BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REF. FV 600

    MDR report key: 1531518 · Received November 17, 2009

    Report

    Report Number
    1531518
    Event Type
    Malfunction
    Date Received
    November 17, 2009
    Date of Event
    November 4, 2009
    Report Date
    November 17, 2009
    Manufacturer
    BRYAN CORP.
    Product Code
    GEX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE DEVICE DID NOT DO WHAT IT WAS SUPPOSED TO DO. IT IS DESIGNED TO LIGHT UP THE FIBEROPTICS WHEN PLUGGED INTO THE CONSOLE WHICH IS THE ELECTRIC SOURCE. THE DEVICE WAS "DEAD", DID NOT LIGHT UP. THE CONSOLE WORKED WHEN A NEW FIBER 600 WAS OPENED AND PLUGGED IN, SO THE CONSOLE WAS RULED OUT AND THE PROCEDURE WAS COMPLETED. THERE WAS NO SIGNIFICANT DELAY TO THE PROCEDURE, OR HARM TO THE PATIENT.

    Description of Event or Problem · 1

    THE DEVICE DID NOT DO WHAT IT WAS SUPPOSED TO DO. IT IS DESIGNED TO LIGHT UP THE FIBEROPTICS WHEN PLUGGED INTO THE CONSOLE WHICH IS THE ELECTRIC SOURCE. THE DEVICE WAS "DEAD", DID NOT LIGHT UP. THE CONSOLE WORKED WHEN A NEW FIBER 600 WAS OPENED AND PLUGGED IN, SO THE CONSOLE WAS RULED OUT AND THE PROCEDURE WAS COMPLETED. THERE WAS NO SIGNIFICANT DELAY TO THE PROCEDURE, OR HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REF. FV 600 FIBER OPTIC CABLE GEX BRYAN CORP. FV-600 A-9-314

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR