BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISERA ELITE II VIDEO SYSTEM CENTER

    MDR report key: 10294247 · Received July 20, 2020

    Report

    Report Number
    8010047-2020-04591
    Event Type
    Malfunction
    Date Received
    July 20, 2020
    Date of Event
    June 17, 2020
    Report Date
    December 23, 2020
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FET
    PMA / PMN Number
    K193026
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION. OMSC INVESTIGATED THE DEVICE, HOWEVER FOUND NO ANOMALIES. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED, HOWEVER THERE IS POSSIBILITY THAT THE REPORTED EVENT WAS CAUSED BY THE FOLLOWING; THE DX BOARD THAT GENERATES 3D VIDEO SIGNALS AND SWITCHES BETWEEN 2D AND 3D IMAGES MALFUNCTIONED TEMPORARILY DUE TO THE INFLUENCE OF THE USAGE ENVIRONMENT SUCH AS POWER SUPPLY NOISE, DISTURBANCE NOISE, OR ETC., CAUSING AN ERROR OCCURRED WHEN SWITCHING BETWEEN 2D AND 3D IMAGES. THE ENDOSCOPE CONNECTED TO THE DEVICE HAD FAILED. DEVICE HISTORY RECORD (DHR) REVIEW INDICATES THAT THE PRODUCT WAS MANUFACTURED AND TESTED IN ACCORDANCE WITH ALL APPLICABLE PROCEDURES AND MET ALL FINAL PRODUCT RELEASE CRITERIA. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED.

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE WAS RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOR EVALUATION. IN THE EVALUATION OF OMSC THE FOLLOWING WAS CONFIRMED; NO ABNORMALITIES WERE NOTED IN THE APPEARANCE OF THE SUBJECT DEVICE. OMSC COULD NOT REPRODUCE THE REPORTED PHENOMENON WHICH WAS THAT 3D ENDOSCOPIC IMAGE WAS NOT DISPLAYED. 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

    DURING AN INSPECTION OF THE SUBJECT DEVICE BEFORE A UNSPECIFIED PROCEDURE, 3D ENDOSCOPIC IMAGE WAS NOT DISPLAYED. THE SUBJECT DEVICE WAS USED WITH A OLYMPUS 3D DEFLECTABLE VIDEOSCOPE LTF-S300-10-3D, A SONY MONITOR LMD-X310ST. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    758578 VISERA ELITE II VIDEO SYSTEM CENTER VIDEO SYSTEM CENTER FET OLYMPUS MEDICAL SYSTEMS CORP. OTV-S300

    Patients

    Seq Age Sex Outcome Treatment
    1