BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDEO SYSTEM CENTER

    MDR report key: 10151282 · Received June 13, 2020

    Report

    Report Number
    8010047-2020-03333
    Event Type
    Malfunction
    Date Received
    June 13, 2020
    Date of Event
    May 20, 2020
    Report Date
    June 13, 2020
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FET
    PMA / PMN Number
    K122831
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE WAS NOT RETURNED TO OMSC BUT WAS RETURNED TO OLYMPUS (B)(4) (OVN) FOR EVALUATION. OVN CHECKED THE DEVICE AND FOUND THAT THE VIDEO CONNECTOR SOCKET WAS DAMAGED. OVN PRESUMED THAT IT CAUSED THE ERROR B30. 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 THAT DURING A PREPARATION FOR USE OF THE SUBJECT DEVICE, THE ENDOSCOPIC IMAGE DISAPPEARED AND THE ERROR B30 WHICH INDICATED THAT THERE WAS THE COMMUNICATION PROBLEM BETWEEN THE ENDOSCOPE AND VIDEO PROCESSOR WAS DISPLAYED. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    615160 VIDEO SYSTEM CENTER VIDEO SYSTEM CENTER FET OLYMPUS MEDICAL SYSTEMS CORP. CV-170

    Patients

    Seq Age Sex Outcome Treatment
    1