BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHOTIP ULTRA ENDOBRONCHIAL HD ULTRASOUND NEEDLE

    MDR report key: 15299911 · Received August 26, 2022

    Report

    Report Number
    3001845648-2022-00586
    Event Type
    Malfunction
    Date Received
    August 26, 2022
    Date of Event
    June 30, 2022
    Report Date
    September 8, 2022
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FCG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PMA/510(K) # K210476. INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.

    Additional Manufacturer Narrative · 0

    PMA/510(K) # K210476 SUPPLEMENTAL REPORT IS BEING SUBMITTED AS A CANCELLATION REPORT FOLLOWING CONFIRMATION RECEIVED ON 08-SEP-2022 THAT THE REPLACEMENT DEVICE WAS NOT USED IN THE ASSISTANCE OF EMBRYO REPRODUCTION

    Description of Event or Problem · 0

    BEFORE NEEDLE GOT USED ON PATIENT THE NURSE CHECKED IT AND FOUND THAT THE STYLET COULD NOT BE REMOVED VERY EASILY. THEY DID NOT USE THE NEEDLE AND USED A NEW NEEDLE ON THE PATIENT. REPLACEMENT DEVICE USED IN THE ASSISTANCE OF EMBRYO REPRODUCTION WHICH IS CONSIDERED OFF LABEL USE.

    Description of Event or Problem · 0

    SUPPLEMENTAL REPORT IS BEING SUBMITTED AS A CANCELLATION REPORT FOLLOWING CONFIRMATION RECEIVED ON (B)(6) 2022 THAT THE REPLACEMENT DEVICE WAS NOT USED IN THE ASSISTANCE OF EMBRYO REPRODUCTION

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    436999 ECHOTIP ULTRA ENDOBRONCHIAL HD ULTRASOUND NEEDLE FCG KIT, NEEDLE, BIOPSY FCG COOK IRELAND LTD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown