BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISERA ELITE II VIDEO SYSTEM CENTER

    MDR report key: 11996802 · Received June 14, 2021

    Report

    Report Number
    8010047-2021-07508
    Event Type
    Malfunction
    Date Received
    June 14, 2021
    Report Date
    July 7, 2021
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    OWN
    PMA / PMN Number
    K200542
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION. THE DEVICE WAS RETURNED TO OLYMPUS REPAIR CENTER, BUT NOT RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC). THEREFORE, OMSC COULD NOT CONFIRM THE DEVICE. DEVICE HISTORY RECORD REVIEW INDICATES THAT THE PRODUCT WAS MANUFACTURED AND TESTED IN ACCORDANCE WITH ALL APPLICABLE PROCEDURES AND MET ALL FINAL PRODUCT RELEASE CRITERIA. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED. OMSC SURMISED THAT THIS PHENOMENON ATTRIBUTED TO THE BROKEN FAN OF THE DEVICE BY THE USER HANDLING. IF SIGNIFICANT ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE SUPPLEMENTED.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC), BUT RETURNED TO OLYMPUS REPAIR CENTER FOR EVALUATION. ACCORDING TO THE EVALUATION, THE FOLLOWING WAS FOUND. POWER SUPPLY UNIT COOLING FANS WERE NOT ROTATING DUE TO THE FAN WAS CRACKED. REAR PANEL FAN MADE A NOISE DUE TO A FAILURE FAN UNIT. TOP COVER AND REAR PANEL WERE DENTED. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED AT THIS TIME. IF SIGNIFICANT ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE SUPPLEMENTED.

    Description of Event or Problem · 1

    THE COOLING FAN MOTOR OF THE DEVICE DID NOT WORK. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THIS EVENT. THE USER FACILITY DID NOT PROVIDE OTHER DETAILED INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    892775 VISERA ELITE II VIDEO SYSTEM CENTER VIDEO SYSTEM CENTER OWN OLYMPUS MEDICAL SYSTEMS CORP. OTV-S200

    Patients

    Seq Age Sex Outcome Treatment
    1