BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GLIDESCOPE GVL 4

    MDR report key: 3377721 · Received September 12, 2013

    Report

    Report Number
    9615393-2013-00186
    Event Type
    Malfunction
    Date Received
    September 12, 2013
    Date of Event
    January 4, 2011
    Report Date
    January 4, 2011
    Manufacturer
    VERATHON MEDICAL (CANADA) ULC
    Product Code
    CCW
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONFIRMED REPORTED CUSTOMER COMPLAINT. 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

    BLADE IS BROKEN. NO OTHER INFORMATION AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    459577 GLIDESCOPE GVL 4 VIDEO LARYNGOSCOPE BLADE CCW VERATHON MEDICAL (CANADA) ULC 0574-0001

    Patients

    Seq Age Sex Outcome Treatment
    1