BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4K CAMERA HEAD

    MDR report key: 10054834 · Received May 14, 2020

    Report

    Report Number
    8010047-2020-02693
    Event Type
    Malfunction
    Date Received
    May 14, 2020
    Date of Event
    April 21, 2020
    Report Date
    June 6, 2020
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FET
    PMA / PMN Number
    K172817
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION. THE SUBJECT DEVICE WAS NOT RETURNED TO THE OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOR EVALUATION. OMSC REVIEWED THE MANUFACTURE HISTORY (DHR) OF THE DEVICE AND CONFIRMED NO IRREGULARITY. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED, HOWEVER, BASED UPON THE INFORMATION FROM OLYMPUS KEY MED LTD, (OKM) , THERE WAS THE POSSIBILITY THAT THIS PHENOMENON WAS ATTRIBUTED TO THE MALFUNCTION OF THE CAMERA CABLE.

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE IN THIS REPORT 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 MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED THAT THE ENDOSCOPIC IMAGE OF THE SUBJECT DEVICE COULD NOT BE DISPLAYED. ALSO THE FACILITY STATED THAT THERE WAS SOME FAILURE ON THE CAMERA CABLE OF THE SUBJECT DEVICE. IN THE EVALUATION OF OLYMPUS KEY MED LTD, (OKM) THE FOLLOWING WAS CONFIRMED, NO ABNORMALITIES WERE FOUND BY VISUAL INSPECTION OF THE OUTSIDE AND INTERNAL ASSEMBLY OF THE SUBJECT DEVICE. THERE WAS NO ABNORMALITY IN THE WATER LEAK INSPECTION. WHEN THE SUBJECT DEVICE WAS CONNECTED TO A CAMERA CONTROL UNIT OTV-S400, THE CAMERA HEAD COMMUNICATION ERROR E224 WAS DISPLAYED AND THE IMAGE TURNED BLUE TINT. OTHER DETAILED INFORMATION WAS NOT PROVIDED. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    521501 4K CAMERA HEAD CAMERA HEAD FET OLYMPUS MEDICAL SYSTEMS CORP. CH-S400-XZ-EB

    Patients

    Seq Age Sex Outcome Treatment
    1