BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GLIDESCOPE GVL 4

    MDR report key: 3000161 · Received February 14, 2013

    Report

    Report Number
    9615393-2013-00065
    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
    Removal / Correction Number
    Z-0478-2013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE RECEIVED THE DEVICE FOR FURTHER EVAL. SERVICE CONFIRMED THAT THE DEVICE HAS CRACKS. THE CRACKS WERE LOCATED ON THE LENS. A REPLACEMENT DEVICE WILL BE SENT TO THE CUSTOMER.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED VERATHON INC. REGARDING A GLIDESCOPE GVL 4 BLADE THAT HAS CRACKS. THIS BLADE IS PART OF A VOLUNTARY RECALL. THE DEVICE DID NOT FAIL DURING USE WITH A PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64612 GLIDESCOPE GVL 4 NONE CCW VERATHON MEDICAL (CANADA) ULC. 0574-0001

    Patients

    Seq Age Sex Outcome Treatment
    1