BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIGH FLOW INSUFFLATION UNIT

    MDR report key: 9325312 · Received November 14, 2019

    Report

    Report Number
    8010047-2019-03971
    Event Type
    Malfunction
    Date Received
    November 14, 2019
    Date of Event
    October 14, 2019
    Report Date
    January 10, 2020
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    HIF
    PMA / PMN Number
    K122180
    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 #8010047-2019-03971. OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) COULD NOT INVESTIGATE THE SUBJECT UHI-4, BECAUSE THE SUBJECT UHI-4 WAS NOT RETURNED TO OMSC. OMSC REVIEWED THE MANUFACTURING HISTORY OF THE SUBJECT DEVICE AND CONFIRMED NO IRREGULARITY. SINCE THE SUBJECT DEVICE WAS NOT RETURNED, THE EXACT CAUSE WAS UNKNOWN. THE INSTRUCTION MANUAL OF THE SUBJECT DEVICE STATES THE CORRESPONDING METHOD IN CASE OF AN ABNORMALITY. IF SIGNIFICANT ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE SUPPLEMENTED.

    Additional Manufacturer Narrative · 1

    THE SUBJECT UHI-4 HAS NOT BEEN RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) YET. THERE WERE NO FURTHER DETAILS PROVIDED. IF SIGNIFICANT ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE SUPPLEMENTED.

    Description of Event or Problem · 1

    DURING LAPAROSCOPIC PELVIC ADHESIONS RELEASE, MYOMECTOMY, INTESTINAL ADHESION SEPARATION, UNILATERAL SALPINGECTOMY, PELVIC ENDOMETRIOSIS ELECTROCOAGULATION WITH THE UHI-4, THE SUBJECT UHI-4 COULD NOT SUPPLY CO2 TO THE PATIENT. THE USER REPLACED THE SUBJECT UHI-4 TO ANOTHER UNSPECIFIED DEVICE TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF THE PATIENT INJURY OTHER THAN REPLACING THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1118505 HIGH FLOW INSUFFLATION UNIT HIGH FLOW INSUFFLATION UNIT HIF OLYMPUS MEDICAL SYSTEMS CORP. UHI-4

    Patients

    Seq Age Sex Outcome Treatment
    1