BEUDAMED
    FDA Adverse Event Summary report: N

    GLIDESCOPE GVL 4

    MDR report key: 3302828 · Received August 16, 2013

    Report

    Report Number
    9615393-2013-00160
    Date Received
    August 16, 2013
    Date of Event
    July 17, 2013
    Report Date
    August 16, 2013
    Manufacturer
    VERATHON MEDICAL (CANADA) ULC.
    Product Code
    CCW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    SAFETY ALERT NOTICE C/R (B)(4) ISSUED TO ALL CUSTOMERS ON 05/10/2013 TO PROVIDE ADDITIONAL SAFETY INFO 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

    ON (B)(6) 2013 THE CUSTOMER CONTACTED VERATHON INC IN REGARDS TO A GLIDESCOPE GVL 4 BLADE (VIDEO LARYNGOSCOPE BLADE) THAT WAS BROKEN AT THE END OF THE BLADE. THE CUSTOMER IDENTIFIED THE DAMAGE DURING INSPECTION. THERE WAS NO PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    398469 GLIDESCOPE GVL 4 VIDEO LARYNGOSCOPE BLADE CCW VERATHON MEDICAL (CANADA) ULC. 0574-0001

    Patients

    Seq Age Sex Outcome Treatment
    1