BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIGH FLOW INSUFFLATION UNIT

    MDR report key: 6957320 · Received October 18, 2017

    Report

    Report Number
    8010047-2017-01490
    Event Type
    Malfunction
    Date Received
    October 18, 2017
    Date of Event
    September 19, 2017
    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 · 1

    THE REFERENCED UHI-4 WAS RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOR EVALUATION. THE EVALUATION COULD CONFIRM THE USER¿S REPORT AND THE RECORDING ¿ERROR 03¿, ALSO FOUND THAT THE PRESSURE SENSOR OF THE UHI-4 WAS DAMAGED. THEREFORE THE UHI-4 COULD NOT OPERATE PROPERLY, AND IT CAUSED THE INOPERABILITY. THE CAUSE OF THE DAMAGE OF THE PRESSURE SENSOR CANNOT BE CONCLUSIVELY DETERMINED, HOWEVER THERE WAS THE POSSIBILITY THAT THE PRESSURE SENSOR BROKE ACCIDENTALLY. 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 · 1

    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 BEIJING (OSH). OSH EVALUATED THE UHI-4 AND FOUND THAT THERE WAS NO DAMAGE ON THE EXTERIOR APPEARANCE OF THE UHI-4, HOWEVER THE UHI-4 DID NOT START UP WHEN THE UHI-4 WAS TURNED POWER ON. OSH EXCHANGED THE MAIN CIRCUIT BOARD OF THE UHI-4 TO ANOTHER MAIN CIRCUIT BOARD, 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 PREPARATION OF THE LAPAROSCOPIC CHOLECYSTECTOMY, THE UHI-4 COULD NOT OPERATE. THE PATIENT WAS ALREADY UNDER ANESTHESIA. 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
    737903 HIGH FLOW INSUFFLATION UNIT HIGH FLOW INSUFFLATION UNIT HIF OLYMPUS MEDICAL SYSTEMS CORP. UHI-4

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR