BEUDAMED
    FDA Adverse Event Other Summary report: N

    HIGH FLOW INSUFFLATION UNIT

    MDR report key: 2920689 · Received January 11, 2013

    Report

    Report Number
    8010047-2012-00467
    Event Type
    Other
    Date Received
    January 11, 2013
    Date of Event
    December 17, 2012
    Report Date
    December 19, 2012
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    HIF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REFERENCED DEVICE WAS RETURNED TO OLYMPUS FOR EVALUATION. THE EVALUATION COULD NOT CONFIRM USER'S REPORT. THE EVALUATION FOUND THAT THE UHI-3 WORKED WITHOUT ANY PROBLEM. ALSO, OLYMPUS CHECKED THE MFR HISTORY OF THE SUBJECT DEVICE, THERE WAS NO IRREGULARITY FOUND THE EXACT CAUSE OF THE EVENT COULD NOT BE CONCLUSIVELY DETERMINED, HOWEVER THE PT CONDITION OR USER'S HANDLING CANNOT BE RULED OUT AS A CONTRIBUTORY FACTOR. THIS REPORT IS BEING SUBMITTED AS A MEDICAL DEVICE REPORT IN AN ABUNDANCE OF CAUTION

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT DURING UNSPECIFIED LAPAROSCOPIC PROCEDURE, 10 MINUTES AFTER STARTING THE PROCEDURE, THE PT'S HEART RATE DROPPED. THE ABDOMINAL PRESSURE INDICATOR OF THE DEVICE SHOWED 30MMHG. THE HEART RATE BECAME STABLE AFTER REDUCING THE ABDOMINAL PRESSURE BY OPENING THE VALVE OF A TROCAR. THE PROCEDURE WAS REPORTEDLY COMPLETED WITH THE DEVICE. THE PT WAS REPORTEDLY IN STABLE CONDITION AFTER THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    17728 HIGH FLOW INSUFFLATION UNIT INSUFFLATOR HIF OLYMPUS MEDICAL SYSTEMS CORPORATION UHI-3 NA

    Patients

    Seq Age Sex Outcome Treatment
    1