BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIGH FLOW INSUFFLATION UNIT

    MDR report key: 7640670 · Received June 27, 2018

    Report

    Report Number
    8010047-2018-01225
    Event Type
    Malfunction
    Date Received
    June 27, 2018
    Date of Event
    May 15, 2018
    Report Date
    April 3, 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 HEALTH CARE PROFESSIONAL

    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 #8010047-2018-01225 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 CONFIRMED THAT THERE WAS NOT ANY ABNORMAL EXTERIOR ON THE MAIN PC BOARD. 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. OMSC CHECKED THE MANUFACTURE HISTORY OF THE UHI-4, THERE WAS NO IRREGULARITY FOUND. THE EXACT CAUSE OF THIS PHENOMENON COULD NOT BE CONCLUSIVELY DETERMINED, HOWEVER THERE WAS THE POSSIBILITY OF THE TEMPORARY MALFUNCTION DUE TO THE INGRESS OF THE LIQUID AND/OR FOREIGN PARTICLE INTO THE UHI-4. OLYMPUS STATED THE APPROPRIATE HANDLING OF UHI-4 AND THE COUNTER MEASURES AGAINST ABNORMALITIES IN THE INSTRUCTION MANUAL OF UHI-4. FURTHERMORE, OMSC IS SUBMITTING THIS SUPPLEMENTAL REPORT TO PROVIDE THE ADDITIONAL INFORMATION. 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 BEIJING (OSH). OSH EVALUATED THE UHI-4 AND FOUND THAT THE USER¿S REPORT COULD BE DUPLICATED. OSH EXCHANGED THE MAIN PC BOARD OF THE REFERENCED UHI-4 TO ANOTHER MAIN PC BOARD, THE UHI-4 OPERATED WITHOUT ANY PROBLEM. ALSO, THE MAIN PC BOARD OF THE REFERENCED UHI-4 WAS INSTALLED TO ANOTHER UHI-4, THEN THE UHI-4 COULD NOT OPERATE APPROPRIATELY. 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 HYSTERECTOMY PROCEDURE, THE FACILITY DETERMINED THAT THE PRESSURE OF THE UHI-4 WAS INSUFFICIENT. THE FACILITY CHANGED THE UHI-4 TO THE UHI-3 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
    486668 HIGH FLOW INSUFFLATION UNIT HIGH FLOW INSUFFLATION UNIT HIF OLYMPUS MEDICAL SYSTEMS CORP. UHI-4

    Patients

    Seq Age Sex Outcome Treatment
    1