BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISERA ELITE XENON LIGHT SOURCE

    MDR report key: 11130410 · Received January 7, 2021

    Report

    Report Number
    8010047-2021-01008
    Event Type
    Malfunction
    Date Received
    January 7, 2021
    Date of Event
    May 14, 2020
    Report Date
    January 7, 2021
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    NWB
    PMA / PMN Number
    CLASS2-EXMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT FOR NON-FATAL SERIOUS INJURY/DEVICE MALFUNCTION HAS BEEN STORED UNDER THE COVID-19 PANDEMIC IN ACCORDANCE WITH THE GUIDANCE PUBLISHED BY FDA, POSTMARKETING ADVERSE EVENT REPORTING FOR MEDICAL PRODUCTS AND DIETARY SUPPLEMENTS DURING A PANDEMIC. THE SUBJECT DEVICE WAS RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOR EVALUATION. OMSC COULD NOT DUPLICATE THE REPORTED PHENOMENON WHILE USING IT AS INSTRUCTED, BUT WHEN THE VIDEO SIGNAL CABLE (SDI CABLE) WAS ROUNDED WITH THE OUTPUT CORD OF THE ELECTRIC KNIFE, THE REPORTED PHENOMENON RECURRED. OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) REVIEWED THE MANUFACTURING HISTORY (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 INVESTIGATION, THERE WAS THE POSSIBILITY THAT THE REPORTED PHENOMENON WAS ATTRIBUTED TO THE FAILURE OF VIDEO PROCESSING DUE TO THE INFLUENCE OF HIGH FREQUENCY NOISE CAUSED BY THE ELECTRIC KNIFE OF OTHER COMPANY.

    Description of Event or Problem · 1

    OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED FROM THE USER THAT THE IMAGE WENT OUT SEVERAL TIMES DURING A RESPIRATORY SURGERY WHEN THE SUBJECT DEVICE WAS USED IN CONJUNCTION WITH AN ELECTRIC KNIFE OF OTHER COMPANY. THE USER REPLACED THE VIDEO SYSTEM INCLUDING THE SUBJECT DEVICE WITH ANOTHER ONE. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28361 VISERA ELITE XENON LIGHT SOURCE XENON LIGHT SOURCE NWB OLYMPUS MEDICAL SYSTEMS CORP. CLV-S190

    Patients

    Seq Age Sex Outcome Treatment
    1