BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIGH FLOW INSUFFLATION UNIT

    MDR report key: 7387895 · Received April 2, 2018

    Report

    Report Number
    8010047-2018-00557
    Event Type
    Malfunction
    Date Received
    April 2, 2018
    Date of Event
    March 6, 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 # 8010047-2018-00557 TO PROVIDE THE DEVICE EVALUATION RESULTS. THE REFERENCED UHI-4 WAS NOT RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOR EVALUATION, HOWEVER THE POWER UNIT WHICH HAD BEEN ASSEMBLED TO THE REFERENCED UHI-4 WAS RETURNED TO OMSC. OMSC EVALUATED THE REFERENCED POWER UNIT IN COMBINATION WITH THE UHI-4 OWNED BY OMSC AND FOUND THAT THE FRONT PANEL OF THE UHI-4 WAS NOT FUNCTIONED CORRECTLY. OMSC RETURNED THE POWER UNIT TO THE MANUFACTURER OF THE POWER UNIT FOR FURTHER INVESTIGATION. 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 # 8010047-2018-00557 TO PROVIDE THE DEVICE EVALUATION RESULTS. THE MANUFACTURER OF THE POWER UNIT INVESTIGATED THE POWER UNIT AND FOUND THAT THE CAPACITOR FOR THE POWER UNIT WAS DAMAGED, CONSEQUENTLY THE POWER UNIT COULD NOT OPERATE. FURTHERMORE, THE MANUFACTURER OF THE CAPACITOR CONCLUDED THAT THE CAUSE FOR THE BREAKAGE OF THE CAPACITOR WAS RANDOM FAILURE. OMSC STATED THE COUNTER MEASURES AGAINST ABNORMALITIES OF UHI-4 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 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 UHI-4 DID NOT START UP WHEN THE UHI-4 WAS TURNED POWER ON. (B)(4) EXCHANGED THE POWER UNIT OF THE UHI-4 TO ANOTHER POWER UNIT, THE UHI-4 STARTED UP WITHOUT ANY PROBLEM. 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 LAPAROSCOPIC CHOLECYSTECTOMY, EVEN THOUGH THE FACILITY TURNED ON THE UHI-4, THE UHI-4 COULD NOT START. 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
    231336 HIGH FLOW INSUFFLATION UNIT HIGH FLOW INSUFFLATION UNIT HIF OLYMPUS MEDICAL SYSTEMS CORP. UHI-4

    Patients

    Seq Age Sex Outcome Treatment
    1