BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WATER CONTAINER (LID)

    MDR report key: 23245075 · Received October 8, 2025

    Report

    Report Number
    3002808148-2025-17264
    Event Type
    Malfunction
    Date Received
    October 8, 2025
    Date of Event
    September 8, 2025
    Report Date
    December 12, 2025
    Manufacturer
    SHIRAKAWA OLYMPUS CO., LTD.
    Product Code
    FET
    PMA / PMN Number
    K954451
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE CORRECTIONS AND THE RESULTS OF THE FINAL INVESTIGATION. UPDATED FIELDS: B5; D8; D10; G2; G3; H2; H6 AND H11 CORRECTED FIELDS: E1 THE DEVICE WAS NOT RETURNED TO OLYMPUS FOR INSPECTION, AND THE REPORTED FAILURE WAS NOT CONFIRMED. A ROOT CAUSE COULD NOT BE IDENTIFIED. BASED ON THE RESULTS OF THE INVESTIGATION, THE MOST PROBABLE CAUSE WAS NOT 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 THAT THE SUBJECT DEVICE HAD A MOLD-LIKE SUBSTANCE ADHERED TO A SECTION OF THE WATER SUPPLY TUBE. THE ISSUE OCCURRED DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    AFTER THE END USER CONFIRMED THE MOLD, THE CUSTOMER REPLACED THE DEVICE WITH A NEW ONE TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2610070 WATER CONTAINER (LID) CAP FET SHIRAKAWA OLYMPUS CO., LTD. MAJ-1025

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown