BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECHOTIP ULTRA ENDOBRONCHIAL HD ULTRASOUND NEEDLE

    MDR report key: 17049001 · Received June 2, 2023

    Report

    Report Number
    3001845648-2023-00433
    Event Type
    Injury
    Date Received
    June 2, 2023
    Report Date
    August 21, 2023
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FCG
    UDI-DI
    10827002240626
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PMA510K #K210476. DEVICE EVALUATION: THE DEVICE EVALUATION 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-25-EBUS-O DEVICES ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL INSPECTION TO ENSURE DEVICE INTEGRITY. A REVIEW OF THE MANUFACTURING RECORDS FOR ECHO-HD-25-EBUS-O OF LOT NUMBER C1988342 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 NOT PREVIOUSLY OCCURRED FOR THIS WORK ORDER. INSTRUCTIONS FOR USE AND/LABEL: THE NOTES SECTION OF THE INSTRUCTIONS FOR USE, IFU0051 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¿. THERE IS NO EVIDENCE TO SUGGEST THAT THE CUSTOMER DID NOT FOLLOW THE INSTRUCTIONS FOR USE (IFU0051). IMAGE REVIEW: AN IMAGE WAS NOT RETURNED FOR EVALUATION. ROOT CAUSE ANALYSIS: A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. AS NO DEVICE WAS RETURNED AND NO ADDITIONAL INFORMATION WAS SHARED A POSSIBLE ROOT CAUSE IS DIFFICULT TO DETERMINE BUT COULD BE ATTRIBUTED TO ADVANCEMENT INTO A HARD LESION OR THROUGH HARD TISSUE CAUSING THE DISTAL END OF THE NEEDLE TO BREAK. SUMMARY: COMPLAINT IS CONFIRMED BASED ON CUSTOMER AND/OR REP TESTIMONY. NO PATIENT OUTCOME INFORMATION WAS SHARED. THE BROKEN NEEDLE TIP WAS REMOVED FROM THE PATIENT AND AN X-RAY WAS COMPLETED. 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 REPORT WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.

    Description of Event or Problem · 0

    SUPPLEMENT REPORT BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON (B)(6) 2023.

    Description of Event or Problem · 0

    DEVICE FAILED IN USE TIP BROKE OFF APPROXIMATELY 25MM FROM THE END. THE TIP WAS REMOVED FROM THE PATIENT AND THE PATIENT X-RAYED TO ENSURE EVERYTHING HAD BEEN RETRIEVED. THIS RESULTED IN THE PATIENT RECEIVING A DOSE OF X-RAY THE WOULD NOT NORMALLY HAVE RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1649235 ECHOTIP ULTRA ENDOBRONCHIAL HD ULTRASOUND NEEDLE FCG KIT, NEEDLE, BIOPSY FCG COOK IRELAND LTD C1988342 10827002240626

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention