BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIGH FLOW INSUFFLATION UNIT

    MDR report key: 16358314 · Received February 10, 2023

    Report

    Report Number
    3002808148-2023-01305
    Event Type
    Malfunction
    Date Received
    February 10, 2023
    Date of Event
    January 5, 2023
    Report Date
    March 23, 2023
    Manufacturer
    SHIRAKAWA OLYMPUS CO., LTD.
    Product Code
    HIF
    UDI-DI
    04953170324147
    PMA / PMN Number
    K122180
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED AND EVALUATED, AND THE CUSTOMER¿S ALLEGATION WAS CONFIRMED DUE TO A MAIN BOARD FAILURE. THE INVESTIGATION IS ONGOING, AND A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION OR IF ANY ADDITIONAL INFORMATION IS PROVIDED BY THE USER FACILITY. THE FOLLOWING IS THE COMPLETE INFORMATION FOR THE RESPECTIVE FIELD DUE TO CHARACTER MAXIMUM RESTRICTIONS: CONCOMITANT MEDICAL DEVICES: OTV-S300(B)(4), CLV-S200-IR(B)(4), WM-NP2(B)(4)

    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. IT HAS BEEN 4 YEARS SINCE THE SUBJECT DEVICE WAS MANUFACTURED. BASED ON THE RESULTS OF THE INVESTIGATION, IT IS CONFIRMED THAT ALL THE LEDS HAVE TURNED OFF (BLACKED OUT) DUE TO THE FAILURE OF THE MAIN BOARD. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    A DISTRIBUTOR REPORTED TO OLYMPUS THAT THE LIGHT-EMITTING DIODE (LED) LIGHTS ON THE FRONT PANEL OF THE HIGH FLOW INSUFFLATION UNIT TURN OFF 2 TO 3 TIMES EVERY 3 HOURS. THERE WAS NO HEALTH DAMAGE OR SUSPECTED HEALTH DAMAGE. THE DEVICE WAS INSPECTED BEFORE USE. THE INTENDED PROCEDURE WAS A THERAPEUTIC LAPAROSCOPIC LIVER SEGMENTECTOMY. THE PROCEDURE WAS COMPLETED WITH A REPLACEMENT DEVICE. THERE WAS A MINIMAL PROCEDURAL DELAY TO REPLACE THE EQUIPMENT. NO FURTHER DETAILS WERE PROVIDED REGARDING THE PROCEDURE. NO IMAGES OF THE DEFECT WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    47750 HIGH FLOW INSUFFLATION UNIT HIGH FLOW INSUFFLATION UNIT HIF SHIRAKAWA OLYMPUS CO., LTD. UHI-4 04953170324147

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown OTV-S300, CLV-S200-IR, WM-NP2