BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIGH FLOW INSUFFLATION UNIT

    MDR report key: 7463504 · Received April 26, 2018

    Report

    Report Number
    8010047-2018-00757
    Event Type
    Malfunction
    Date Received
    April 26, 2018
    Date of Event
    April 11, 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
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THIS IS A SUPPLEMENTAL REPORT FOR MFR REPORT #8010047-2018-00757 TO PROVIDE THE DEVICE EVALUATION RESULTS. THE REFERENCED UHI-4 WAS NOT RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP.(OMSC) FOR EVALUATION, HOWEVER THE MAIN PC BOARD WHICH HAD BEEN ASSEMBLED TO THE REFERENCED UHI-4 WAS RETURNED TO OMSC. OMSC EVALUATED THE REFERENCED MAIN PC BOARD IN COMBINATION WITH THE UHI-4 OWNED BY OMSC 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 SUPPLY OF CO2 TO THE UHI-4 HAD SOME PROBLEM, AND/OR THE UHI-4 HAPPENED TO HAVE SOME TEMPORARY FAILURE ACCIDENTALLY. 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 IS A SUPPLEMENTAL REPORT FOR MFR REPORT #8010047-2018-00757 TO PROVIDE THE DEVICE EVALUATION RESULTS. OMSC CHECKED THE DEVICE HISTORY RECORD OF THE REFERENCED UHI-4, THERE WAS NO IRREGULARITY FOUND. 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 WAS NOT RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP.(OMSC) FOR EVALUATION, THEREFORE OMSC CANNOT EVALUATE THE UHI-4 AT THE CURRENT MOMENT. ALSO, IT IS NOT SURE IF THE UHI-4 WILL BE RETURNED TO OMSC FOR EVALUATION. 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.

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT AT THE OUTSET OF THE LAPAROSCOPIC CHOLECYSTECTOMY, THE POWER OF THE UHI-4 SHUT DOWN WITHOUT ANY OPERATION. THE FACILITY STAFF TURNED ON THE UHI-4, HOWEVER THE UHI-4 COULD NOT BE ACTIVATED CORRECTLY WITH HIGH PITCH CONSISTENT BEEP. THE FACILITY CHANGED THE UHI-4 TO THE OTHER UNSPECIFIED 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
    310162 HIGH FLOW INSUFFLATION UNIT HIGH FLOW INSUFFLATION UNIT HIF OLYMPUS MEDICAL SYSTEMS CORP. UHI-4

    Patients

    Seq Age Sex Outcome Treatment
    1