BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HD AUTOCLAVABLE CAMERA HEAD

    MDR report key: 10783808 · Received November 4, 2020

    Report

    Report Number
    8010047-2020-08515
    Event Type
    Malfunction
    Date Received
    November 4, 2020
    Date of Event
    October 6, 2020
    Report Date
    November 4, 2020
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FET
    PMA / PMN Number
    K955404
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO OMSC FOR EVALUATION. IN THE EVALUATION OF THE SERVICE DEPARTMENT OF OLYMPUS (B)(4) (ONZ) THE FOLLOWING WAS CONFIRMED; THE REPORTED PHENOMENON WAS REPRODUCED. THE CAMERA HEAD WAS DEFECTIVE. OMSC REVIEWED THE MANUFACTURING HISTORY(DHR) OF THE DEVICE AND CONFIRMED NO IRREGULARITY. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED, HOWEVER THERE IS POSSIBILITY THAT THE REPORTED EVENT WAS CAUSED BY DEFECT OF THE CCD UNIT DUE TO EXCESSIVE STRESS BY CUSTOMER'S HANDLING ON THE CAMERA HEAD. 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 DISAPPEARED AND THE VISUAL FIELD WAS SUDDENLY LOST. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1248693 HD AUTOCLAVABLE CAMERA HEAD CAMERA HEAD FET OLYMPUS MEDICAL SYSTEMS CORP. OTV-S7PROH-HD-10E

    Patients

    Seq Age Sex Outcome Treatment
    1