BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BALLOON OLYMPUS EBUS

    MDR report key: 20180376 · Received September 10, 2024

    Report

    Report Number
    20180376
    Event Type
    Malfunction
    Date Received
    September 10, 2024
    Date of Event
    February 27, 2024
    Report Date
    March 7, 2024
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FDS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    DURING BRONCHOSCOPY-EBUS (ENDOBRONCHIAL ULTRASOUND) PROCEDURE, THE BALLOONS WHICH WERE PLACED AT THE END OF THE BRONCHOSCOPE HAD TINY HOLES IN THEM. A TOTAL OF (B)(4) DEFECTIVE BALLOONS WERE DISCOVERED. EFFECTED THE DURATION OF THE PROCEDURE. MANUFACTURER RESPONSE FOR OLYMPUS EBUS-TBA ENDOSCOPE BALLOON MAJ-1351, OLYMPUS EBUS-TBA ENDOSCOPE BALLOON (PER SITE REPORTER). REP IS [NAME REDACTED], I CONTACTED ON [DATE REDACTED] VIA EMAIL. ENDOSCOPY ACCOUNT MANAGER GI&R, OLYMPUS AMERICA, INC, CELL: [REDACTED], EMAIL: [REDACTED].

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2330213 BALLOON OLYMPUS EBUS GASTROSCOPE AND ACCESSORIES, FLEXIBLE/RIGID FDS OLYMPUS MEDICAL SYSTEMS CORP. MAJ-1351 3XK

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Male