BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHANNEL CLEANING BRUSH

    MDR report key: 21678221 · Received March 24, 2025

    Report

    Report Number
    3002808148-2025-04968
    Event Type
    Malfunction
    Date Received
    March 24, 2025
    Date of Event
    February 25, 2025
    Report Date
    June 18, 2025
    Manufacturer
    SHIRAKAWA OLYMPUS CO., LTD.
    Product Code
    MNL
    UDI-DI
    04953170022630
    PMA / PMN Number
    CLASS1-EXMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE NOT RETURNED: UPDATED FIELDS: D8, D9, H2, H6, AND H11 THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE RESULTS OF THE LEGAL MANUFACTURER'S 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.

    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 CUSTOMER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CHANNEL CLEANING BRUSH GOT STUCK IN THE INSTRUMENT CHANNEL. THE EVENT OCCURRED DURING SET UP. THERE WAS NO PATIENT INVOLVEMENT. NOTE: 1. THIS INQUIRY WAS CLONED FROM INQUIRY INQ-245899 BECAUSE MULTIPLE DEVICES WERE REPORTED. INQUIRY INQ-245899 CAPTURES DEVICE GIF-H190, AND INQUIRY INQ-247486 CAPTURES DEVICE: BRUSH. 2. THE PRODUCT IS "BRUSH", SINCE THE MODEL NUMBER AND ITEM CODE ARE UNKNOWN, "MLA-UNKNOWN" WAS SELECTED FIRST. 2 OUT OF 2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    768565 CHANNEL CLEANING BRUSH CLEANING BRUSH MNL SHIRAKAWA OLYMPUS CO., LTD. BW-20T 04953170022630

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown GIF-H190.