BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GLIDESCOPE GVL 4

    MDR report key: 2974081 · Received February 19, 2013

    Report

    Report Number
    9615393-2013-00103
    Event Type
    Malfunction
    Date Received
    February 19, 2013
    Date of Event
    January 21, 2013
    Report Date
    January 21, 2013
    Manufacturer
    VERATHON MEDICAL (CANADA) ULC
    Product Code
    CCW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE COULD NOT BE PERFORMED BECAUSE THE CUSTOMER DID NOT SEND THE DEVICE BACK FOR FURTHER EVALUATION. THEREFORE, THE REPORTED EVENT COULD NOT BE CONFIRMED.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED VERATHON INC. REGARDING A GLIDESCOPE GVL 4 THAT HAS A CRACKED TIP. THE REPORTED EVENT WAS DISCOVERED AT THE DISINFECTION PROCESS. NO INJURY TO PATIENT IS ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    72447 GLIDESCOPE GVL 4 NONE CCW VERATHON MEDICAL (CANADA) ULC 0574-0001

    Patients

    Seq Age Sex Outcome Treatment
    1