BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TITANIUM LOPRO T4

    MDR report key: 6619302 · Received June 7, 2017

    Report

    Report Number
    9615393-2017-00098
    Event Type
    Malfunction
    Date Received
    June 7, 2017
    Date of Event
    May 5, 2017
    Report Date
    May 10, 2017
    Manufacturer
    VERATHON MEDICAL ULC
    Product Code
    CCW
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER WAS PROVIDED A REPLACEMENT GLIDESCOPE TITANIUM LOPRO T4 BLADE. THE GLIDESCOPE TITANIUM LOPRO T4 BLADE WAS RETURNED TO VERATHON FOR EVALUATION. THE TECHNICAL SERVICE REPRESENTATIVE ATTACHED THE BLADE TO A TEST VIDEO MONITOR, THE LED APPEARED TO FUNCTION AS EXPECTED. THE BLADE WAS TESTED FOR SEVEN MINUTES OCCASIONALLY MANIPULATING THE BLADE. DURING THE TESTING THE REPORTED BRIGHT LED AND THE "ATTACH VIDEO CABLE" MESSAGE COULD NOT BE DUPLICATED. SINCE THE CUSTOMER RECEIVED A REPLACEMENT GLIDESCOPE TITANIUM LOPRO T4 BLADE THE RETURNED BLADE WAS SCRAPPED.

    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 TITANIUM LOPRO T4 BLADE, THE LED GAVE A BRIGHT LIGHT AND THE VIDEO MONITOR DISPLAYED THE "ATTACH VIDEO CABLE" MESSAGE WITH NO VIDEO. NO DELAY IN THE PROCEDURE WAS REPORTED AS A BACKUP TITANIUM LOPRO T4 WAS IMMEDIATELY AVAILABLE. NO HARM TO PATIENT OR USER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    400201 TITANIUM LOPRO T4 LARYNGOSCOPE, RIGID, CCW VERATHON MEDICAL ULC 0574-0127 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1