BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4K CAMERA HEAD

    MDR report key: 10373224 · Received August 6, 2020

    Report

    Report Number
    8010047-2020-05333
    Event Type
    Malfunction
    Date Received
    August 6, 2020
    Date of Event
    July 15, 2020
    Report Date
    August 6, 2020
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FET
    PMA / PMN Number
    K172817
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    SINCE THE SUBJECT DEVICE WAS NOT RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC), IT COULD NOT BE INVESTIGATED. OMSC REVIEWED THE MANUFACTURING HISTORY (DHR) OF THE SUBJECT DEVICE AND CONFIRMED NO IRREGULARITY. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED. HOWEVER BASED ON THE REPORT OF OLYMPUS (B)(4), OMSC SURMISED THERE WAS THE POSSIBILITY THIS PHENOMENON WAS ATTRIBUTED TO THE CAMERA CABLE DAMAGE OF THE SUBJECT DEVICE WHICH WAS MADE BY THE USER HANDLING. IT MIGHT BE OCCURRED THAT THE IMAGE OF THE SUBJECT DEVICE WAS NOT APPEARED WITH NO IMAGE TRANSMISSION TO THE PROCESSOR DUE TO THE CAMERA CABLE DAMAGE OF THE SUBJECT DEVICE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED.

    Description of Event or Problem · 1

    OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED THAT THE IMAGE OF THE SUBJECT DEVICE WAS NOT APPEARED DURING THE INCOMING INSPECTION AT THE OLYMPUS (B)(4). MOREOVER WHEN OLYMPUS (B)(4) USE THE TEST CABLE OWNED BY OLYMPUS (B)(4) WITH THE SUBJECT DEVICE , THE IMAGE OF THE SUBJECT DEVICE WAS APPEARED BUT THERE WERE THE WHITE DOTS. THERE WAS NO PATIENT INJURY ASSOCIATED WITH THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    839087 4K CAMERA HEAD CAMERA HEAD FET OLYMPUS MEDICAL SYSTEMS CORP. CH-S400-XZ-EB

    Patients

    Seq Age Sex Outcome Treatment
    1