BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GLIDESCOPE SMART CABLE

    MDR report key: 6677625 · Received June 29, 2017

    Report

    Report Number
    9615393-2017-00106
    Event Type
    Malfunction
    Date Received
    June 29, 2017
    Date of Event
    May 2, 2017
    Report Date
    June 2, 2017
    Manufacturer
    VERATHON MEDICAL ULC
    Product Code
    CCW
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER WAS PROVIDED WITH A REPLACEMENT SMART CABLE. THE SMART CABLE WAS RETURNED TO VERATHON FOR EVALUATION. THE TECHNICAL SERVICE REPRESENTATIVE CONNECTED THE SMART CABLE TO A TEST MONITOR AND BLADE, THE DISPLAYED IMAGE SHIFTED BETWEEN NORMAL, NO IMAGE AT ALL, AND GREEN STATIC. SINCE THE CUSTOMER RECEIVED A REPLACEMENT SMART CABLE THE RETURNED CABLE WAS SCRAPPED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING A PATIENT PROCEDURE, USING A GLIDESCOPE SMART CABLE, THE IMAGE WAS FLICKERING. REPORTEDLY A BACKUP GLIDESCOPE AVL SYSTEM WAS USED TO COMPLETE THE PROCEDURE, HOWEVER, THE LENGTH OF THE DELAY IN THE PROCEDURE WAS NOT REPORTED. NO HARM TO PATIENT OR USER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    457084 GLIDESCOPE SMART CABLE LARYNGOSCOPE, RIGID CCW VERATHON MEDICAL ULC 0800-0522 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1