BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPUS

    MDR report key: 6084918 · Received November 8, 2016

    Report

    Report Number
    8010047-2016-01429
    Event Type
    Malfunction
    Date Received
    November 8, 2016
    Date of Event
    October 14, 2016
    Report Date
    November 8, 2016
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    EOB
    PMA / PMN Number
    K061313
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURING RECORD OF THE DEVICE WAS REVIEWED WITHOUT IRREGULARITY. THE SUBJECT DEVICE WAS RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP FOR EVALUATION. WHEN THE SUBJECT DEVICE WAS CONNECTED TO A VIDEO SYSTEM CENTER AT (B)(4) OLYMPUS, THE REPORTED PHENOMENON REPRODUCED. THE LIGHT GUIDE CONNECTOR AND VIDEO CONNECTOR WERE DISASSEMBLED, BUT THERE WAS NO ABNORMALITY AND TRACE OF LIQUID INVASION FOUND INSIDE. THE EXACT CAUSE OF THE REPORTED PHENOMENON HAS NOT BEEN DETERMINED AT THIS TIME. OMCS IS CONDUCTING FURTHER INVESTIGATION NOW, AND IF SIGNIFICANT ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE SUPPLEMENTED.

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT THE ENDOSCOPIC IMAGE DISAPPEARED DURING AN UNIDENTIFIED PROCEDURE WITH THE SUBJECT DEVICE. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    738614 OLYMPUS RHINO-LARYNGO VIDEOSCOPE EOB OLYMPUS MEDICAL SYSTEMS CORPORATION ENF-VT2

    Patients

    Seq Age Sex Outcome Treatment
    1