BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SINGLE USE BIOPSY VALVE (STERILE)

    MDR report key: 23942809 · Received January 2, 2026

    Report

    Report Number
    3003637092-2026-00001
    Event Type
    Injury
    Date Received
    January 2, 2026
    Date of Event
    December 12, 2025
    Report Date
    February 4, 2026
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP. HINODE PLANT
    Product Code
    EOQ
    UDI-DI
    14953170152433
    PMA / PMN Number
    K061313
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE RESULTS OF THE FINAL INVESTIGATION AND ADDITIONAL INFORMATION: H4. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. THE DEVICE WAS RETURNED TO OLYMPUS FOR INSPECTION AND THE REPORTED FAILURE WAS CONFIRMED. BASED ON THE RESULTS OF THE INVESTIGATION, IT IS LIKELY THE FOLLOWING LED TO THE MALFUNCTION: THE SLIT PORTION CHIPPED OFF AND DETACHED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    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.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A THERAPEUTIC ENDOBRONCHIAL ULTRASOUND WITH A GUIDE SHEATH TRANSBRONCHIAL (EBUS-GS) A FOREIGN MATERIAL, BELIEVED TO BE A PART OF THE BIOPSY VALVE, FELL OFF INTO THE LUNG. THE FOREIGN MATERIAL MEASURING APPROXIMATELY 1MM × 1.5MM.WAS REMOVED BY FORCEPS. THERE WAS AN APPROXIMATELY 10 MINUTE DELAY. THE DEVICE WAS REPLACED AND THE PROCEDURE WAS COMPLETED. THERE WAS NO HARM OR INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    3458 SINGLE USE BIOPSY VALVE (STERILE) SINGLE USE BIOPSY VALVE EOQ OLYMPUS MEDICAL SYSTEMS CORP. HINODE PLANT MAJ-210 H5517 14953170152433

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention BF-Q290 SN: (B)(6) | K-201 LOT UNK| UM-S20-17S LOT UNK