BEUDAMED
    FDA Adverse Event Other Summary report: N

    SCOPE, 5MM CUSTOM EXTENDED LENGTH

    MDR report key: 241759 · Received September 16, 1999

    Report

    Report Number
    2939738-1999-00031
    Event Type
    Other
    Date Received
    September 16, 1999
    Date of Event
    August 24, 1999
    Report Date
    September 1, 1999
    Manufacturer
    GUIDANT CORP., CARDIAC & VASCULAR SURGERY GROUP, ORIGIN MEDSYSTEMS, INC.
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    SCOPE HAS A HALF MOON SHAPE AT THE BOTTOM. IT HAPPENED ON 08/24/1999. PT CONVERTED TO STANDARD OPEN PROCEDURE BECAUSE SCOPE IMAGE WAS INADEQUATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCOPE, 5MM CUSTOM EXTENDED LENGTH SCOPE GCJ GUIDANT CORP., CARDIAC & VASCULAR SURGERY GROUP, ORIGIN MEDSYSTEMS, INC. OMS-5LSSO 012298

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Other