BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA III XENON LIGHT SOURCE

    MDR report key: 12382564 · Received August 30, 2021

    Report

    Report Number
    8010047-2021-10929
    Event Type
    Malfunction
    Date Received
    August 30, 2021
    Date of Event
    August 7, 2021
    Report Date
    August 30, 2021
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    NWB
    PMA / PMN Number
    CLASS2-EXMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS PLANNED TO BE RETURNED TO OLYMPUS MEDICAL SYSTEMS (B)(4) PRIVATE LIMITED (B)(4) BUT HAS NOT BEEN RETURNED YET. 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 BY THE USER THAT DURING THE PREPARATION FOR USE, THE SCOPE COMMUNICATION ERROR B30 OCCURRED WHEN THE DEVICE WAS USED WITH AN OLYMPUS 190 SERIES ENDOSCOPE. THE DEVICE WORKED PROPERLY WHEN USED WITH THE OLYMPUS 150 SERIES ENDOSCOPES. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1285307 EVIS EXERA III XENON LIGHT SOURCE XENON LIGHT SOURCE NWB OLYMPUS MEDICAL SYSTEMS CORP. CLV-190

    Patients

    Seq Age Sex Outcome Treatment
    1