BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA III VIDEO SYSTEM CENTER

    MDR report key: 17018792 · Received May 30, 2023

    Report

    Report Number
    3002808148-2023-05370
    Event Type
    Malfunction
    Date Received
    May 30, 2023
    Date of Event
    May 1, 2023
    Report Date
    June 28, 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
    WA, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. DURING CUSTOMER'S TESTING, THEY DETERMINED THE COMMUNICATION ERROR WAS CAUSED BY THE ATTACHED SCOPE AND NOT THE EVIS EXERA III VIDEO SYSTEM CENTER. THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF INVESTIGATION.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION OBTAINED FROM THE CUSTOMER AND RESULTS THE APPROVED FINAL INVESTIGATION. CORRECTION TO D10 FOR CONCOMITANT PRODUCT CODE, AND H10 FOR CUSTOMER INFORMATION INADVERTENTLY LEFT OUT OF INITIAL. THE CUSTOMER DETERMINED THE ATTACHED SCOPE WAS THE CAUSE OF THE ISSUE. THE SCOPE WAS RETURNED FOR SERVICE (SERIAL NUMBER 2840353); TESTING SHOWED THE SCOPE WAS FOUND TO HAVE AN IMAGE RELAY PROBLEM. INSPECTION OF THE SCOPE SHOWED FLUID INGRESSION. THE CONNECTOR AND BODY CONTROL UNIT WERE OPENED, HEAT DRIED AND REASSEMBLED. AFTER REASSEMBLY, THE DEVICE RELAYED AN IMAGE AS EXPECTED. 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, IT IS LIKELY THE PHENOMENON OCCURRED DUE TO THE SCOPE. THERE WAS NO MALFUNCTION WITH THE SUBJECT DEVICE. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THE EVIS EXERA III VIDEO SYSTEM CENTER WAS IN USE WITH A CLV-190 SCOPE AND AN "ERROR B30" OCCURRED. THIS MESSAGE INDICATES A SCOPE COMMUNICATION ERROR. THE CUSTOMER REPORTED THE ISSUE OCCURRED DURING PREPARATION PRIOR TO USE. NO ADVERSE EFFECTS TO PATIENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1617703 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 CLV-190.| PCF-H190DL.