BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GLIDESCOPE GVL 3

    MDR report key: 3000139 · Received February 14, 2013

    Report

    Report Number
    9615393-2013-00062
    Event Type
    Malfunction
    Date Received
    February 14, 2013
    Date of Event
    January 16, 2013
    Report Date
    January 16, 2013
    Manufacturer
    VERATHON MEDICAL (CANADA) ULC.
    Product Code
    CCW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE RECEIVED THE DEVICE FOR FURTHER EVAL. SERVICE CONFIRMED THAT THE TIP OF THE BLADE IS BROKEN. A REPLACEMENT BLADE WAS SENT TO THE CUSTOMER.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED VERATHON INC. REGARDING A GLIDESCOPE GVL 3 BLADE TIP THAT IS BROKEN. THERE IS NO PT INJURY REPORTED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    65383 GLIDESCOPE GVL 3 NONE CCW VERATHON MEDICAL (CANADA) ULC. 0574-0007

    Patients

    Seq Age Sex Outcome Treatment
    1