BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA III VIDEO SYSTEM CENTER

    MDR report key: 10807821 · Received November 9, 2020

    Report

    Report Number
    8010047-2020-08687
    Event Type
    Malfunction
    Date Received
    November 9, 2020
    Date of Event
    October 12, 2020
    Report Date
    December 18, 2020
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FET
    PMA / PMN Number
    K131780
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION. THE DEVICE HAS NOT BEEN RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) BUT WAS RETURNED TO THE SERVICE DEPARTMENT OF OLYMPUS AUSTRALIA & NEW ZEALAND (OAZ) FOR EVALUATION. THE EVALUATION OF THE DEVICE BY OAZ CONFIRMED THE FOLLOWING; -WHEN THE SCOPE CONNECTOR OF THE ENDOSCOPE WAS OPERATED, THE ENDOSCOPIC IMAGE WAS FLICKERING. -WHEN THE DEVICE WAS USED WITH OLYMPUS 180 SERIES AND 190 SERIES VIDEOSCOPES, THE REPORTED EVENT THAT NO ENDOSCOPIC IMAGE WAS DISPLAYED COULD NOT BE REPRODUCED. -DUST WAS PILING UP ON THE REAR PANEL CONNECTORS AND THE VIDEO CONNECTOR SOCKET OF THE FRONT PANEL AND INSIDE THE DEVICE. -THE VIDEO CONNECTOR SOCKET HAD SIGNS OF CORROSION. FROM THE EVALUATION OF THE DEVICE BY QAZ, OMSC CONCLUDED THAT NO ENDOSCOPIC IMAGE WAS DISPLAYED MAY HAVE BEEN CAUSED BY THE FOLLOWING; -THERE WAS NO PROBLEM WITH THE DEVICE, AND THERE WAS A PROBLEM WITH OTHER THAN THE DEVICE (ENDOSCOPE, SCOPE CABLE, LIGHT SOURCE, DIGITAL LIGHT SOURCE CABLE). -THE ELECTRICAL CONTACTS OF THE VIDEO CONNECTOR WERE WORN DUE TO DETERIORATION OVER TIME, AND POOR CONTACT OCCURRED AND THE VIDEO SIGNAL COULD NOT BE TRANSMITTED. AND THE PHENOMENON THAT THE ENDOSCOPIC IMAGE WAS FLICKERING APPEARED TO BE CAUSED BY THE INSTABILITY OF THE ELECTRICAL CONTACTS DUE TO DUST AND CORROSION OF THE DEVICE AND THE VIDEO SIGNAL COULD NOT BE TRANSMITTED. OMSC CONCLUDED THAT THE DUST ON THE DEVICE WAS CAUSED BY THE USER USING IT IN A DUSTY ENVIRONMENT AND NOT CLEANING IT FREQUENTLY. AND THERE IS POSSIBILITY THAT THE CORROSION OF THE VIDEO CONNECTOR SOCKET WAS CAUSED BY REPEATED USE FOR A LONG PERIOD OF TIME, OR BY THE USER CONNECTING THE ELECTRICAL CONTACTS OF THE VIDEO CONNECTOR WITHOUT DRYING SUFFICIENTLY. OMSC COULD NOT CONFIRM DEVICE HISTORY RECORD (DHR) BECAUSE DHR WAS NOT AVAILABLE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED.

    Additional Manufacturer Narrative · 1

    THE DEVICE IN THIS REPORT HAS NOT BEEN RETURNED TO OMSC FOR EVALUATION. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED.

    Description of Event or Problem · 1

    OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED THAT DURING PREPARATION FOR USE, NO ENDOSCOPIC IMAGE WAS DISPLAYED. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1278409 EVIS EXERA III VIDEO SYSTEM CENTER VIDEO SYSTEM CENTER FET OLYMPUS MEDICAL SYSTEMS CORP. CV-190

    Patients

    Seq Age Sex Outcome Treatment
    1