BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA III XENON LIGHT SOURCE

    MDR report key: 11580267 · Received March 28, 2021

    Report

    Report Number
    8010047-2021-04232
    Event Type
    Malfunction
    Date Received
    March 28, 2021
    Report Date
    April 26, 2021
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    NWB
    PMA / PMN Number
    CLASS2-EXMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE SUBJECT DEVICE EVALUATION RESULT. THE SUBJECT DEVICE WAS NOT RETURNED TO ANY OF OLYMPUS LOCATIONS FOR EVALUATION. OMSC REVIEWED THE DEVICE HISTORY RECORD (DHR) OF THE SUBJECT DEVICE AND CONFIRMED NO IRREGULARITY. THE EXACT CAUSE OF THE REPORTED PHENOMENON COULD NOT BE CONCLUSIVELY DETERMINED. HOWEVER, BASED UPON THE INFORMATION THAT THE SUBJECT DEVICE WAS NOT RETURNED THE OLYMPUS AND THE PHENOMENA (ERRORS B30 AND E216 OCCURRED) OCCURRED ON THE TWO LIGHT SOURCES, THERE WAS THE POSSIBILITY THAT THE SUBJECT DEVICE HAD NO PROBLEM, THESE PHENOMENA MIGHT BE ATTRIBUTED TO THE MALFUNCTION OF OTHER THAN THE SUBJECT DEVICE (THE ENDOSCOPE, THE VIDEO PROCESSOR OR THE LIGHT SOURCE CABLE).

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE WAS NOT RETURNED TO ANY OF OLYMPUS LOCATIONS. THEREFORE, OLYMPUS COULD NOT INVESTIGATE THE SUBJECT DEVICE. 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 DURING UNSPECIFIED TIMING, IT WAS FOUND THAT THE SCOPE COMMUNICATION ERROR B30 AND E216 WERE DISPLAYED WHILE THE EVIS 190/185 SERIES VIDEOSCOPE WAS CONNECTED. THE USER CLEANED THE ELECTRICAL CONTACTS OF THE ENDOSCOPE AND THE OUTPUT SOCKET OF THE SUBJECT DEVICE WITH THE LIGHT SOURCE SOCKET CLEANING KIT, BUT THE ISSUE COULD NOT BE RESOLVED COMPLETELY. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    477455 EVIS EXERA III XENON LIGHT SOURCE XENON LIGHT SOURCE NWB OLYMPUS MEDICAL SYSTEMS CORP. CLV-190

    Patients

    Seq Age Sex Outcome Treatment
    1