BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISERA ELITE II VIDEO SYSTEM CENTER

    MDR report key: 10767555 · Received October 31, 2020

    Report

    Report Number
    8010047-2020-08368
    Event Type
    Malfunction
    Date Received
    October 31, 2020
    Date of Event
    October 5, 2020
    Report Date
    January 12, 2021
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FET
    PMA / PMN Number
    K201200
    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. THE SUBJECT DEVICE WAS RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOR EVALUATION. THE EVALUATION CONFIRMED THE REPORTED PHENOMENON. OMSC REVIEWED THE MANUFACTURE HISTORY (DHR) OF THE SUBJECT DEVICE AND CONFIRMED NO IRREGULARITY. THE EXACT CAUSE OF THE REPORTED PHENOMENON COULD NOT BE CONCLUSIVELY DETERMINED. HOWEVER, THERE WAS POSSIBILITY THAT THE REPORTED PHENOMENON WAS ATTRIBUTED TO ACCIDENTAL FAILURE OF A SUBSTRATE SUCH AS STATIC ELECTRICITY.

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE WAS RETURNED TO OMSC FOR EVALUATION. OMSC EVALUATED THE SUBJECT DEVICE AND FOUND THAT THE REPORTED PHENOMENON WAS DUPLICATED AND THERE WAS NO ABNORMALITY ON THE EXTERIOR OF THE SUBJECT DEVICE. THE EXACT CAUSE HAS BEEN UNDER INVESTIGATION, THEREFORE 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 IMAGE FROM THE HD-SDI OUT 1 TERMINAL OF THE SUBJECT DEVICE WAS NOT DISPLAYED AT THE TIME OF DELIVERY. THERE WAS NO PATIENT INJURY ASSOCIATED WITH THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1232327 VISERA ELITE II VIDEO SYSTEM CENTER VIDEO SYSTEM CENTER FET OLYMPUS MEDICAL SYSTEMS CORP. OTV-S300

    Patients

    Seq Age Sex Outcome Treatment
    1