BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WATER CONTAINER (LID)

    MDR report key: 19090923 · Received April 11, 2024

    Report

    Report Number
    3002808148-2024-03416
    Event Type
    Malfunction
    Date Received
    April 11, 2024
    Report Date
    September 3, 2024
    Manufacturer
    SHIRAKAWA OLYMPUS CO., LTD.
    Product Code
    FET
    UDI-DI
    04953170079252
    PMA / PMN Number
    K954451
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    E1 ESTABLISHMENT NAME: (B)(6) HOSPITAL. THE EVALUATION OF THE EVENT IS ONGOING. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE RESULTS OF THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. ADDITIONAL INFORMATION ADDED TO FIELD H6. THE DEVICE HISTORY RECORD WAS UNABLE TO BE REVIEWED FOR THIS DEVICE SINCE THE SERIAL NUMBER WAS NOT PROVIDED. HOWEVER, OLYMPUS ONLY RELEASES PRODUCTS TO MARKET THAT MEET ALL MANUFACTURING SPECIFICATIONS AND FINAL PRODUCT RELEASE CRITERIA. THE DEVICE WAS NOT RETURNED TO OLYMPUS FOR INSPECTION, AND THE CUSTOMER'S ALLEGATION WAS CONFIRMED. BASED ON THE RESULTS OF THE INVESTIGATION, A PROBABLE CAUSE WAS NOT IDENTIFIED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED, THE WATER CONTAINER HAD STERAD STERILIZATION USED WHICH IS NOT RECOMMENDED AND AGAINST REPROCESSING. THE ISSUE OCCURRED DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1029952 WATER CONTAINER (LID) CAP FET SHIRAKAWA OLYMPUS CO., LTD. MAJ-1025 04953170079252

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown