BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECHOTIP ULTRA ENDOBRONCHIAL HD ULTRASOUND NEEDLE

    MDR report key: 14166805 · Received April 21, 2022

    Report

    Report Number
    3001845648-2022-00238
    Event Type
    Injury
    Date Received
    April 21, 2022
    Date of Event
    March 10, 2022
    Report Date
    May 16, 2022
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FCG
    UDI-DI
    10827002520117
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    PMA/510(K) # K160229. INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.

    Additional Manufacturer Narrative · 0

    PMA/510(K) # K160229. DEVICE EVALUATION: COMPLAINT DEVICE WAS NOT RETURNED THEREFORE A DOCUMENT BASED REVIEW WILL BE PERFORMED. DOCUMENT REVIEW INCLUDING IFU REVIEW: PRIOR TO DISTRIBUTION, ALL ECHO-HD-22-EBUS-O DEVICES ARE SUBJECTED TO FUNCTIONAL CHECKS AND VISUAL INSPECTION TO ENSURE DEVICE INTEGRITY. A REVIEW OF THE MANUFACTURING RECORDS FOR ECHO-HD-22-EBUS-O OF LOT NUMBER C1892766 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 C1892766. THE NOTES SECTION OF THE INSTRUCTIONS FOR USE, IFU0051-8, WHICH ACCOMPANIES THIS DEVICE INSTRUCTS THE USER TO INSPECT THE DEVICE PRIOR TO USE: "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 (IFU0051-8). ROOT CAUSE REVIEW: A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. AS THERE WAS NO ADDITIONAL INFORMATION SHARED A POSSIBLE ROOT CAUSE IS DIFFICULT TO DETERMINE BUT COULD BE ATTRIBUTED TO ADVANCEMENT INTO A HARD LESION OR THROUGH HARD TISSUE SUCH AS CARTILAGE CAUSING THE DISTAL TIP OF THE NEEDLE TO BREAK. IT COULD ALSO BE DUE TORTUOUS ANATOMY REQUIRING FLEXED ENDOSCOPE POSITION AND EXTREME ANGULATION RESULTING IN THE DISTAL PART OF THE NEEDLE BREAKING. SUMMARY: COMPLAINT IS CONFIRMED BASED ON CUSTOMER¿S TESTIMONY. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID EXPERIENCE ADVERSE EFFECTS DUE TO THIS OCCURRENCE AS MINIMAL BLEEDING AND COUGHING WAS REPORTED. IT WAS CONFIRMED THAT THE BROKEN NEEDLE PART WAS COUGHED OUT BY THE PATIENT. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 0

    AS REPORTED TO CUSTOMER RELATIONS VIA PHONE CONVERSATION "THE PHYSICIAN RETRACTED THE SCOPE AND NOTICED THE NEEDLE HAD BROKEN-OFF. THE PHYSICIAN WENT BACK-IN AND COULD NOT FIND THE BROKEN PIECE. THE PATIENT ACTUALLY COUGHED-OUT THE BROKEN PORTION OF THE NEEDLE (WHILE THE PATIENT WAS IN THE RECOVERY AREA - AFTER EXTUBATION / PULLING THE AIR WAY OUT)". NOTE: REMOVAL OF THE NEEDLE THROUGH THE SCOPE MET RESISTANCE. THE PHYSICIAN IS REQUESTING WHAT TYPE OF METAL THE NEEDLE IS MADE OF. I CONTACTED THE DM (VIA PHONE CONVERSATION) AND PROVIDE HIM WITH THE CUSTOMER'S CONTACT INFO. HE STATED HE WILL FOLLOW UP WITH THE CUSTOMER ACCORDINGLY TO ANSWER THEIR QUESTIONS. DID ANY UNINTENDED SECTION OF THE DEVICE REMAIN INSIDE THE PATIENT¿S BODY? NOT THE CUSTOMER IS AWARE OF (HOWEVER IT IS POSSIBLE AS THERE COULD BE A POTENTIAL FRAGMENT STILL REMAINING). PLEASE DESCRIBE THE OBJECT AND HOW IT WAS RETRIEVED: DID THE PATIENT EXPERIENCE A DELAY OR REQUIRE ANY ADDITIONAL PROCEDURE DUE TO THIS OCCURRENCE? NO. PLEASE SPECIFY DELAY OR ANY ADDITIONAL PROCEDURE(S) AND PROVIDE DETAILS: HAS THE COMPLAINANT REPORTED ANY ADVERSE EFFECTS ON THE PATIENT DUE TO THIS OCCURRENCE? MINIMAL BLEEDING AND COUGHING. HAS THE COMPLAINANT REPORTED THAT THE PRODUCT CAUSED OR CONTRIBUTED TO THE ADVERSE EFFECTS? YES. PLEASE SPECIFY ADVERSE EFFECTS AND PROVIDE DETAILS.

    Description of Event or Problem · 0

    SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1920336 ECHOTIP ULTRA ENDOBRONCHIAL HD ULTRASOUND NEEDLE FCG KIT, NEEDLE, BIOPSY FCG COOK IRELAND LTD C1892766 10827002520117

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Male Required Intervention