BEUDAMED
    FDA Enforcement Class II Terminated

    Voyant Open Fusion Device Models: EB040 and EB040+ Product Usage: The Applied Voyant Open Fusion Device is designed for use with the Voyant Electrosurgical Generator. The device is an advanced bipolar instrument that uses RF energy, provided by the generator, to seal vessels up to and including 5mm (EB040+) or 7mm (EB040) in diameter. The device may also be used to seal tissue bundles that can be captured in the device jaws. The system delivers the energy required to fuse the tissue between the jaws of the device by monitoring voltage and current throughout the seal cycle. The device also features a useractuated blade for the transection of sealed tissue.

    Recall: Z-2769-2015 · Reported September 23, 2015

    Enforcement

    Recall Number
    Z-2769-2015
    Event ID
    71956
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Applied Medical Resources Corp
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 23, 2015
    Initiation Date
    July 31, 2015
    Classification Date
    September 15, 2015
    Termination Date
    November 20, 2015
    Address
    22872 Avenida Empresa, Rancho Santa Margarita, CA, 92688-2650, United States

    Description

    Voyant Open Fusion Device Models: EB040 and EB040+ Product Usage: The Applied Voyant Open Fusion Device is designed for use with the Voyant Electrosurgical Generator. The device is an advanced bipolar instrument that uses RF energy, provided by the generator, to seal vessels up to and including 5mm (EB040+) or 7mm (EB040) in diameter. The device may also be used to seal tissue bundles that can be captured in the device jaws. The system delivers the energy required to fuse the tissue between the jaws of the device by monitoring voltage and current throughout the seal cycle. The device also features a useractuated blade for the transection of sealed tissue.

    Reason

    Potential to improperly characterize tissue within the jaws, which may result in nonoptimal power delivery.

    Code Info

    Model Number: EB040 Lot Numbers: 1243964, 1243975, 1244125 Model Number: EB040+ Lot Numbers: 1245512, 1245513, 1246241, 1246508, 1247079, 1247566, 1248102, 1249264

    Distribution

    Worldwide Distribution - U.S Nationwide in the states of:FL, GA, NV. and countries of: France, Netherlands, Spain, and United Kingdom.

    Quantity

    101 units (U.S) and 38 units (International)