BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS LUCERA ELITE XENON LIGHT SOURCE

    MDR report key: 10060072 · Received May 14, 2020

    Report

    Report Number
    8010047-2020-02710
    Event Type
    Malfunction
    Date Received
    May 14, 2020
    Date of Event
    April 22, 2020
    Report Date
    November 23, 2020
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    GCT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION. THE SUBJECT DEVICE WAS NOT RETURNED TO THE OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOR EVALUATION. OMSC REVIEWED THE MANUFACTURE HISTORY (DHR) OF THE DEVICE AND CONFIRMED NO IRREGULARITY. THE EXACT CAUSE OF THE REPORTED PHENOMENON COULD NOT BE CONCLUSIVELY DETERMINED. HOWEVER, THERE WAS THE POSSIBILITY THAT THIS PHENOMENON WAS ATTRIBUTED TO THE DISTORTION OF THE TURRET OR THE DAMAGE OF THE SENSOR OF THE TURRET WHICH WAS CAUSED POSSIBILITY BY THAT THE EXCESSIVE FORCE WAS APPLIED TO THE TURRET OR AROUND THE TURRET OF THE SUBJECT DEVICE.

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE DEVICE EVALUATION RESULT AND CORRECT IN THE INITIAL REPORT SUBMITTED ON MAY 15, 2020. THE SUBJECT DEVICE HAS NOT BEEN RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOR EVALUATION. HOWEVER, BASED ON THE INFORMATION FROM OLYMPUS TRADING SHANGHAI LIMITED, OMSC CONCLUDED THAT THE REPORTED EVENT WAS NOT REPORTABLE EVENT.

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE IN THIS REPORT HAS NOT BEEN RETURNED TO OMSC FOR 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 THAT THE CONTROL PANEL OF THE SUBJECT DEVICE BLINKED AND A CLV TURRET ERROR E200 OCCURRED. THE SUBJECT DEVICE HAS NOT BEEN RETURNED TO OMSC BUT WAS RETURNED TO OLYMPUS TRADING SHANGHAI LIMITED. (OSH). IN THE EVALUATION OF OSH. THE FOLLOWING WAS CONFIRMED, THERE WAS NO ABNORMALITY OF THE EXTERIOR OF THE SUBJECT DEVICE, ALSO INSIDE OF THE SUBJECT DEVICE SUCH AS THE EVIDENCE OF THE INVASION OF WATER. THE ROTATION OF THE RED, GREEN AND BLUE (RGB) FILTER UNIT WAS ABNORMAL, AND THE BUTTONS ON THE FRONT PANEL WERE FLASHED. HOWEVER THE RGB FILTER UNIT WAS REPLACED TO ANOTHER ONE, THEN THE SUBJECT DEVICE WORKED PROPERLY WITHOUT BLINKING OF THE FRONT PANEL AND OCCURRING THE ERROR E200. THERE WAS NO DAMAGE OF THE RGB FILTER UNIT. OTHER DETAILED INFORMATION WAS NOT PROVIDED. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    519511 EVIS LUCERA ELITE XENON LIGHT SOURCE XENON LIGHT SOURCE GCT OLYMPUS MEDICAL SYSTEMS CORP. CLV-290SL

    Patients

    Seq Age Sex Outcome Treatment
    1