BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA III XENON LIGHT SOURCE

    MDR report key: 11122330 · Received January 6, 2021

    Report

    Report Number
    8010047-2021-00922
    Event Type
    Malfunction
    Date Received
    January 6, 2021
    Report Date
    March 11, 2021
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    NWB
    PMA / PMN Number
    CLASS2-EXMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION. THE SUBJECT DEVICE HAS NOT BEEN RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOR EVALUATION. OMSC REVIEWED THE MANUFACTURING HISTORY (DHR) OF THE SUBJECT DEVICE AND CONFIRMED NO IRREGULARITY. MORE THAN FOUR YEARS HAVE PASSED SINCE THE SUBJECT DEVICE WAS MANUFACTURED. NO IMAGE ON THE EVIS 180 SERIES COULD HAVE BEEN ATTRIBUTED TO OTHER DEVICES THAN THE SUBJECT DEVICE, AS THE SUBJECT DEVICE DOES NOT HAVE THE IMAGE PROCESSING FUNCTION WITH EVIS 180 SERIES VIDEOSCOPES. THE ERROR B30 AND NO IMAGE WITH EVIS 190 SERIES COULD HAVE BEEN ATTRIBUTED TO COMMUNICATION ERROR DUE TO THE ELECTRICAL CONTACTS FAILURE OF THE CONNECTOR AND/OR THE VIDEO SIGNAL PROCESSING FAILURE OF THE ELECTRICAL BOARD.

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE HAS NOT BEEN RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOR EVALUATION. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED AT THIS TIME. IF ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE SUPPLEMENTED.

    Description of Event or Problem · 1

    OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED FROM THE USER THAT THE IMAGE WAS NOT DISPLAYED AND THE SCOPE COMMUNICATION ERROR B30 WAS DISPLAYED DURING AN UNSPECIFIED PROCEDURE USING THE SUBJECT DEVICE AND EVIS 190/180 SERIES VIDEOSCOPE. THERE WAS NO PATIENT INJURY ASSOCIATED WITH THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    22155 EVIS EXERA III XENON LIGHT SOURCE XENON LIGHT SOURCE NWB OLYMPUS MEDICAL SYSTEMS CORP. CLV-190

    Patients

    Seq Age Sex Outcome Treatment
    1