BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECHOTIP ULTRA ENDOBRONCHIAL HD ULTRASOUND NEEDLE

    MDR report key: 12431667 · Received September 7, 2021

    Report

    Report Number
    3001845648-2021-00651
    Event Type
    Injury
    Date Received
    September 7, 2021
    Date of Event
    June 25, 2021
    Report Date
    October 6, 2021
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FCG
    UDI-DI
    10827002534084
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    510(K)#: K160229 THIS REPORT IS BEING SUBMITTED AS A CANCELLATION REPORT FOLLOWING CONCLUSION OF INVESTIGATION ON THE 27-OCT-2021.

    Description of Event or Problem · 0

    COMPLAINT DEVICE WAS RETURNED AND EVALUATED ON 06-OCT-2021, PROXIMAL KINK NOTED BELOW SHEATH EXTENDER. THIS REPORT IS BEING SUBMITTED AS A CANCELLATION REPORT FOLLOWING CONCLUSION OF INVESTIGATION ON THE 27-OCT-2021.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    DEFECTIVE NEEDLE WAS FOUND DURING THE PROCEDURE WHICH RESULTED IN THE DELAY OF THE PROCEDURE AND TO USE ANOTHER NEEDLE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID REQUIRE ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. AS PER CC FORM: "A NEW EBUS PROCEDURE WAS PERFORMED WITH A NEW EBUS NEEDLE." ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. CONSERVATIVE SERIOUS INJURY ASSIGNED BASED ON THE REPORT OF AN ADDITIONAL PROCEDURE - ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1330570 ECHOTIP ULTRA ENDOBRONCHIAL HD ULTRASOUND NEEDLE FCG KIT, NEEDLE, BIOPSY FCG COOK IRELAND LTD C1807792 10827002534084

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention