMPH NODE NEEDLE BROKE. TIP OF THE NEEDLE, REMOVED WITH RATH TOOTH FORCEP.

    Description of Event or Problem · 0

    SUPPLEMENTAL FOLLOW-UP REPORT IS BEING SUBMITTED DUE TO ADDITIONAL INFORMATION RECIEVED 10-MAY, DEVICE EVALUATION ON THE 25-MAY 2022 AND THE COMPLETION OF THE INVESTIGATION AND AN UPDATE TO THE INVESTIGATION CONCLUSIONS ON THE 02-JUN-2022.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    115283 ECHOTIP ULTRA ENDOBRONCHIAL HD ULTRASOUND NEEDLE FCG KIT, NEEDLE, BIOPSY FCG COOK IRELAND LTD C1822917 10827002534084

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male Required Intervention