BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIGH FLOW INSUFFLATION UNIT

    MDR report key: 8585429 · Received May 7, 2019

    Report

    Report Number
    8010047-2019-01870
    Event Type
    Malfunction
    Date Received
    May 7, 2019
    Date of Event
    June 30, 2018
    Report Date
    June 19, 2019
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    HIF
    PMA / PMN Number
    K014166
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE SUBJECT UHI-3 WAS NOT RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOR EVALUATION. THEREFORE, THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED. HOWEVER, THE SUBJECT UHI-3 WAS RETURNED TO OLYMPUS LOCAL REPAIR CENTER FOR THE REPAIR. AS AN EVALUATION RESULT OF THE SUBJECT UHI-3 BY A LOCAL REPAIR ENGINEER, THERE WAS NO ABNORMALITY FOUND. THE SUBJECT UHI-3 WAS RETURNED TO THE USER. AND THERE HAS BEEN NO REPORT THAT ANY FAILURES OCCURRED SINCE THE SUBJECT UHI-3 RETURNED TO THE USER. THE DEVICE HISTORY RECORD WAS REVIEWED AND FOUND NO IRREGULARITIES. BASED ON THE EVALUATION RESULT SO FAR, OMSC SURMISED THAT THE REPORTED FAILURE PHENOMENON, WHICH THE SUBJECT UHI-3 SUDDENLY INCREASED THE AIR PRESSURE, WAS CAUSED BY ANOTHER DEVICE/FACTOR OTHER THAN THE SUBJECT UHI-3.

    Additional Manufacturer Narrative · 1

    THE SUBJECT UHI-3 HAS NOT BEEN RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) YET. OMSC WILL INVESTIGATE THE SUBJECT UHI-3 TO IDENTIFY THE ROOT CAUSE OF THIS FAILURE PHENOMENON WHEN OMSC RECEIVES IT. THE UHI-3 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

    ON (B)(6) 2018, THE SUBJECT UHI-3 SUDDENLY INCREASED THE AIR PRESSURE TO THE OVERPRESSURE ALARM DURING A UTERUS ADNEXECTOMY. THE USER RESTART THE SUBJECT UHI-3 AND THE FAILURE PHENOMENON WAS RESOLVED. THE USER COMPLETED THE INTENDED PROCEDURE WITH THE SUBJECT UHI-3. THERE WAS NO REPORT OF THE PATIENT¿S INJURY REGARDING THIS EVENT ON (B)(6) 2018. THE SUBJECT UHI-3 HAD BEEN USED UNTIL (B)(6) 2019. ON (B)(6) 2019, THE SAME FAILURE, WHICH THE SUBJECT UHI-3 SUDDENLY INCREASED THE AIR PRESSURE, WAS OCCURRED AGAIN. THE USER RESTART THE SUBJECT UHI-3 BUT THE FAILURE STILL EXISTED. THE USER SUSPENDED USE OF THE SUBJECT UHI-3 AND SEND TO THE OLYMPUS REPAIR CENTER. THERE WAS NO REPORT OF THE PATIENT¿S INJURY REGARDING THIS EVENT ON (B)(6) 2019.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    380884 HIGH FLOW INSUFFLATION UNIT HIGH FLOW INSUFFLATION UNIT HIF OLYMPUS MEDICAL SYSTEMS CORP. UHI-3

    Patients

    Seq Age Sex Outcome Treatment
    1