BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GLIDESCOEP GVL 5

    MDR report key: 3573335 · Received November 1, 2013

    Report

    Report Number
    9615393-2013-00271
    Event Type
    Malfunction
    Date Received
    November 1, 2013
    Date of Event
    May 21, 2013
    Report Date
    May 21, 2013
    Manufacturer
    VERATHON MEDICAL ULC
    Product Code
    CAL
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SAFETY ALERT NOTICE C/R 3022472-5-07-2013-001-C 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. (B)(4).

    Description of Event or Problem · 1

    ABOUT 1/3 OF THE GLIDESCOPE BLADE TIP IS CRACKED AND BARELY ATTACHED. NO PT INVOLVEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    564766 GLIDESCOEP GVL 5 VIDEO LARYNGOSCOPE CAL VERATHON MEDICAL ULC 0003-0378

    Patients

    Seq Age Sex Outcome Treatment
    1 NA