BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIGH FLOW INSUFFLATION UNIT

    MDR report key: 9675407 · Received February 6, 2020

    Report

    Report Number
    8010047-2020-01177
    Event Type
    Malfunction
    Date Received
    February 6, 2020
    Date of Event
    January 20, 2020
    Report Date
    March 4, 2020
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    HIF
    PMA / PMN Number
    K122180
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    THE SUBJECT UHI-4 WAS RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOR EVALUATION. DURING THE EVALUATION BY OMSC, THE REPORTED PHENOMENON WAS NOT DUPLICATED. ALSO OMSC CONFIRMED THE SUBJECT DEVICE AND FOUND FOLLOWING. THERE WAS NO ABNORMALITY OF THE OUTSIDE AND INSIDE OF THE SUBJECT DEVICE. THERE WAS NO ABNORMALITY OF THE RESULT OF THE INSPECTION OF THE INSUFFLATION OF THE SUBJECT DEVICE. OMSC REVIEWED THE MANUFACTURING HISTORY OF THE SUBJECT DEVICE AND CONFIRMED NO IRREGULARITY. SINCE THE REPORTED PHENOMENON WAS NOT REPRODUCED, THE EXACT CAUSE WAS UNKNOWN, HOWEVER THE FOLLOWING WAS SUPPOSED TO BE THE CAUSE. TEMPORARY FAILURE OF THE DECOMPRESSOR OF THE SUBJECT DEVICE. TEMPORARY RESONANCE OF COMPONENTS INSIDE THE SUBJECT DEVICE. THE INSTRUCTION MANUAL OF THE SUBJECT DEVICE STATES THE CORRESPONDING METHOD IN CASE OF AN ABNORMALITY.

    Additional Manufacturer Narrative · 1

    THE SUBJECT UHI-4 WAS RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOR EVALUATION. OMSC WILL START EVALUATING SUBJECT DEVICE. THERE WERE NO FURTHER DETAILS PROVIDED. IF SIGNIFICANT ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE SUPPLEMENTED.

    Description of Event or Problem · 1

    DURING SIGMOID COLECTOMY WITH THE UHI-4, ABNORMAL NOISE WAS GENERATED FROM THE UHI-4. THERE WAS NO ABNORMALITY ON THE SUBJECT UHI-4 OTHER THAN ABNORMAL NOISE WAS GENERATED FROM THE SUBJECT UHI-4. ABOUT 5 TO 6 HOURS AFTER THE START OF THE PROCEDURE, 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
    138649 HIGH FLOW INSUFFLATION UNIT HIGH FLOW INSUFFLATION UNIT HIF OLYMPUS MEDICAL SYSTEMS CORP. UHI-4

    Patients

    Seq Age Sex Outcome Treatment
    1