BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDEO SYSTEM

    MDR report key: 10916892 · Received November 30, 2020

    Report

    Report Number
    8010047-2020-09583
    Event Type
    Malfunction
    Date Received
    November 30, 2020
    Report Date
    December 24, 2020
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FET
    PMA / PMN Number
    K954451
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS IS A SUPPLEMENTAL REPORT TO PROVIDE ADDITIONAL INFORMATION. THE SUBJECT DEVICE WAS NOT RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOR EVALUATION. THE MANUFACTURING RECORD WAS REVIEWED AND FOUND NO IRREGULARITIES. BASED ON THE PAST SIMILAR CASES, BECAUSE IT HAS BEEN MORE THAN 9 YEARS SINCE THE EQUIPMENT WAS INSTALLED, IT IS ASSUMED THAT THE PARTS ON THE BOARD HAVE DETERIORATED OVER TIME DUE TO REPEATED USE OVER A LONG PERIOD OF TIME, AND THE MAIN BOARD HAS FAILED. SINCE THE MAIN BOARD GENERATES AND OUTPUTS VIDEO SIGNALS, IT IS ASSUMED THAT THIS FAILURE CAUSED THE VIDEO OUTPUT NOT TO BE DISPLAYED.

    Additional Manufacturer Narrative · 1

    SINCE THE SUBJECT DEVICE HAS NOT BEEN RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOR THE EVALUATION, 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 FROM THE USER DURING THE UNSPECIFIED TIMING THAT BUILT-IN BATTERY IS DEAD. OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED THAT DURING THE INCOMING INSPECTION FOR REPAIR AT OLYMPUS SERVICE OPERATION REPAIR CENTER, IT WAS FOUND THAT VIDEO WAS NOT DISPLAYED DUE TO THE PRINTED CIRCUIT BOARD FAILURE. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1382633 VIDEO SYSTEM VIDEO SYSTEM CENTER FET OLYMPUS MEDICAL SYSTEMS CORP. OTV-SI

    Patients

    Seq Age Sex Outcome Treatment
    1