BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECHOTIP PROCORE ENDOBRONCHIAL HD BIOPSY NEEDLE

    MDR report key: 16909792 · Received May 11, 2023

    Report

    Report Number
    3001845648-2023-00340
    Event Type
    Injury
    Date Received
    May 11, 2023
    Report Date
    August 14, 2023
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FCG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    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 C1876065 OF ECHO-HD-25-EBUS-O-C WAS RETURNED OPENED IN ITS ORIGINAL PACKAGING. THE DEVICE RELATED TO THIS OCCURRENCE UNDERWENT A LABORATORY EVALUATION ON 29 JUNE 2023. THE BROKEN NEEDLE TIP OF APPROX. 1.6CM IN LENGTH WAS RETURNED SEPARATELY TO THE DEVICE. A PROXIMAL KINK BELOW THE SHEATH EXTENDER WAS ALSO OBSERVED. THROUGH THE INVESTIGATION IT WAS ESTABLISHED THAT THE PROXIMAL KINK WHICH WAS OBSERVED DURING THE LAB EVALUATION MOST LIKELY CAME ABOUT AS A RESULT OF THE TRANSPORT RETURNS PROCESS. MANUFACTURING RECORDS: PRIOR TO DISTRIBUTION, ALL ECHO-HD-25-EBUS-O-C 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-C OF LOT NUMBER C1876065 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, 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¿. THERE IS NO EVIDENCE TO SUGGEST THAT THE CUSTOMER DID NOT FOLLOW THE INSTRUCTIONS FOR USE (IFU0109) IMAGE REVIEW: AN IMAGE WAS NOT RETURNED FOR EVALUATION. ROOT CAUSE ANALYSIS: A DEFINITIVE ROOT CAUSE FOR THE CUSTOMER COMPLAINT COULD NOT BE DETERMINED AS CIRCUMSTANCES OF USE CANNOT BE REPLICATED IN THE LABORATORY. A POSSIBLE ROOT CAUSE COULD BE ATTRIBUTED TO DIFFICULT TARGET SITE AND THE DEVICE BEING USED IN A FLEXED POSITION AS INDICATED IN THE ADDITIONAL INFORMATION WHICH COULD HAVE CAUSED THE DISTAL END OF THE NEEDLE TO BREAK. ANOTHER POSSIBLE ROOT CAUSE COULD BE ATTRIBUTED TO THE NEEDLE TIP HITTING THE CARTILAGE RINGS OF THE TRACHEA AS PER ADDITIONAL INFORMATION LEADING TO THE DISTAL TIP OF THE NEEDLE TO BREAK. SUMMARY: COMPLAINT IS CONFIRMED BASED ON VISUAL AND/OR FUNCTIONAL INSPECTION. ACCORDING TO THE INITIAL REPORTER, THERE WAS NO DETAIL OF THE PATIENT EXPERIENCING ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. THE BROKEN NEEDLE TIP WAS FOUND IN THE PATIENT¿S MOUTH WHEN THE SCOPE WAS WITHDRAWN AT THE END OF THE PROCEDURE. 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

    SUPPLEMENT REPORT BEING SUBMITTED DUE TO THE COMPLETION OF THE LAB EVALUATION ON 29-JUNE-2023.

    Description of Event or Problem · 0

    SUPPLEMENT REPORT BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON THE 14-AUG-2023.

    Description of Event or Problem · 0

    NEEDLE BROKE OFF IN PATIENT DURING PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2190201 ECHOTIP PROCORE ENDOBRONCHIAL HD BIOPSY NEEDLE FCG KIT, NEEDLE, BIOPSY FCG COOK IRELAND LTD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention