BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISERA ELITE II VIDEO SYSTEM CENTER

    MDR report key: 13509407 · Received February 10, 2022

    Report

    Report Number
    8010047-2022-02771
    Event Type
    Malfunction
    Date Received
    February 10, 2022
    Date of Event
    January 7, 2022
    Report Date
    May 26, 2022
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FET
    UDI-DI
    04953170386077
    PMA / PMN Number
    K202646
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE SUBJECT DEVICE WAS EVALUATED. THE RETURNED EQUIPMENT WAS OTV-S300 AND THE SERIAL NUMBER WAS (B)(4). DEVICE INSPECTION THE FOLLOWING FINDINGS WERE NOTED. VISUAL INSPECTION: NO ABNORMALITY WAS CONFIRMED. ACTUAL DEVICE CONFIRMATION: IT WAS CONFIRMED THAT NO VIDEO WAS OUTPUT FROM THE HD-SDI TERMINAL. OPERATION CHECK: ABNORMAL NOISE DURING WHITE BALANCE, NBI MALFUNCTION, AND ABNORMAL FAN SPEED WERE CONFIRMED. INVESTIGATION IS ONGOING. THIS REPORT WILL BE SUPPLEMENTED ACCORDINGLY FOLLOWING INVESTIGATION.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE APPROVED FINAL INVESTIGATION. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. BASED ON THE RESULTS OF THE INVESTIGATION, THE DEFINITIVE ROOT CAUSE OF THE ABNORMAL FAN SPEED COULD NOT BE DETERMINED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    CORRECTION TO G3 OF THE INITIAL MEDWATCH. THE AWARE DATE SHOULD BE (B)(6) 2022. INVESTIGATION ACTIVITIES HAVE BEEN OPENED TO MANAGE THE ACTIONS RELATED TO THIS REPORT AND ANY REQUIRED MDR REPORTING.

    Description of Event or Problem · 0

    AS REPORTED, THE NEW OTV-S300 DEVICE FOUND NO VIDEO OUTPUT FROM THE HD-SDI TERMINAL. THE HD-SDI VIDEO OUTPUT DESTINATION DEVICE IS OEP-6. THE ISSUE FOUND DURING DELIVERY , RECEIPT INSPECTION. THERE IS NO PATIENT INVOLVEMENT ASSOCIATED ON THIS EVENT. DEVICE EVALUATION FOUND ABNORMAL FAN SPEED. THIS REPORT IS BEING SUBMITTED FOR ABNORMAL FAN SPEED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1909223 VISERA ELITE II VIDEO SYSTEM CENTER VIDEO SYSTEM CENTER FET OLYMPUS MEDICAL SYSTEMS CORP. OTV-S300 04953170386077

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown PRINTER OEP-6