BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIGH FLOW INSUFFLATION UNIT

    MDR report key: 11285078 · Received February 5, 2021

    Report

    Report Number
    8010047-2021-02276
    Event Type
    Malfunction
    Date Received
    February 5, 2021
    Date of Event
    January 12, 2021
    Report Date
    March 22, 2021
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    HIF
    PMA / PMN Number
    K122180
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION.THE SUBJECT DEVICE WAS NOT RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOR EVALUATION. OMSC REVIEWED THE MANUFACTURING HISTORY (DHR) OF THE SUBJECT DEVICE AND CONFIRMED NO IRREGULARITY.THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED. HOWEVER, BASED UPON THE DEVICE INSPECTION RESULTS BY THE SERVICE DEPARTMENT OF OLYMPUS CHINA, THERE WAS THE POSSIBILITY THAT THE REPORTED PHENOMENON WAS ATTRIBUTED TO THE FAILURE OF THE PRESSURE SENSOR MOUNTED ON THE MAIN BOARD. THE CAUSE OF THE FAILURE OF THE PRESSURE SENSOR MOUNTED ON THE MAIN BOARD IS PRESUMED TO BE DUE TO ANY OF THE FOLLOWING PROCESS ERRORS. OXYGEN ENTERED THE DEVICE AND THE ELECTRODE OF THE PRESSURE SENSOR WAS OXIDIZED AND CORRODED. THE WIRING INSIDE THE PRESSURE SENSOR WAS PEELED OFF DUE TO THE OXIDATION CORROSION. BECAUSE FOREIGN MATTER HAD ADHERED TO THE MOUNTING OF THE COMPONENT DUE TO A MISTAKE, THE WIRES INSIDE THE PRESSURE-SENSOR HAD PEELED OFF DUE TO ADHERENCE OF THE FOREIGN MATTER FAILURE OF THE PRESSURE SENSOR MOUNTED ON THE MAIN BOARD.

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE HAS NOT BEEN RETURNED TO OMSC FOR EVALUATION. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED AT THIS TIME. IF ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE SUPPLEMENTED.

    Description of Event or Problem · 1

    OLYMPUS MEDICAL SYSTEMS CORPORATION (OMSC) WAS INFORMED FROM THE FACILITY THAT WHEN THE SUBJECT DEVICE WAS TURNED ON THE INDICATORS ON THE FRONT PANEL OF THE SUBJECT DEVICE WERE NOT LIT UP DURING PREPARATION FOR A LAPAROSCOPIC SURGERY PROCEDURE. THE USER FACILITY REPLACED THE SUBJECT DEVICE WITH ANOTHER DEVICE AND COMPLETED THE INTENDED PROCEDURE. THE SERVICE DEPARTMENT OF OLYMPUS (B)(4) CHECKED THE SUBJECT DEVICE AND FOUND THAT THE REPORTED PHENOMENON COULD NOT BE DUPLICATED, BUT THE SUBJECT DEVICE COULD NOT BE TURNED ON DUE TO THE FAILURE OF THE MAIN CIRCUIT BOARD. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    181225 HIGH FLOW INSUFFLATION UNIT HIGH FLOW INSUFFLATION UNIT HIF OLYMPUS MEDICAL SYSTEMS CORP. UHI-4

    Patients

    Seq Age Sex Outcome Treatment
    1