BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4K CAMERA HEAD

    MDR report key: 11500592 · Received March 17, 2021

    Report

    Report Number
    8010047-2021-03833
    Event Type
    Malfunction
    Date Received
    March 17, 2021
    Date of Event
    February 22, 2021
    Report Date
    April 26, 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

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION. 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 UPON THE REPORTED INFORMATION, IT IS PRESUMED THAT THIS CASE WAS CAUSED BY UNEXPECTED STRESS ON THE CAMERA HEAD DUE TO THE USER'S HANDLING, RESULTING IN THE FAILURE OF THE CCD UNIT, WHICH RESULTED IN THE ABSENCE OF IMAGES. THE INSTRUCTION MANUAL PROVIDES PREVENTIVE MEASURES AGAINST THE REPORTED FAILURE MODE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO OMSC BUT WAS RETURNED TO OLYMPUS CHINA SALES & MARKETING (OCSM) FOR EVALUATION. OCSM INSPECTED THE DEVICE AND CONFIRMED THE FOLLOWING; -THE REPORTED PHENOMENON WAS REPRODUCED. -THE REPORTED PHENOMENON MAY HAVE BEEN CAUSED BY A CCD UNIT FAILURE. -SINCE THE ENDOSCOPIC IMAGE WAS NOT DISPLAYED, THE WHITE BALANCE, MODEL NAME/SERIAL NUMBER DISPLAY, REMOTE SWITCH AND FOCUS FUNCTION, AND THE IMAGE QUALITY OF THE ENDOSCOPIC IMAGE COULD NOT BE CONFIRMED. -THIS DEVICE WAS USED AND INSPECTED WITH AN OLYMPUS VIDEO SYSTEM CENTER OTV-S400, LIGHT SOURCE CLV-S400, A SONY MONITOR LMD-X310S. 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 BY THE USER THAT DURING THE INSTALLATION, THE ENDOSCOPIC IMAGE OF THE DEVICE WAS NOT DISPLAYED.AFTER THE REPORTED MALFUNCTION OCCURRED, THE USER STOPPED USING THE DEVICE.THIS DEVICE IS AN OLYMPUS ASSET AND NO MALFUNCTION OCCURRED IN THE HOSPITAL.THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401339 4K CAMERA HEAD CAMERA HEAD FET OLYMPUS MEDICAL SYSTEMS CORP. CH-S400-XZ-EB

    Patients

    Seq Age Sex Outcome Treatment
    1