BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISERA ELITE II VIDEO SYSTEM CENTER

    MDR report key: 10424215 · Received August 19, 2020

    Report

    Report Number
    8010047-2020-05598
    Event Type
    Malfunction
    Date Received
    August 19, 2020
    Date of Event
    July 21, 2020
    Report Date
    October 22, 2020
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    OWN
    PMA / PMN Number
    K200542
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION. OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) COULD NOT INVESTIGATE THE DEVICE, BECAUSE THE DEVICE WAS NOT RETURNED TO OMSC. OMSC REVIEWED THE MANUFACTURING HISTORY (DHR) OF THE DEVICE AND CONFIRMED NO IRREGULARITY. OLYMPUS LOCAL SERVICE ENGINEER REPORT THAT THE POWER SUPPLY CIRCUIT BOARD OF THE DEVICE WAS BROKEN. OMSC SURMISED THAT THE REPORTED PHENOMENON WAS OCCURRED DUE TO THE PART OF THE POWER SUPPLY CIRCUIT BOARD OF THE DEVICE WAS A SHORT CIRCUIT BY SOME CAUSE. THE INSTRUCTION MANUAL OF THE DEVICE STATES THE CORRESPONDING METHOD IN CASE OF AN ABNORMALITY.

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE HAS NOT RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOR EVALUATION. THERE WERE NO FURTHER DETAILS PROVIDED. IF SIGNIFICANT ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE SUPPLEMENTED.

    Description of Event or Problem · 1

    THE DEVICE SPARKED WHEN THE USER TURNED ON IT DURING PREPARATION FOR USE. OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED THAT DURING THE INCOMING INSPECTION FOR REPAIR AT OLYMPUS SERVICE OPERATION REPAIR CENTER, IT WAS FOUND THAT THE POWER UNIT OF THE SUBJECT DEVICE FAILED. 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
    892403 VISERA ELITE II VIDEO SYSTEM CENTER VIDEO SYSTEM CENTER OWN OLYMPUS MEDICAL SYSTEMS CORP. OTV-S200

    Patients

    Seq Age Sex Outcome Treatment
    1