BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SINGLE USE ASPIRATION NEEDLE

    MDR report key: 21793336 · Received April 7, 2025

    Report

    Report Number
    3011050570-2025-00333
    Event Type
    Malfunction
    Date Received
    April 7, 2025
    Date of Event
    February 24, 2025
    Report Date
    June 16, 2025
    Manufacturer
    GYRUS ACMI, INC.
    Product Code
    KTI
    PMA / PMN Number
    K163469
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION AND CORRECTION. THE DEVICE WAS RETURNED TO OLYMPUS FOR INSPECTION AND THE REPORTED FAILURE FOUND DURING INVESTIGATION WAS CONFIRMED. ACCORDING TO THE INVESTIGATION, THE PEBAX HEAT SHRINK WAS DAMAGED BY A BUCKLED FLEX SPIRAL CUT FROM THE NEEDLE. THE ROOT CAUSE COULD NOT BE IDENTIFIED. BASED ON THE RESULTS OF THE INVESTIGATION, INCORRECT ALIGNMENT BETWEEN NEEDLE DEVICES AND BIOPSY VALVE OR INCORRECT ALIGNMENT OF BIOPSY VALVE TO SCOPE AND NEEDLE BUCKLED AS A RESULT OF VERY HARD TISSUE OR DULL NEEDLE. THE INVESTIGATION COULD NOT CONCLUSIVELY SPECIFY THE ROOT CAUSE OF THE REPORTED ISSUE . ACCORDING TO THE INVESTIGATION, THE REPORTED ISSUE IS DETECTABLE AND PREVENTABLE: IF THE USER FEELS EXCESSIVE RESISTANCE WHILE OPERATING THE NEEDLE, DO NOT PUSH THE NEEDLE SLIDER FORCIBLY. DOING SO COULD CAUSE PATIENT INJURY, SUCH AS PERFORATION, BLEEDING, OR MUCOUS MEMBRANE DAMAGE. IT COULD ALSO DAMAGE THE INSTRUMENT AND/OR ENDOSCOPE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE ASPIRATION NEEDLE HAD A LEAKAGE OCCURRED 2 CM ABOVE THE TIP, AS IF THE NEEDLE WAS BROKEN. THE ISSUE OCCURRED DURING A THERAPEUTIC ENDOBRONCHIAL ULTRASOUND-GUIDED FINE NEEDLE ASPIRATION PROCEDURE. THE PROCEDURE WAS COMPLETED WITH AN OLYMPUS BACKUP DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    559140 SINGLE USE ASPIRATION NEEDLE VIZISHOT 2 FLEX KTI GYRUS ACMI, INC. NA-U403SX-4019 KR442734

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown