BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIGH FLOW INSUFFLATION UNIT

    MDR report key: 18370063 · Received December 20, 2023

    Report

    Report Number
    3002808148-2023-14584
    Event Type
    Malfunction
    Date Received
    December 20, 2023
    Report Date
    September 16, 2024
    Manufacturer
    SHIRAKAWA OLYMPUS CO., LTD.
    Product Code
    HIF
    UDI-DI
    04953170324147
    PMA / PMN Number
    K122180
    Removal / Correction Number
    Z-0075-2024
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    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 SPECIFIC CAUSE OF THE PHENOMENON WAS NOT ESTABLISHED. 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 CAPA-201353.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED TO OLYMPUS, AND IT IS NOT EXPECTED TO BE RETURNED FOR EVALUATION OF THE REPORTED ISSUE. ADDITIONAL DETAILS HAVE BEEN REQUESTED REGARDING THE REPORTED EVENT. AT THIS TIME, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED. THE INVESTIGATION IS ONGOING, AND A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION OR IF ANY ADDITIONAL INFORMATION IS PROVIDED BY THE USER FACILITY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DIGESTIVE SURGEONS WERE EXPERIENCING MORE SMOKE THAN USUAL WHILE USING THE HIGH FLOW INSUFFLATION UNIT DURING UNSPECIFIED THERAPEUTIC PROCEDURES. THE OPERATING ROOM NURSES BELIEVED IT COULD BE LINKED TO A MALFUNCTION OF THE INSUFFLATOR AND THE OVERPRESSURE ALARM. THERE WAS NO REPORT OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2152953 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