BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIGH FLOW INSUFFLATION UNIT

    MDR report key: 7854462 · Received September 7, 2018

    Report

    Report Number
    8010047-2018-01744
    Event Type
    Malfunction
    Date Received
    September 7, 2018
    Date of Event
    August 13, 2018
    Report Date
    April 5, 2019
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    HIF
    PMA / PMN Number
    K110294
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    THIS IS A SUPPLEMENTAL REPORT FOR MFR REPORT #8010047-2018-01744 TO PROVIDE THE DEVICE EVALUATION RESULTS. THE REFERENCED UHI-4 WAS NOT RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOR EVALUATION. THE EXACT CAUSE OF THIS PHENOMENON COULD NOT BE CONCLUSIVELY DETERMINED, HOWEVER THERE WAS THE POSSIBILITY OF THIS PHENOMENON WAS ATTRIBUTED TO SOME TEMPORARY PROBLEM OF THE CO2 SUPPLY SYSTEM, OR THE USAGE ENVIRONMENT OF THE FACILITY SUCH AS THE ELECTRICAL NOISE AND/OR HIGH LEVEL STATIC ELECTRICITY AND SO ON. OMSC CHECKED THE MANUFACTURE HISTORY OF THE UHI-4, THERE WAS NO IRREGULARITY FOUND. 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 · 1

    THE REFERENCED UHI-4 WAS NOT RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP.(OMSC) FOR EVALUATION AT THIS TIME; THEREFORE OMSC COULD NOT EVALUATE THE UHI-4. THE UHI-4 WAS RETURNED TO OLYMPUS (B)(4). (B)(4) EVALUATED THE UHI-4 AND FOUND THAT THE USER¿S REPORT COULD NOT BE DUPLICATED AND THE UHI-4 OPERATED WITHOUT ANY PROBLEM. ALSO THERE WAS NOT ANY ABNORMAL EXTERIOR ON THE UHI-4. THE REFERENCED UHI-4 IS PLANNED TO RETURN TO OMSC. THERE WERE NO FURTHER DETAILS PROVIDED. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED AT THIS TIME. IF ADDITIONAL INFORMATION, THIS REPORT WILL BE SUPPLEMENTED.

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT DURING THE UNSPECIFIED LAPAROSCOPIC PROCEDURE, THE CAVITY PRESSURE OF THE UHI-4 BECAME TOO LOW. THE FACILITY CHANGED THE UHI-4 TO THE OTHER SIMILAR DEVICE 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
    695217 HIGH FLOW INSUFFLATION UNIT HIGH FLOW INSUFFLATION UNIT HIF OLYMPUS MEDICAL SYSTEMS CORP. UHI-4

    Patients

    Seq Age Sex Outcome Treatment
    1