BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA II VIDEO SYSTEM CENTER

    MDR report key: 10118434 · Received June 4, 2020

    Report

    Report Number
    8010047-2020-03104
    Event Type
    Malfunction
    Date Received
    June 4, 2020
    Date of Event
    April 26, 2020
    Report Date
    June 4, 2020
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FAJ
    UDI-DI
    04953170215513
    PMA / PMN Number
    K133538
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE WAS NOT BEEN RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOR EVALUATION. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED.

    Description of Event or Problem · 1

    OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED FROM THE FACILITY THAT DURING PREPARATION FOR USE THE NOISE APPEARED ON THE ENDOSCOPIC IMAGE. THE SERVICE DEPARTMENT OF OLYMPUS (B)(4) CHECKED THE SUBJECT DEVICE AND FOUND THAT THE SUBJECT DEVICE COULD NOT START UP INTERMITTENTLY AND THERE WAS NO SIGNAL OUTPUT DUE TO THE ELECTRICAL CIRCUIT BOARD DAMAGED. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    581531 EVIS EXERA II VIDEO SYSTEM CENTER VIDEO SYSTEM CENTER FAJ OLYMPUS MEDICAL SYSTEMS CORP. CV-180 04953170215513

    Patients

    Seq Age Sex Outcome Treatment
    1