BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GLIDESCOPE GVL 5

    MDR report key: 4930979 · Received July 17, 2015

    Report

    Report Number
    9615393-2015-00060
    Event Type
    Injury
    Date Received
    July 17, 2015
    Date of Event
    June 1, 2015
    Report Date
    June 8, 2015
    Manufacturer
    VERATHON MEDICAL ULC.
    Product Code
    CCW
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION SUMMARY: THIS PRODUCT HAS NOT BEEN RECEIVED BACK FOR EVALUATION AT THE TIME OF THIS REPORT. THE PROBLEM CANNOT BE CONFIRMED. IF THE SUSPECT DEVICE IS BEING RETURNED AND A SUPPLEMENTAL REPORT WILL BE ISSUED WITH THE RESULTS OF THE EVALUATION. ON 05/10/2013 SAFETY ALERT NOTICE C/R 3022472-5-07-2013-0001-C WAS ISSUED TO ALL CUSTOMERS 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.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION SUMMARY: THE RETURNED DEVICE WAS EVALUATED AND OUR TECHNICIAN COULD NOT CONFIRM ANY SHARP EDGES ON THE DEVICE. THE BLADE WAS FOUND TO HAVE DELAMINATION, A MISSING SEALING CAP, AND THE PLASTIC PLATE ON TOP OF THE SERIAL NUMBER WAS DAMAGED. ON 5/10/2013 SAFETY ALERT NOTICE C/R 3022472-5-07-2013-0001-C WAS ISSUED TO ALL CUSTOMERS 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

    DURING INTUBATION USING THE GLIDESCOPE GVL 5, A PATIENT WAS INJURED DUE TO A SHARP EDGE ON THE TIP OF THE BLADE. THE PATIENT WAS FINE AFTER THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    466377 GLIDESCOPE GVL 5 VIDEO LARYNGOSCOPE CCW VERATHON MEDICAL ULC. GLIDESCOPE GVL 5

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention