BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIGH FLOW INSUFFLATION UNIT

    MDR report key: 8513124 · Received April 15, 2019

    Report

    Report Number
    8010047-2019-01679
    Event Type
    Malfunction
    Date Received
    April 15, 2019
    Date of Event
    March 31, 2019
    Report Date
    April 18, 2019
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    HIF
    PMA / PMN Number
    K122180
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    THE SUBJECT UHI-4 HAS NOT BEEN RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC). OMSC ANALYZED THE DHR OF THE SUBJECT UHI-4, NO ABNORMALITY WAS FOUND. THERE IS A POSSIBILITY THAT CO2 LEAKED OUT FROM THE CONNECTION PORT OF THE HIGH PRESSURE HOSE, BECAUSE THE CONNECTION WITH THE HIGH PRESSURE HOSE WAS NOT SCREWED PROPERLY, FROM THE INFORMATION OF THE EVENT OCCURRENCE. THERE IS A POSSIBILITY THAT IS RESULTED FROM HANDLING OF THE USER.

    Additional Manufacturer Narrative · 1

    THE SUBJECT UHI-4 WAS NOT RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC). OMSC WILL INVESTIGATE THE SUBJECT UHI-4 TO IDENTIFY THE ROOT CAUSE OF THIS FAILURE PHENOMENON WHEN OMSC RECEIVES IT. THE UHI-4 INSTRUCTION MANUAL STATES THE CORRESPONDING METHOD WHEN THERE IS AN ABNORMALITY FOR THE DEVICE. THERE WERE NO FURTHER DETAILS PROVIDED. IF SIGNIFICANT ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE SUPPLEMENTED.

    Description of Event or Problem · 1

    WHEN PNEUMOPERITONEUM WAS STARTED TO PERFORM A PROCEDURE OF LAPAROSCOPIC LEFT NEPHRECTOMY USING UHI-4, CO2 LEAKED OUT FROM THE CONNECTION PORT OF THE SUBJECT UHI-4 AND THE HIGH PRESSURE HOSE. THE SUBJECT UHI-4 WAS REPLACED WITH A SPARE DEVICE, AND THE PROCEDURE WAS CONTINUED AND COMPLETED. AFTER THAT, WHEN THE USER CONFIRMED THE SUBJECT UHI-4, IT SEEMED TO BE LEAKING BECAUSE THE HOSE CONNECTION WAS INSUFFICIENT. THERE WAS NO REPORT OF THE PATIENT¿S INJURY REGARDING THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    306176 HIGH FLOW INSUFFLATION UNIT HIGH FLOW INSUFFLATION UNIT HIF OLYMPUS MEDICAL SYSTEMS CORP. UHI-4

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR