BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GLIDESCOPE GVL 3

    MDR report key: 3802313 · Received February 19, 2014

    Report

    Report Number
    9615393-2014-00005
    Event Type
    Malfunction
    Date Received
    February 19, 2014
    Date of Event
    January 27, 2014
    Report Date
    January 27, 2014
    Manufacturer
    VERATHON MEDICAL ULC.
    Product Code
    CCW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE GLIDESCOPE EVAL IS IN PROGRESS. SAFETY ALERT NOTICE C/R 3022472-5-07-2013-0001-C WAS ISSUED TO ALL CUSTOMERS ON 05/10/2013 TO PROVIDE ADD'L 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. THIS DEVICE IS ~6 YEARS OLD.

    Description of Event or Problem · 1

    DURING AN INSPECTION OF THE GLIDESCOPE VIDEO LARYNGOSCOPE, THE CUSTOMER FOUND THAT THE END HAD BROKEN OFF. THERE WAS NO PT HARM, OR ANY REPORT OF PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104072 GLIDESCOPE GVL 3 VIDEO LARYNGOSCOPE CCW VERATHON MEDICAL ULC. 0574-0007

    Patients

    Seq Age Sex Outcome Treatment
    1