BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIGH FLOW INSUFFLATION UNIT

    MDR report key: 8489994 · Received April 7, 2019

    Report

    Report Number
    8010047-2019-01605
    Event Type
    Malfunction
    Date Received
    April 7, 2019
    Date of Event
    July 22, 2015
    Report Date
    March 13, 2020
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    HIF
    UDI-DI
    04953170140297
    PMA / PMN Number
    K014166
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS IS A SUPPLEMENTAL REPORT TO PROVIDE ADDITIONAL INFORMATION. THE SUBJECT DEVICE WAS NOT RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC). THE USER DID NOT PROVIDED FURTHER INFORMATION ABOUT THIS EVENT. THE DEVICE HISTORY RECORD WAS REVIEWED AND FOUND NO IRREGULARITIES. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED.

    Additional Manufacturer Narrative · 1

    THE SUBJECT UHI-3 WAS NOT RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC). 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

    (B)(6) INFORMED OLYMPUS (B)(4) OF THE EVENT BELOW ON MARCH 13TH, 2019. ON (B)(6) 2015, DURING LAPAROSCOPIC FALLOPIAN TUBE RESECTION USING UHI-3, THE CARBON DIOXIDE FLOW FROM THE SUBJECT UHI-3 RAPIDLY INCREASED, CAUSING EXCESSIVE ABDOMINAL DISTENSION OF THE PATIENT. THE PATIENT WAS PREGNANT. THE PHENOMENON BROUGHT UNKNOWN RISKS TO THE PREGNANT WOMAN AND FETUS. AFTER ABOUT 20 MINUTES OF ADJUSTMENT, THE SUBJECT UHI-3 WORKED NORMALLY, AND THE PROCEDURE WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283014 HIGH FLOW INSUFFLATION UNIT HIGH FLOW INSUFFLATION UNIT HIF OLYMPUS MEDICAL SYSTEMS CORP. UHI-3 04953170140297

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR