BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GLIDESCOPE AVL VIDEO BATON 3-4

    MDR report key: 6560573 · Received May 11, 2017

    Report

    Report Number
    9615393-2017-00085
    Event Type
    Malfunction
    Date Received
    May 11, 2017
    Date of Event
    April 26, 2017
    Report Date
    April 26, 2017
    Manufacturer
    VERATHON MEDICAL ULC
    Product Code
    CCW
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS CONFIRMED THAT THE CUSTOMER HAS PURCHASED A REPLACEMENT GLIDESCOPE AVL 3-4 VIDEO BATON. HOWEVER, THE VIDEO BATON FROM THE REPORTED INCIDENT WAS NOT RETURNED FOR FURTHER 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 AN GLIDESCOPE AVL 3-4 VIDEO BATON, THE IMAGE WOULD TURN TO STATIC OR CUT OUT WHEN THE FLEXIBLE TUBING WAS BENT. NO DELAY IN THE PROCEDURE WAS REPORTED, HOWEVER THE USE OF A BACK-UP GLIDESCOPE AVL 3-4 VIDEO BATON WAS REPORTED. NO HARM TO PATIENT OR USER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342595 GLIDESCOPE AVL VIDEO BATON 3-4 LARYNGOSCOPE, RIGID CCW VERATHON MEDICAL ULC 0570-0307 NA

    Patients

    Seq Age Sex Outcome Treatment
    1