BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA III VIDEO SYSTEM CENTER

    MDR report key: 17853662 · Received October 2, 2023

    Report

    Report Number
    3002808148-2023-10625
    Event Type
    Malfunction
    Date Received
    October 2, 2023
    Date of Event
    September 6, 2023
    Report Date
    December 1, 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
    AR, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE RESULTS OF THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. NEW INFORMATION ADDED TO THE FOLLOWING FIELDS: H6. CORRECTED FIELDS: D9 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 NOT POSSIBLE TO ESTABLISH THE ROOT CAUSE. HOWEVER, IT IS LIKELY THE FOLLOWING LED TO THE MALFUNCTION: INCORRECT CONNECTION METHOD BETWEEN THE PERIPHERAL DEVICES AND THE CV-190. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    IN SPEAKING WITH OLYMPUS TECHNICAL ASSISTANCE CENTER (TAC), TAC EXPLAINED THEY NEEDED TO ADDRESS THE E315 ISSUE FIRST. TAC ASKED IF THE KEYBOARD WAS PLUGGED IN INTO THE OPTION OR ADAPTER PORTS BY MISTAKE AND THE OLYMPUS EMPLOYEE SAID NO, IT WAS PLUGGED INTO THE KEYBOARD PORT, BUT THEN STATED THE OLYMPUS EMPLOYEE HAD THE MAJ-1916/MAJ-1918 PLUGGED INTO OPTION 1. TAC INSTRUCTED THE OLYMPUS EMPLOYEE TO MOVE THAT TO THE ADAPTER PORT AND THE E315 WAS RESOLVED. TAC THEN FOCUSED ON CREATING 2 DIFFERENT USER SETTINGS FOR USE WITH THE OEP_6 PRINTER AND THE GGASTRO SYSTEM. THE OLYMPUS EMPLOYEE STATED THE OEP-6 WILL BE ON ITS OWN ROLLING CART AND WILL ONLY BE CONNECTED FOR CERTAIN SITUATIONS AND WHEN IT IS TO BE USED THE CUSTOMER WILL NOT USE THE GGASTO SYSTEM. TAC HAD THE OLYMPUS EMPLOYEE GO TO USER SETTING>EDIT> INPUT AND TOGGLED DOWN TO #2 AND CHANGED NAME FROM "NO DATA" TO "OEP-6¿ THEN TO BASIC SETUP AND SET TARGET DEVICES FOR RELEASE 1 SERVER/MEMORY ON, PRINTER ON, DF DEVICE OFF, AND IMH OFF. FOR THE GGASTRO, THE OLYMPUS EMPLOYEE WENT TO USER SETTING>EDIT> INPUT AND TOGGLED DOWN TO #3 AND CHANGED NAME FROM "NO DATA" TO "GGASTRO". THEN TO BASIC SETUP AND SET TARGET DEVICES FOR RELEASE 1 SERVER/MEMORY ON, PRINTER OFF, DF DEVICE ON, AND IMH OFF. THEN TO ADVANCED SETTINGS> SYSTEM SETUP> PERIPHERALS> PERIPHERAL 2 AND CHANGED PRINTER TYPE TO OEP-5 AND PERIPHERAL 1 AND CHANGED THE D F FILING SYSTEM TYPE TO REMOTE AND VIDEO TO SDI. THE OLYMPUS EMPLOYEE WAS UNABLE TO TEST FURTHER BECAUSE AT THIS TIME THE OLYMPUS EMPLOYEE DID NOT HAVE THE PRINTER OR THE GGASTRO SYSTEM. TAC AGREED TO EMAIL THE OLYMPUS EMPLOYEE THE CASE NUMBER SO THEY CAN FOLLOW UP IF THEY HAVE PROBLEMS. ONCE THEY GET THE PRINTER AND DF SYSTEM HOOKED UP. ON 06 SEPT 2023 THE OLYMPUS EMPLOYEE CALLED TAC AND A SECOND USER ON PROCESSOR TO BE USED WITH PHYSICIAN THAT WANTS TO USE OEP-6 PRINTER WAS SET UP. THE OLYMPUS EMPLOYEE TURNED RELEASE 1 TO PRINTER TO ON IN USER SETTINGS AND SET THE PRINTER TYPE TO REMOTE IN PERIPHERAL SETTINGS ON PROCESSOR. THE OLYMPUS EMPLOYEE PLANNED TO PROCURE AN MAJ-854 REMOTE CABLE AND TERMINATE IT TO MONITO REMOTE 2 ON THE REAR OF THE PROCESSOR AND REMOTE 2 ON THE REAR OF THE PRINTER. THE OLYMPUS EMPLOYEE WILL INSTRUCT THEIR CUSTOMER ON CHANGING USERS ACCORDINGLY. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION OR IF ANY ADDITIONAL INFORMATION IS PROVIDED BY THE USER FACILITY.

    Description of Event or Problem · 0

    THE OLYMPUS EMPLOYEE REPORTED ON BEHALF OF THE CUSTOMER, THE EVIS EXERA III VIDEO SYSTEM CENTER DISPLAYED ERROR CODE E315 (PERIPHERAL CONNECTION ERROR) WHILE SETTING UP THE NEW DEVICE WITH AN EVIS EXERA III XENON LIGHT SOURCE, SCOPE, AND MONITOR TO WORK WITH AN OEP-6. THERE WERE NO REPORTS OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1983041 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.| GGASTRO SYSTEM.| OEP-6.