BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIGH FLOW INSUFFLATION UNIT

    MDR report key: 7291553 · Received February 23, 2018

    Report

    Report Number
    8010047-2018-00306
    Event Type
    Malfunction
    Date Received
    February 23, 2018
    Report Date
    March 11, 2019
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    HIF
    PMA / PMN Number
    PK110294
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS IS A SUPPLEMENTAL REPORT FOR MFR REPORT #8010047-2018-00306 TO PROVIDE THE DEVICE EVALUATION RESULTS. THE REFERENCED UHI-4 WAS RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOR EVALUATION. OMSC EVALUATED THE UHI-4 AND FOUND THAT THERE WAS NO ABNORMALITY AND IRREGULARITY AND COULD NOT CONFIRM THE USER¿S REPORT. THE EXACT CAUSE OF THIS PHENOMENON COULD NOT BE CONCLUSIVELY DETERMINED, HOWEVER THERE WAS THE POSSIBILITY THAT THE TUBE WAS PARTIALLY CLOGGED, THE CAVITY MODE WAS SET TO ¿SMALL¿, OR THE ACCIDENTAL MALFUNCTION OCCURRED TEMPORARILY. CONSEQUENTLY THE UHI-4 COULD NOT OPERATE CORRECTLY THEN COULD NOT INSUFFLATE THE PATIENT. OLYMPUS STATED THE APPROPRIATE HANDLING OF UHI-4 AND THE COUNTER MEASURES AGAINST ABNORMALITIES IN THE INSTRUCTION MANUAL OF UHI-4. THERE WERE NO FURTHER DETAILS PROVIDED. IF SIGNIFICANT ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE SUPPLEMENTED.

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS SUBMITTING TO CORRECT "DEVICE PRODUCT CODE".

    Additional Manufacturer Narrative · 1

    THE REFERENCED UHI-4 IS PLANNED TO RETURN TO OLYMPUS MEDICAL SYSTEMS CORP.(OMSC) FOR EVALUATION, HOWEVER THE UHI-4 IS NOT RETURNED TO OMSC YET, THEREFORE OMSC CANNOT EVALUATE THE UHI-4. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED AT THIS TIME. IF SIGNIFICANT ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE SUPPLEMENTED. THIS REPORT IS BEING SUBMITTED AS A MEDICAL DEVICE REPORT IN AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT DURING THE UNSPECIFIED SURGERY, THE CAVITY PRESSURE DID NOT INCREASE TO THE SET PRESSURE OF THE UHI-4. THE FACILITY CHANGED THE UHI-4 TO THE UHI-3 AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORT OF THE PATIENT¿S INJURY REGARDING THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    137278 HIGH FLOW INSUFFLATION UNIT HIGH FLOW INSUFFLATION UNIT HIF OLYMPUS MEDICAL SYSTEMS CORP. UHI-4

    Patients

    Seq Age Sex Outcome Treatment
    1