BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SINGLE USE COMBINATION CLEANING BRUSH

    MDR report key: 22906075 · Received August 27, 2025

    Report

    Report Number
    9614641-2025-01441
    Event Type
    Malfunction
    Date Received
    August 27, 2025
    Date of Event
    August 1, 2025
    Report Date
    September 26, 2025
    Manufacturer
    AOMORI OLYMPUS CO., LTD.
    Product Code
    MNL
    UDI-DI
    04953170297427
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    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

    UPDATED FIELDS: H2, H3, H6, AND H11. THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE RESULTS OF THE FINAL INVESTIGATION. THE DEVICE WAS NOT RETURNED TO OLYMPUS FOR INSPECTION AND THE REPORTED FAILURE WAS NOT CONFIRMED. BASED ON THE RESULTS OF THE INVESTIGATION, AND SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION, THE DEFINITIVE ROOT CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED. 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 DURING REPROCESSING, NURSE FOUND BRUSH STUCK IN BIOPSY CHANNEL. THERE WERE NO REPORT OF PATIENT INVOLVEMENT. ----------------------------------------------- 05-AUG-2025, WE RECEIVED FOLLOWING INFORMATION FROM DD-122862: 1. WITH REFERENCE TO THE EVENT DESCRIPTION MENTIONS ANOTHER DEVICE, THE ¿BRUSH STUCK IN BIOPSY CHANNEL¿ COULD YOU KINDLY CONFIRM WHETHER THE BRUSH IS AN OLYMPUS PRODUCT? IF YES, WE WOULD APPRECIATE IT IF YOU COULD PROVIDE THE PRODUCT MODEL, SERIAL NUMBER, AND ITEM CODE FOR OUR REFERENCE. ANSWER: OLYMPUS, BW-412T. 2. COULD YOU PLEASE KINDLY CONFIRM WAS THERE ANY MALFUNCTION OF PRODUCT ¿BRUSH¿? ANSWER: BRUSH SEPARATE FROM THE BODY AND STRUCT INSIDE THE SCOPE. 3. COULD YOU PLEASE KINDLY CONFIRM WHETHER THE PRODUCT REFERRED TO AS ¿BRUSH¿ WILL BE RETURNED TO OLYMPUS? IF YES, WE WOULD APPRECIATE IT IF YOU COULD ALSO PROVIDE THE RETURN DATE, OR THE EXPECTED RETURN DATE FROM THE CUSTOMER. ANSWER: CANNOT RETURN. CUSTOMER ALREADY DISPOSED. REMARK: 1.THIS INQUIRY IS A CLONE OF PARENT INQUIRY INQ-516979 (PRODUCT #1: GIF-EZ1500 SN: (B)(6). THIS INQUIRY CAPTURES PRODUCT #2: BW-412T. 2. LOT/SERIAL NUMBER AND ITEM CODE ARE/IS UNKNOWN AS RELATED INFORMATION WAS NOT MENTIONED IN THE ORIGINAL INQUIRY.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1312790 SINGLE USE COMBINATION CLEANING BRUSH SINGLE USE SINGLE-ENDED CLEANING BRUSH MNL AOMORI OLYMPUS CO., LTD. BW-412T 04953170297427

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown