BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA III VIDEO SYSTEM CENTER

    MDR report key: 15921325 · Received December 5, 2022

    Report

    Report Number
    3002808148-2022-04876
    Event Type
    Malfunction
    Date Received
    December 5, 2022
    Date of Event
    November 9, 2022
    Report Date
    January 12, 2023
    Manufacturer
    SHIRAKAWA OLYMPUS CO., LTD.
    Product Code
    NWB
    UDI-DI
    04953170298622
    PMA / PMN Number
    K131780
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, 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 APPROVED 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, AND SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION, THE DEFINITIVE ROOT CAUSE OF THE IMAGE ISSUE COULD NOT BE DETERMINED. IT IS POSSIBLE THAT THE IMAGE FAILURE OCCURRED DUE TO INCORRECT VIDEO CABLE CONNECTION OR VIDEO INPUT SETTINGS. THE INSTRUCTION MANUAL VERBIAGE IN "CHAPTER 3.6: CONNECTION OF THE MONITOR OF THE INSTRUCTION MANUAL" DESCRIBES HOW TO CONNECT THE VIDEO CABLE, WHICH MAY HAVE PREVENTED THE PHENOMENON. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    OLYMPUS TECHNICAL ASSISTANCE CENTER (TAC) SUPPORT SPOKE TO THE CUSTOMER TO TROUBLESHOOT THE DEVICE. TAC INSTRUCTED THE CUSTOMER TO MOVE COMP OUT ON THE CV-190 TO SERIAL DIGITAL INTERFACE (SDI) AND IMAGE WAS OBTAINED ON THE ENDOPRO. TAC ASKED THE CUSTOMER TO PRESS CONTROL/DISPLAY ON THE OEV-262H, PRESS PORT A, SELECT SDI, AND IMAGE WAS OBTAINED ON THE OEV-262H. 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 DISPLAY IMAGE ON THE OEV-262H; HOWEVER, NO IMAGE WAS OBTAINED ON THE ENDOPRO SOFTWARE. THE CUSTOMER ATTEMPTED THREE DIFFERENT CV-190¿S BUT THE ISSUE PERSISTED. 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
    1958927 EVIS EXERA III VIDEO SYSTEM CENTER ENDOSCOPIC VIDEO IMAGE PROCESSING UNIT NWB SHIRAKAWA OLYMPUS CO., LTD. CV-190 04953170298622

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown OEV-262H