BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SINGLE USE ASPIRATION NEEDLE

    MDR report key: 19437488 · Received May 31, 2024

    Report

    Report Number
    3011050570-2024-10144
    Event Type
    Malfunction
    Date Received
    May 31, 2024
    Report Date
    June 12, 2024
    Manufacturer
    AOMORI OLYMPUS CO., LTD.
    Product Code
    FCG
    UDI-DI
    04953170389917
    PMA / PMN Number
    K050503
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE EVALUATION OF THE EVENT IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO INFORM/ PROVIDE A CORRECTION TO THE REGISTERED SITE, REPORT REFERENCE NUMBER, D2B, D3, D4 (PRODUCT MODEL), H6 OF THE INITIAL MDR REPORT SUBMITTED. THE CORRECT MODEL NUMBER IS BEING CORRECTED FROM NA-U403SX-4019 TO NA-201SX-4021. THE CORRECT REGISTERED SITE IS 9614641, NOT 3011050570. THE REGISTERED SITE AND LEGAL MANUFACTURING ADDRESS IS BEING CORRECTED FROM GYRUS ACMI, INC. TO AOMORI OLYMPUS CO. LTD., 2-248-1 OKKONOKI, KUROISHI-SHI, AOMORI, 036-0357, JAPAN. THE PROCODE IS BEING CORRECTED FROM KTI TO FCG. AWARE DATE IS BEING CORRECTED FROM 05/13/24 TO 05/08/24 FROM THE INITIAL MDR SUBMITTED. THE UDI IS BEING CORRECTED FROM (B)(4). THE MEDICAL DEVICE PROBLEM CODE IS BEING CORRECTED FROM A150207 DIFFICULT TO REMOVE TO A0510 RETRACTION PROBLEM.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT TWO SINGLE USE ASPIRATION NEEDLES WERE OPENED AND UNABLE TO BE USED DUE TO THE DEPTHS OF THE NEEDLE COMING OUT TOO FAR. THE ISSUE OCCURRED DURING PREPARATION FOR AN ENDOBRONCHIAL ULTRASOUND, PRIOR TO THE PATIENT BEING IN THE ROOM. THE PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308228 SINGLE USE ASPIRATION NEEDLE SINGLE USE ASPIRATION NEEDLE FCG AOMORI OLYMPUS CO., LTD. NA-201SX-4021 3YV 04953170389917
    864002 SINGLE USE ASPIRATION NEEDLE SINGLE USE ASPIRATION NEEDLE FCG AOMORI OLYMPUS CO., LTD. NA-201SX-4021 3YV 04953170389917

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown