BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA III VIDEO SYSTEM CENTER

    MDR report key: 15866740 · Received November 25, 2022

    Report

    Report Number
    3002808148-2022-04590
    Event Type
    Malfunction
    Date Received
    November 25, 2022
    Date of Event
    October 31, 2022
    Report Date
    January 13, 2023
    Manufacturer
    SHIRAKAWA OLYMPUS CO., LTD.
    Product Code
    FET
    UDI-DI
    04953170298622
    PMA / PMN Number
    K131780
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    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 DEFINITIVE ROOT CAUSE OF THE FAULTY PATIENT BOARD SET COULD NOT BE DETERMINED. ACCORDING TO THE SERVICE MANUAL, THE PATIENT CIRCUIT BOARD HAS SCOPE CONTROL, IMAGE DATA TRANSMISSION, AND VIDEO SIGNAL PROCESSING FUNCTIONS. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED FOR INVESTIGATION. UPON EVALUATION OF THE DEVICE, THE REPORTED ISSUE WAS CONFIRMED DUE TO A FAULTY PATIENT BOARD SET. IN ADDITION, WORN-OUT VIDEO CONNECTOR LATCH CAUSING POOR CONNECTION WITH PIGTAILS AND A REAR PANEL DAMAGE WERE OBSERVED. THE INVESTIGATION IS ONGOING; THEREFORE, THE ROOT CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED AT THIS TIME, HOWEVER, IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED ACCORDINGLY.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THE EVIS EXERA III VIDEO SYSTEM CENTER FAILS TO RECOGNIZE VIDEO CABLES WITH THE 180 SCOPES. THE EVENT OCCURRED DURING PREPARATION FOR USE AND THERE WAS NO PATIENT HARM OR USER INJURY REPORTED DUE TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2430263 EVIS EXERA III VIDEO SYSTEM CENTER VIDEO SYSTEM CENTER FET SHIRAKAWA OLYMPUS CO., LTD. CV-190 04953170298622

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown UNSPECIFIED 180 SERIES SCOPE