BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIGH FLOW INSUFFLATION UNIT

    MDR report key: 12864770 · Received November 23, 2021

    Report

    Report Number
    8010047-2021-14952
    Event Type
    Malfunction
    Date Received
    November 23, 2021
    Report Date
    January 3, 2022
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    HIF
    UDI-DI
    04953170324147
    PMA / PMN Number
    K122180
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. BASED ON THE RESULTS OF THE INVESTIGATION, THE CAUSE OF THE DEVICE LOSING POWER OCCURRED FROM A POWER OUTAGE AT THE FACILITY. THE INVESTIGATION CONFIRMED NO DEVICE MALFUNCTION OCCURRED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    THE DEVICE REFERENCED IN THIS REPORT WAS NOT RETURNED TO OLYMPUS FOR EVALUATION. THE DEFINITIVE CAUSE OF THE USER'S EXPERIENCE CANNOT BE DETERMINED AT THIS TIME. THE INVESTIGATION IS ONGOING. THIS REPORT WILL BE UPDATED UPON COMPLETION OF THE INVESTIGATION OR UPON RECEIPT OF ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTS DURING A BRONCHOSCOPY; MEDIASTINOSCOPY; ROBOTIC ASSISTED RIGHT UPPER LOBE (RUL) LOBECTOMY PROCEDURE USING A HIGH FLOW INSUFFLATION UNIT WITH A DAVINCI XI ROBOT, A MAJOR POWER OUTAGE WAS EXPERIENCED DURING THE PROCEDURE, CAUSING THE INSUFFLATION UNIT TO POWER OFF. THE PHYSICIAN WAS DISPLEASED WHEN THE POWER WAS RESTORED, AND THE SETTINGS WERE DIFFERENT THAN HE EXPECTED. THE PATIENT DID EXPERIENCE A DROP IN BLOOD PRESSURE, BUT THIS WAS CORRECTED WHEN THE INSUFFLATOR TUBING WAS DISCONNECTED. NO INTERVENTION WAS REQUIRED AS THE PATIENT STABILIZED AFTER THE INCREASED CHEST PRESSURE WAS RELIEVED. THE PROCEDURE WAS COMPLETED AS INTENDED ONCE EQUIPMENT WAS INTERROGATED AND RESTARTED. THE PATIENT¿S CURRENT CONDITION IS DISCHARGED FROM FACILITY AND RECOVERING AT HOME WITH NO ADDITIONAL CONSEQUENCES REPORTED. THE BIOMEDICAL ENGINEER AT THE FACILITY REPORTED BOTH THE DAVINCI ROBOT AND INSUFFLATION DEVICE WERE EVALUATED AND NO PROBLEMS WERE FOUND WITH EITHER DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1758269 HIGH FLOW INSUFFLATION UNIT HIGH FLOW INSUFFLATION UNIT HIF OLYMPUS MEDICAL SYSTEMS CORP. UHI-4 04953170324147

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Male DAVINCI ROBOT, SN: (B)(4)