BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GLIDESCOPE GVL 4

    MDR report key: 3377636 · Received September 12, 2013

    Report

    Report Number
    9615393-2013-00232
    Event Type
    Malfunction
    Date Received
    September 12, 2013
    Date of Event
    May 24, 2012
    Report Date
    May 24, 2012
    Manufacturer
    VERATHON MEDICAL (CANADA) ULC.
    Product Code
    CCW
    Removal / Correction Number
    3022472-5-07-2013-0001-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: IMMEDIATE VISIBLE DAMAGE, TIP CRACKED. 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 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

    THE BLADE TIP IS BROKEN OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    458373 GLIDESCOPE GVL 4 VIDEO LARYNGOSCOPE CCW VERATHON MEDICAL (CANADA) ULC. 0574-0007

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention