BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WASHING PIPE

    MDR report key: 21673651 · Received March 23, 2025

    Report

    Report Number
    9614641-2025-00355
    Event Type
    Malfunction
    Date Received
    March 23, 2025
    Date of Event
    February 21, 2025
    Report Date
    July 2, 2025
    Manufacturer
    AOMORI OLYMPUS CO., LTD.
    Product Code
    EOB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H4: THE EXACT MANUFACTURING DATE IS UNKNOWN. THE DEVICE WAS INSPECTED AND FOREIGN MATERIAL WAS OBSERVED IN THE NOZZLE OF THE DEVICE. THE INVESTIGATION WAS UNABLE TO DETERMINE THE CAUSE OF THE FOREIGN MATERIAL. ACCORDING TO THE CUSTOMER, CLEANING WAS IMPLEMENTED ACCORDING TO THE INSTRUCTION MANUAL. THIS REPORT WILL BE SUPPLEMENTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE AT A LATER DATE. OLYMPUS WILL CONTINUE TO MONITOR THE FIELD PERFORMANCE OF THIS DEVICE.

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE ADDITIONAL RESULTS OF THE FINAL INVESTIGATION. A MATERIAL ANALYSIS WAS CONDUCTED ON THE FOREIGN MATERIAL OBSERVED IN THE NOZZLE. THE FOREIGN MATERIAL IS INFERRED TO HAVE ORIGINATED FROM A SURFACTANT AND IS LIKELY RESIDUE FROM A CHEMICAL AGENT OR CLEANING SOLUTION. NO BIOLOGICAL SUBSTANCES (E.G., PROTEINS) WERE DETECTED. THE RESIDUE OF CHEMICAL AGENTS OR CLEANING SOLUTIONS MAY HAVE RESULTED FROM INSUFFICIENT CLEANING OR RINSING. THE RUST MAY HAVE FORMED AS A RESULT OF RESIDUAL CHEMICAL OR CLEANING AGENTS PROMOTING CORROSION OF THE NOZZLE. A DEFINITIVE ROOT CAUSE CANNOT BE IDENTIFIED.

    Description of Event or Problem · 0

    DURING THE DEVICE EVALUATION, FOREIGN MATTER WAS FOUND ADHERING TO THE INSIDE OF THE NOZZLE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    DURING THE DEVICE EVALUATION, FOREIGN MATTER WAS FOUND ADHERING TO THE INSIDE OF THE NOZZLE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    490879 WASHING PIPE WASHING PIPE EOB AOMORI OLYMPUS CO., LTD. 6233064 11K

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown