BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4K CAMERA HEAD

    MDR report key: 12646396 · Received October 18, 2021

    Report

    Report Number
    8010047-2021-13275
    Event Type
    Malfunction
    Date Received
    October 18, 2021
    Date of Event
    September 14, 2021
    Report Date
    October 18, 2021
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FET
    PMA / PMN Number
    K172817
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE SUBJECT DEVICE WAS NOT RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOR EVALUATION. THE MANUFACTURING RECORD WAS REVIEWED AND FOUND NO IRREGULARITIES. OMSC PRESUMED THAT COMMUNICATION WITH THE PROCESSOR BECAME IMPOSSIBLE DUE TO BREAK OF CABLE, THEN NO IMAGE WAS DISPLAYED. THE BREAK OF CABLE MIGHT BE DUE TO USER'S HANDLING.

    Description of Event or Problem · 0

    OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED THAT DURING THE INCOMING INSPECTION FOR REPAIR AT LOCAL SERVICE DEPARTMENT OF OLYMPUS, IT WAS FOUND THAT THERE WAS NO IMAGE DUE TO DEFECTIVE CABLE. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1544584 4K CAMERA HEAD CAMERA HEAD FET OLYMPUS MEDICAL SYSTEMS CORP. CH-S400-XZ-EB

    Patients

    Seq Age Sex Outcome Treatment
    1