BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GLIDESCOPE GVL 4

    MDR report key: 2974047 · Received February 19, 2013

    Report

    Report Number
    9615393-2013-00096
    Event Type
    Malfunction
    Date Received
    February 19, 2013
    Date of Event
    January 21, 2013
    Report Date
    January 21, 2013
    Manufacturer
    VERATHON MEDICAL (CANADA) ULC.
    Product Code
    CCW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR FURTHER EVALUATION. THEREFORE, THE REPORTED INCIDENT COULD NOT BE CONFIRMED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A LEAKAGE ON THE CONNECTOR AND A POOR QUALITY IMAGE DUE TO THE PENETRATION OF LIQUIDS INSIDE A GLIDESCOPE GVL 4 BLADE. NO PATIENT INVOLVEMENT OCCURRED DURING THE WITNESSING OF THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    72560 GLIDESCOPE GVL 4 NONE CCW VERATHON MEDICAL (CANADA) ULC. 0574-00001

    Patients

    Seq Age Sex Outcome Treatment
    1