BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GLIDESCOPE GVL 2

    MDR report key: 3377719 · Received September 12, 2013

    Report

    Report Number
    9615393-2013-00187
    Event Type
    Malfunction
    Date Received
    September 12, 2013
    Date of Event
    January 12, 2011
    Report Date
    January 12, 2011
    Manufacturer
    VERATHON MEDICAL (CANADA) ULC.
    Product Code
    CCW
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). REPORTED FAILURE CONFIRMED. SAFETY ALERT NOTICE C/R 3022472-5-07-2013-0001-C ISSUED TO ALL CUSTOMERS ON 05/10/2013 TO PROVIDE ADDITIONAL SAFETY INFORMATION TO REMIND USERS TO CAREFULLY EXAMINE BLADES BEFORE AND AFTER EACH USE, AND PROMPTLY REPLACE ANY THAT SHOW SIGNS OF WEAR OR DAMAGE.

    Description of Event or Problem · 1

    BROKEN BLADE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    459821 GLIDESCOPE GVL 2 VIDEO LARYNGOSCOPE BLADE CCW VERATHON MEDICAL (CANADA) ULC. 0574-0010

    Patients

    Seq Age Sex Outcome Treatment
    1