BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GLIDESCOPE GVL 3

    MDR report key: 2972585 · Received February 15, 2013

    Report

    Report Number
    9615393-2013-00085
    Event Type
    Malfunction
    Date Received
    February 15, 2013
    Date of Event
    January 18, 2013
    Report Date
    January 18, 2013
    Manufacturer
    VERATHON MEDICAL (CANADA) ULC.
    Product Code
    CCW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED ISSUE WAS CONFIRMED. VISUAL INSPECTION ALSO IDENTIFIED THAT THE CASING ON THE HANDLE WAS CRACKED. THE DEVICE WAS REPLACED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE MONITOR WITH THE BLADE DISPLAYED GREEN, YELLOW AND SWIRLING YELLOW COLORS. IT ONLY OCCURRED WITH ONE BLADE. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69405 GLIDESCOPE GVL 3 NONE CCW VERATHON MEDICAL (CANADA) ULC. 0574-0007

    Patients

    Seq Age Sex Outcome Treatment
    1