BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GVL 4 STAT GLIDESCOPE COVER

    MDR report key: 8394166 · Received March 5, 2019

    Report

    Report Number
    MW5084670
    Event Type
    Injury
    Date Received
    March 5, 2019
    Date of Event
    February 21, 2019
    Report Date
    March 4, 2019
    Manufacturer
    VERATHON INC.
    Product Code
    CCW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KY, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING A DIFFICULT INTUBATION IN THE EMERGENCY DEPARTMENT ON THIS ELDERLY GENTLEMAN, THE ED PHYSICIAN WAS USING A GLIDESCOPE WITH A DISPOSABLE PLASTIC COVER THAT BROKE DURING USE. VISUALIZATION WAS NOT ADEQUATE, SO THE PHYSICIAN RETRACTED THE GLIDESCOPE TO FIND THAT THE TIP OF THE DISPOSABLE PLASTIC COVER, APPROXIMATELY 2 INCHES IN LENGTH, HAD BROKEN OFF IN THE PATIENT¿S THROAT AND HAD BECOME LODGED. UPON OPENING A SECOND GLIDESCOPE COVER THE TIP WAS FOUND TO BE NEARLY SEVERED IN THE PACKAGE. THE PATIENT WAS SUCCESSFULLY INTUBATED WITH THE PLASTIC TIP REMAINING IN THE PATIENT¿S THROAT FOR LESS THAN 30 MINUTES WHEN A CRNA WAS NOTIFIED AND WAS ABLE TO REMOVE THE RETAINED PLASTIC COVER TIP USING A GLIDESCOPE AND SPECIAL TOOL WITHOUT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    186467 GVL 4 STAT GLIDESCOPE COVER LARYNGOSCOPE, RIGID CCW VERATHON INC. GF49538

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention