BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIGH FLOW INSUFFLATION UNIT

    MDR report key: 10676294 · Received October 14, 2020

    Report

    Report Number
    8010047-2020-07654
    Event Type
    Malfunction
    Date Received
    October 14, 2020
    Date of Event
    September 17, 2020
    Report Date
    October 14, 2020
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    HIF
    PMA / PMN Number
    K122180
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SINCE THE SUBJECT DEVICE HAS NOT BEEN RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOR THE EVALUATION, THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED.

    Description of Event or Problem · 1

    OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED FROM THE USER THAT THE PRESSURE OF THE SUBJECT DEVICE WAS UNSTABLE AND THE CAVITY PRESSURE INDICATOR ON THE FRONT PANEL OF THE SUBJECT DEVICE DISPLAYED 0 (ZERO) MMHG DURING THE UNSPECIFIED LAPAROSCOPIC SURGERY. THE USER REPLACED THE SUBJECT DEVICE TO ANOTHER DEVICE AND COMPLETED THE PROCEDURE. THERE WAS NO PATIENT INJURY ASSOCIATED WITH THIS REPORT. IT WAS NOT PROVIDED OTHER DETAILED INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1141602 HIGH FLOW INSUFFLATION UNIT HIGH FLOW INSUFFLATION UNIT HIF OLYMPUS MEDICAL SYSTEMS CORP. UHI-4

    Patients

    Seq Age Sex Outcome Treatment
    1