BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECHOTIP PROCORE ENDOBRONCHIAL HD BIOPSY NEEDLE

    MDR report key: 9240477 · Received October 25, 2019

    Report

    Report Number
    3005580113-2019-00632
    Event Type
    Injury
    Date Received
    October 25, 2019
    Date of Event
    October 3, 2019
    Report Date
    October 25, 2019
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FCG
    UDI-DI
    00827002342798
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    COMMON NAME: FCG KIT, NEEDLE, BIOPSY. PRODUCT CODE: FCG.

    Description of Event or Problem · 1

    PER DR. (B)(6) VIA EMAIL: THE NEEDLE BENT AT THE PATIENT END AND BROKE OFF WHEN THE SCOPE WAS WITHDRAWN. THERE WAS NO ISSUE ON VISUAL INSPECTION OF THE NEEDLE BEFOREHAND, AFTER THE PROCEDURE, THE END OF THE NEEDLE WAS NOT PRESENT. THE NEEDLE REMNANT ADVANCED THROUGH THE SHEATH WITHOUT ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1031682 ECHOTIP PROCORE ENDOBRONCHIAL HD BIOPSY NEEDLE FCG COOK IRELAND LTD G34279 C1631930 00827002342798

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention