BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIGH FLOW INSUFFLATION UNIT

    MDR report key: 8013305 · Received October 29, 2018

    Report

    Report Number
    8010047-2018-02077
    Event Type
    Malfunction
    Date Received
    October 29, 2018
    Date of Event
    October 11, 2018
    Report Date
    March 15, 2019
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    HIF
    PMA / PMN Number
    K014166
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    NO FAULT WAS FOUND WITH THE SUBJECT UHI-3, AS A RESULT OF INVESTIGATION BY AN OLYMPUS LOCAL ENGINEER. THERE WERE NO FURTHER DETAILS PROVIDED. IF SIGNIFICANT ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE SUPPLEMENTED.

    Additional Manufacturer Narrative · 0

    OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) COULD NOT INVESTIGATE THE SUBJECT UHI-3, BECAUSE THE SUBJECT UHI-3 WAS NOT RETURNED TO OMSC. OMSC CHECKED THE DEVICE HISTORY RECORD OF THE SUBJECT UHI-3, AND THERE WAS NO IRREGULARITY FOUND. IN ADDITION, NO FAULT WAS FOUND WITH THE SUBJECT UHI-3, AS A RESULT OF INVESTIGATION BY AN OLYMPUS LOCAL ENGINEER. THEREFORE, OMSC JUDGED THAT THE SUBJECT UHI-3 MEETS THE SPECIFICATIONS. THE ROOT CAUSE OF THIS EVENT COULD NOT BE CONCLUSIVELY DETERMINED. HOWEVER, OMSC SURMISED THAT THE POSSIBLE CAUSE OF THIS EVENT WAS ANY KIND OF ACCIDENTAL FACTORS IN THEORY. THERE WERE NO FURTHER DETAILS PROVIDED. IF SIGNIFICANT ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE SUPPLEMENTED.

    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

    THE SUBJECT UHI-3 WAS USED FOR AN UNSPECIFIED LAPAROSCOPIC PROCEDURE. DURING THE PROCEDURE, THE SUBJECT UHI-3 DIDN¿T WORK PROPERLY AND DIDN'T INSUFFLATE CO2 TO THE ABDOMINAL CAVITY. THE USER REPLACED THE SUBJECT UHI-3 WITH ANOTHER DEVICE AND COMPLETED THE PROCEDURE. THERE WAS NO REPORT OF THE PATIENT¿S INJURY REGARDING THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    857000 HIGH FLOW INSUFFLATION UNIT HIGH FLOW INSUFFLATION UNIT HIF OLYMPUS MEDICAL SYSTEMS CORP. UHI-3

    Patients

    Seq Age Sex Outcome Treatment
    1