BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GLIDESCOPE GVL 4

    MDR report key: 3377739 · Received September 12, 2013

    Report

    Report Number
    9615393-2013-00169
    Event Type
    Malfunction
    Date Received
    September 12, 2013
    Date of Event
    June 22, 2010
    Report Date
    June 22, 2010
    Manufacturer
    VERATHON MEDICAL (CANADA) ULC.
    Product Code
    CCW
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    3022472-5-07-2013-0001-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONFIRMED BLADE TIP HAS BROKEN OFF. 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

    TIP OF BLADE HAS BROKEN OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    459210 GLIDESCOPE GVL 4 VIDEO LAYRYNGOSCOPE BLADE CCW VERATHON MEDICAL (CANADA) ULC. 0574-0001

    Patients

    Seq Age Sex Outcome Treatment
    1 NA