BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIGH FLOW INSUFFLATION UNIT

    MDR report key: 7532488 · Received May 22, 2018

    Report

    Report Number
    8010047-2018-00829
    Event Type
    Malfunction
    Date Received
    May 22, 2018
    Date of Event
    April 16, 2018
    Report Date
    August 23, 2019
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    HIF
    PMA / PMN Number
    K110294
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS IS A SUPPLEMENTAL REPORT FOR MFR REPORT #8010047-2018-00829 TO PROVIDE THE DEVICE EVALUATION RESULTS. OMSC CHECKED THE DEVICE HISTORY RECORD OF THE REFERENCED UHI-4, THERE WAS NO IRREGULARITY FOUND. THERE WERE NO FURTHER DETAILS PROVIDED. IF SIGNIFICANT ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE SUPPLEMENTED.

    Additional Manufacturer Narrative · 0

    THIS IS A SUPPLEMENTAL REPORT FOR MFR REPORT #8010047-2018-00829 TO PROVIDE THE DEVICE EVALUATION RESULTS. THE REFERENCED UHI-4 WAS RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOR EVALUATION. OMSC EVALUATED THE UHI-4 AND FOUND THAT THE UHI-4 COULD OPERATE CORRECTLY FOR THE SETTING VALUE OF THE CAVITY PRESSURE, HOWEVER THE VOLUME INDICATOR ON THE FRONT PANEL OF THE UHI-4 DISPLAYED ABNORMAL VALUE. FURTHERMORE, OMSC CHECKED THE INSIDE OF THE UHI-4 AND FOUND THAT THE BATTERY ON THE PC BOARD WAS REMOVED. ALSO, THERE WAS THE DAMAGE DUE TO IMPACT ON THE EXTERIOR OF THE UHI-4. OMSC IS CONTINUOUSLY EVALUATING THE UHI-4. THERE WERE NO FURTHER DETAILS PROVIDED. IF SIGNIFICANT ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE SUPPLEMENTED.

    Additional Manufacturer Narrative · 0

    THIS IS A SUPPLEMENTAL REPORT TO PROVIDE ADDITIONAL INFORMATION. IT WAS CONFIRMED THERE WAS RUSTY AT THE REAR PANEL OF THE SUBJECT DEVICE. OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) INVESTIGATED THE INTERNAL CIRCUIT BOARD OF THE SUBJECT DEVICE AND FOUND A FLOW SENSOR HAD MALFUNCTION. BASED ON THE INVESTIGATION RESULT SO FAR, OMSC DETERMINED THAT THE FAILURE PHENOMENON, WHICH THE PRESSURE OF THE SUBJECT DEVICE WAS ABNORMAL, WAS ATTRIBUTED TO THE MALFUNCTIONED FLOW SENSOR IN THE SUBJECT DEVICE. THE EXACT CAUSE OF MALFUNCTION OF THE FLOW SENSOR COULD NOT BE CONCLUSIVELY DETERMINED, HOWEVER THERE IS THE POSSIBILITY THAT MALFUNCTION OF THE FLOW SENSOR MIGHT BE ATTRIBUTED TO OPERATING ENVIRONMENT OR EXTERNAL IMPACTS DUE TO INAPPROPRIATE HANDLING OF THE DEVICE BY THE USER. THE UHI-4 INSTRUCTION MANUAL STATES THE APPROPRIATE HANDLING AND OPERATING ENVIRONMENT OF THE DEVICE.

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 1

    THE REFERENCED UHI-4 WAS NOT RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP.(OMSC) FOR EVALUATION, THEREFORE OMSC CANNOT EVALUATE THE UHI-4. THE TECHNICIAN OF (B)(4) CONFIRMED THE REFERENCED UHI-4 AND FOUND THAT THERE WAS NO ABNORMALITY AND IRREGULARITY. THE EXACT CAUSE OF THIS PHENOMENON CANNOT BE CONCLUSIVELY DETERMINED AT THE CURRENT MOMENT. THERE WERE NO FURTHER DETAILS PROVIDED. IF SIGNIFICANT ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE SUPPLEMENTED.

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT BEFORE THE LAPAROSCOPIC CHOLECYSTECTOMY, THE FACILITY FOUND THAT THE PRESSURE OF THE UHI-4 WAS ABNORMAL. THE PATIENT WAS ALREADY UNDER ANESTHESIA. 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
    378244 HIGH FLOW INSUFFLATION UNIT HIGH FLOW INSUFFLATION UNIT HIF OLYMPUS MEDICAL SYSTEMS CORP. UHI-4

    Patients

    Seq Age Sex Outcome Treatment
    1