BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIGH FLOW INSUFFLATION UNIT

    MDR report key: 17931624 · Received October 13, 2023

    Report

    Report Number
    3002808148-2023-11253
    Event Type
    Malfunction
    Date Received
    October 13, 2023
    Date of Event
    May 12, 2023
    Report Date
    September 19, 2024
    Manufacturer
    SHIRAKAWA OLYMPUS CO., LTD.
    Product Code
    HIF
    UDI-DI
    04953170324147
    PMA / PMN Number
    K122180
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. BASED ON THE RESULTS OF THE INVESTIGATION, THE ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED ALTHOUGH IT CAN BE PRESUMED IT WAS DUE TO MAIN BOARD FAILURE. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. G2- ADDED INFORMATION. AS A RESULT OF FORMAL INVESTIGATION, FOR OVERPRESSURE-RELATED ADVERSE EVENTS WHEN USING UHI-4, A CAPA (CAPA-201353) WAS OPENED AND OLYMPUS DECIDED TO CONDUCT A CLASS 1 RECALL OF UHI-4. (RECALL NUMBER: Z-0075-2024). OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED TO OLYMPUS FOR EVALUATION, AND THE CUSTOMER'S ALLEGATION WAS CONFIRMED. THE EVALUATION FOUND EXCESSIVE PRESSURE WHEN INFLATED, AND THE PRESSURE SENSOR ABNORMALITY WAS DUE TO THE MAIN BOARD FAILURE CAUSING ERROR E03. THE INVESTIGATION IS ONGOING, AND FOLLOW-UP WITH THE USER FACILITY IS BEING PERFORMED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON THE INVESTIGATION'S COMPLETION OR IF THE USER FACILITY PROVIDES ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    THE OLYMPUS ADMINISTRATIVE REPRESENTATIVE REPORTED (ON BEHALF OF THE CUSTOMER) THAT THE HIGH FLOW INSUFFLATION UNIT HAD EXCESSIVE PRESSURE WHEN INFLATED, CAUSING A PRESSURE SENSOR ABNORMALITY. THE ISSUE WAS FOUND DURING PREPARATION FOR USE BEFORE A THERAPEUTIC PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    631559 HIGH FLOW INSUFFLATION UNIT HIGH FLOW INSUFFLATION UNIT HIF SHIRAKAWA OLYMPUS CO., LTD. UHI-4 04953170324147

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown