BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GLIDESCOPE GVL 4

    MDR report key: 3004325 · Received February 13, 2013

    Report

    Report Number
    9615393-2013-00055
    Event Type
    Malfunction
    Date Received
    February 13, 2013
    Date of Event
    January 15, 2013
    Report Date
    January 15, 2013
    Manufacturer
    VERATHON MEDICAL (CANADA) ULC
    Product Code
    CCW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE HAS NOT BEEN REC'D FOR EVAL. EVAL RESULTS ARE PENDING ANALYSIS OF THE PRODUCT.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED VERATHON INC. REGARDING A GLIDESCOPE GVL 4 BLADE THAT IS CRACKED AT THE TIP NEAR THE CAMERA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    63801 GLIDESCOPE GVL 4 NONE CCW VERATHON MEDICAL (CANADA) ULC 0574-0001

    Patients

    Seq Age Sex Outcome Treatment
    1