BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HD AUTOCLAVABLE CAMERA HEAD

    MDR report key: 10539128 · Received September 16, 2020

    Report

    Report Number
    8010047-2020-06565
    Event Type
    Malfunction
    Date Received
    September 16, 2020
    Report Date
    October 14, 2020
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION. OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) COULD NOT INVESTIGATE THE DEVICE, BECAUSE THE DEVICE WAS NOT RETURNED TO OMSC. OMSC REVIEWED THE MANUFACTURING HISTORY OF THE DEVICE AND CONFIRMED NO IRREGULARITY. SINCE THE DEVICE WAS NOT RETURNED, THE EXACT CAUSE COULD NOT BE CONCLUSIVELY DETERMINED, BUT THERE WAS A POSSIBILITY OF FAILURE OF CCD UNIT. THE INSTRUCTION MANUAL OF THE DEVICE STATES THE CORRESPONDING METHOD IN CASE OF AN ABNORMALITY.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOR EVALUATION. THERE WERE NO FURTHER DETAILS PROVIDED. IF SIGNIFICANT ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE SUPPLEMENTED.

    Description of Event or Problem · 1

    OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED THE FACILITY THAT IN UNSPECIFIED TIMING A SCOPE ERR E315 APPEARED ON THE MONITOR AND A COLOR BAR APPEARED ON THE MONITOR. THE USER REPLACED THE DEVICE TO ANOTHER DEVICE AND NORMAL ENDOSCOPIC IMAGE APPEARED ON THE MONITOR. 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
    1003784 HD AUTOCLAVABLE CAMERA HEAD CAMERA HEAD GCJ OLYMPUS MEDICAL SYSTEMS CORP. OTV-S7PROH-FD

    Patients

    Seq Age Sex Outcome Treatment
    1