BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GLIDESCOPE SMART CABLE

    MDR report key: 6487067 · Received April 12, 2017

    Report

    Report Number
    9615393-2017-00074
    Event Type
    Malfunction
    Date Received
    April 12, 2017
    Date of Event
    March 20, 2017
    Report Date
    March 30, 2017
    Manufacturer
    VERATHON MEDICAL ULC
    Product Code
    CCW
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    A REPLACEMENT SMART CABLE WAS PROVIDED TO THE CUSTOMER. THE RETURNED SMART CABLE WAS EVALUATED BY VERATHON TECHNICAL SERVICES AND THE INTERMITTENT IMAGE WAS CONFIRMED. DURING TESTING IT WAS OBSERVED WHEN THE SMART CABLE WAS MANIPULATED NEAR THE CONNECTOR THE IMAGE WOULD CUT OUT. THE SMART CABLE WAS FORWARDED TO VERATHON (B)(4) FOR FURTHER INVESTIGATION. VERATHON CONTINUES TO INVESTIGATE THE REPORTED EVENT AND A SUPPLEMENTAL REPORT WILL BE SUBMITTED IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    THIS IS AN INITIAL REPORT AND THE PRODUCT HAS NOT YET BEEN RECEIVED FOR EVALUATION. SHOULD THE DEVICE BE RETURNED, THE DEVICE EVALUATION DATA WILL BE INCLUDED IN A FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING A PATIENT PROCEDURE, USING A GLIDESCOPE SMART CABLE, THE IMAGE WOULD GO OUT WHEN THE SMART CABLE WAS MANIPULATED. REPORTEDLY WHEN THE SMART CABLE WAS PRESSED IN A SPECIFIC LOCATION THE IMAGE COULD BE SEEN, BUT WHEN RELEASED THE IMAGE DISAPPEARED. NO DELAY IN THE PROCEDURE OR USE OF A BACK-UP DEVICE WAS REPORTED. NO HARM TO THE PATIENT OR THE USER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    267942 GLIDESCOPE SMART CABLE LARYNGOSCOPE, RIGID CCW VERATHON MEDICAL ULC 0800-0522

    Patients

    Seq Age Sex Outcome Treatment
    1