BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GLIDESCOPE GO

    MDR report key: 15715297 · Received November 1, 2022

    Report

    Report Number
    MW5113008
    Event Type
    Injury
    Date Received
    November 1, 2022
    Date of Event
    September 13, 2022
    Report Date
    October 30, 2022
    Manufacturer
    VERATHON INC.
    Product Code
    CCW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OK, US
    Reporter Occupation
    117
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    I HAVE USED A GLIDESCOPE GO MONITOR FOR CLOSE TO TWO YEARS. THE SEAM SURROUNDING THE MONITOR WASN'T SEALED PROPERLY. A STRESS FRACTURE OCCURRED FROM THE SEAM TO AN OPEN AREA LOCATED BY THE BUTTON. I ATTEMPTED TO EXPLAIN TO VERATHON REPRESENTATIVES THAT I NEVER DROPPED THE UNIT OR CAUSED ANY TRAUMA TO THE UNIT. I ALSO ONLY USED THE AF3 WIPES RECOMMENDED BY VERATHON TO CLEAN MY UNIT. MY BIGGEST CONCERNS ARE THAT FLUID COULD SLOWLY ENTER INTO THE GLIDESCOPE CAUSING MALFUNCTION AND RENDERING IT USELESS AND POSSIBLY EVEN CAUSING PATIENT HARM. THE OTHER MAJOR CONCERN IS RISK OF INFECTION AND TRANSMISSION OF BLOOD-BORNE DISEASES SECONDARY TO FLUID REMAINING WITHIN THE GLIDESCOPE AND BEING TRANSMITTED FROM PATIENT TO PATIENT. I REPEATEDLY COMMUNICATED MY CONCERNS TO VERATHON REPRESENTATIVES. MY CONCERNS WERE IGNORED BY VERATHON WITH A RESPONSE THAT I HAD CAUSED THE DAMAGE. I REITERATED THAT I NEVER DROPPED THE UNIT OR CAUSED ANY HARM TO IT AND THAT I ONLY WIPED THE UNIT WITH AF3 WIPES AS INSTRUCTED BY VERATHON. THEY REITERATED THAT I MUST HAVE CAUSED THE DAMAGE. I WENT AHEAD AND PAID A FEE TO HAVE MY GLIDESCOPE GO REPLACED BY VERATHON, BUT MY MAIN CONCERN REMAINED. THIS COULD BE OCCURRING WITHOUT CLINICIANS KNOWING AND VERATHON IGNORED MY CONCERN REGARDING THIS SYSTEMIC PROBLEM WITH GLIDESCOPE GO UNITS. THE REPRESENTATIVES MAINTAINED THAT THE DAMAGE WAS CAUSE BY ME WHICH IS INCORRECT AS COMMUNICATED TO THEM REPEATEDLY. THE ULTIMATE VICTIM THROUGH ALL THIS IS THE PATIENT AS GLIDESCOPE GO UNITS ACROSS THE WORLD COULD FAIL UNEXPECTEDLY AND BECOME VECTORS FOR DISEASE TRANSMISSION. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2949012 GLIDESCOPE GO LARYNGOSCOPE, RIGID CCW VERATHON INC. 0570-0366 (11) 201117

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Life Threatening AF3 WIPES