BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISERA 4K UHD CAMERA CONTROL UNIT

    MDR report key: 10909864 · Received November 26, 2020

    Report

    Report Number
    8010047-2020-09489
    Event Type
    Malfunction
    Date Received
    November 26, 2020
    Date of Event
    October 27, 2020
    Report Date
    January 5, 2021
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FET
    PMA / PMN Number
    K151011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION. THE SUBJECT DEVICE WAS NOT RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOR EVALUATION BUT WAS RETURNED TO OLYMPUS (BEIJING) SALES & SERVICE CO., LTD(OCSM). WHEN OCSM REINSTALLING THE CPU OF THE SUBJECT DEVICE, THE SUBJECT DEVICE WAS WORKED FINE. OMSC REVIEWED THE MANUFACTURE HISTORY (DHR) OF THE SUBJECT DEVICE AND CONFIRMED NO IRREGULARITY. THE EXACT CAUSE OF THE REPORTED PHENOMENON COULD NOT BE CONCLUSIVELY DETERMINED. HOWEVER, BASED UPON THE INFORMATION FROM OCSM, THERE WAS THE POSSIBILITY THAT THE REPORTED PHENOMENON WAS ATTRIBUTED TO THE FOLLOWING CAUSES. -FAILURE TO TURN ON THE POWER MIGHT BE CAUSED BY CONTACT FAILURE OF THE CPU. CONTACT FAILURE OF THE CPU MIGHT BE CAUSED BY ADHESION OF DUST OR HIGH HUMIDITY.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO OMSC FOR 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 INSPECTED THE DEVICE AT THE SERVICE DEPARTMENT OF OLYMPUS TRADING (B)(4) (OSH) FOUND THAT THE DEVICE DIDN'T TURN ON. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1377326 VISERA 4K UHD CAMERA CONTROL UNIT VIDEO SYSTEM CENTER FET OLYMPUS MEDICAL SYSTEMS CORP. OTV-S400

    Patients

    Seq Age Sex Outcome Treatment
    1