BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIGH FLOW INSUFFLATION UNIT

    MDR report key: 7680484 · Received July 11, 2018

    Report

    Report Number
    8010047-2018-01319
    Event Type
    Malfunction
    Date Received
    July 11, 2018
    Date of Event
    June 13, 2018
    Report Date
    March 11, 2019
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    HIF
    PMA / PMN Number
    K110294
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS SUBMITTING TO CORRECT "DEVICE PRODUCT CODE".

    Additional Manufacturer Narrative · 0

    THIS IS A SUPPLEMENTAL REPORT FOR MFR REPORT #8010047-2018-01319 TO PROVIDE THE DEVICE EVALUATION RESULTS. THE REFERENCED UHI-4 WAS NOT RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP.(OMSC) FOR EVALUATION, HOWEVER THE MAIN PC BOARD WHICH HAD BEEN ASSEMBLED TO THE REFERENCED UHI-4 WAS RETURNED TO OMSC. OMSC EVALUATED THE REFERENCED MAIN PC BOARD IN COMBINATION WITH THE UHI-4 OWNED BY OMSC AND FOUND THAT THERE WAS NO ABNORMALITY AND IRREGULARITY AND COULD NOT CONFIRM THE USER¿S REPORT. THE EXACT CAUSE OF THIS PHENOMENON COULD NOT BE CONCLUSIVELY DETERMINED, HOWEVER THERE WAS THE POSSIBILITY THAT THE SUPPLY OF CO2 TO THE UHI-4 HAD SOME PROBLEM (THE VALVE OF THE CO2 SUPPLY WAS SHUT OFF, THE CYLINDER HOSE WAS KINKED, THERE WAS THE FOREIGN PARTICLE INSIDE THE CYLINDER HOSE, AND SO ON). ALSO, THE MAIN PC BOARD RECORDED THE ERROR LOG WHICH INDICATED THE ABNORMALITY OF THE HYDRAULIC LINE PRESSURE SENSOR. THERE WAS THE POSSIBILITY OF THE ERROR LOG WAS ATTRIBUTED TO THE INAPPROPRIATE HANDLING BY, SUCH AS THE INGRESS OF THE LIQUID AND/OR FOREIGN PARTICLE INTO THE UHI-4, OR THE USAGE ENVIRONMENT OF USAGE, SUCH AS THE TEMPORARY MALFUNCTION DUE TO THE NOISE AND/OR STATIC ELECTRICITY. CONSEQUENTLY THERE WAS THE POSSIBILITY THE ERROR CAUSED THAT THE UHI-4 COULD NOT OPERATE CORRECTLY. OLYMPUS STATED THE APPROPRIATE HANDLING OF UHI-4 AND THE COUNTER MEASURES AGAINST ABNORMALITIES IN THE INSTRUCTION MANUAL OF UHI-4. THERE WERE NO FURTHER DETAILS PROVIDED. IF SIGNIFICANT ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE SUPPLEMENTED.

    Additional Manufacturer Narrative · 1

    THE REFERENCED UHI-4 WAS NOT RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOR EVALUATION AT THIS TIME; THEREFORE, OMSC COULD NOT EVALUATE THE UHI-4. THE UHI-4 WAS RETURNED TO OLYMPUS (B)(4). (B)(4) PERFORMED THE VISUAL INSPECTIONS AND FOUND THAT THERE WAS NO ABNORMALITY ON THE EXTERIOR AND INSIDE OF THE UHI-4. ALSO, (B)(4) FOUND THAT THE UHI-4 OPERATED APPROPRIATELY. HOWEVER, THE UHI-4 BEGAN TO ALARM AND THE FRONT PANEL DISPLAY WENT BLANK AN HOUR AFTER ACTIVATING THE UHI-4. (B)(4) ESTIMATED THAT THIS PHENOMENON WAS ATTRIBUTED TO THE FAULT OF THE MAIN PC BOARD OF THE UHI-4. THE REFERENCED UHI-4 IS PLANNED TO RETURN TO OMSC. THERE WERE NO FURTHER DETAILS PROVIDED. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED AT THIS TIME. IF ADDITIONAL INFORMATION, THIS REPORT WILL BE SUPPLEMENTED.

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT DURING THE UNSPECIFIED PROCEDURE, THE UHI-4 DISPLAYED THE INDICATION MEANING THE CO2 CYLINDER WAS EMPTY. HOWEVER, THE FACILITY CONFIRMED THAT THE CO2 CYLINDER WAS FULL. THE FACILITY CHANGED THE UHI-4 TO THE OTHER SIMILAR DEVICE AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORT OF THE PATIENT¿S INJURY REGARDING THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    522122 HIGH FLOW INSUFFLATION UNIT HIGH FLOW INSUFFLATION UNIT HIF OLYMPUS MEDICAL SYSTEMS CORP. UHI-4

    Patients

    Seq Age Sex Outcome Treatment
    1