BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA III XENON LIGHT SOURCE

    MDR report key: 11152946 · Received January 11, 2021

    Report

    Report Number
    8010047-2021-01205
    Event Type
    Malfunction
    Date Received
    January 11, 2021
    Report Date
    March 19, 2021
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    NWB
    PMA / PMN Number
    CLASS2-EXMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION. THE SUBJECT DEVICE WAS NOT RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOR EVALUATION. OMSC REVIEWED THE MANUFACTURE HISTORY (DHR) OF THE SUBJECT DEVICE AND CONFIRMED NO IRREGULARITY. THE EXACT CAUSE OF THE REPORTED PHENOMENON COULD NOT BE CONCLUSIVELY DETERMINED. HOWEVER, THERE WAS THE POSSIBILITY THAT THE REPORTED PHENOMENON WAS ATTRIBUTED TO UNSTABLE ELECTRICAL CONTACTS OF THE CONNECTOR RESULTING IN HINDERED IMAGE TRANSMISSION BETWEEN THE SCOPE AND THE VIDEO PROCESSOR. THE UNSTABLE ELECTRICAL CONTACTS COULD HAVE OCCURRED DUE TO THE FOLLOWING CAUSES: THE LOCK AND PIN OF THE VIDEO CONNECTOR WORN OUT DUE TO REPEATED USE FOR A LONG PERIOD OF TIME. THE CONNECTOR LOCK HAD FAILURE DUE TO EXTERNAL FORCES. THE CONNECTOR WAS CORRODED DUE TO RESIDUAL FOREIGN MATERIALS. THE INSTRUCTION MANUAL INSTRUCTS AS FOLLOWS; "BEFORE CONNECTING THE ENDOSCOPE CONNECTOR TO THE LIGHT SOURCE, CONFIRM THAT THE ENDOSCOPE CONNECTOR, INCLUDING THE ELECTRICAL CONTACTS ARE COMPLETELY DRY AND CLEAN. IF THE ENDOSCOPE IS USED WITH THE ELECTRICAL CONTACTS WET AND/OR DIRTY, THE ENDOSCOPE AND LIGHT SOURCE MAY MALFUNCTION." "DO NOT CLEAN THE OUTPUT SOCKET, OTHER CONNECTORS, OR THE AC POWER INLET. CLEANING THEM CAN DEFORM OR CORRODE THE CONTACTS RESULTING IN DAMAGE TO THE LIGHT SOURCE."

    Additional Manufacturer Narrative · 1

    SINCE THE SUBJECT DEVICE HAS BEEN NOT RETURNED TO OMSC FOR THE 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 FROM THE USER THAT THE IMAGE OF THE SUBJECT DEVICE WAS FLICKER AND INTERMITTENT DURING THE UNSPECIFIED PROCEDURE. THE INTENDED PROCEDURE WAS COMPLETED USING THE SAME SET OF EQUIPMENT. THE USER ALSO REPORTED THAT THIS PHENOMENON WAS OCCURRED TO THE SUBJECT DEVICE IN COMBINATION WITH ANY KIND OF ENDOSCOPES. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    42128 EVIS EXERA III XENON LIGHT SOURCE XENON LIGHT SOURCE NWB OLYMPUS MEDICAL SYSTEMS CORP. CLV-190

    Patients

    Seq Age Sex Outcome Treatment
    1