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The Voyant Open Fusion device is a bipolar, electrosurgical device indicated for use with the Voyant electrosurgical generator in open procedures where the ligation and division of vessels and tissue bundles is desired. The device can seal and divide vessels up to and including 7mm in diameter and tissue bundles that can be captured in the jaws of the device.

The device has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures, and should not be used for these procedures.

Voyant® Open Fusion is an advanced bipolar instrument that uses radiofrequency (RF) energy, provided by the Voyant Electrosurgical Generator (Voyant ESG), to seal vessels up to and including 7mm in diameter. The device may also be used to seal tissue bundles that can be captured in the device jaws. Once the tissue is fused, the sealed tissue may be divided with a user-actuated blade to transect the tissue at the seal site.

The Voyant Open Fusion is comprised of three sections: jaws, shaft, and handle (including the cord and device plug). The subject device features a curved jaw with a tapered jaw design. The updated tapered jaw design does not change the device's intended function or user interface. The pistol-grip style handle features a knob, fuse button, trigger, and blade lever. The knob enables 180° rotation of Voyant Open Fusion device jaws. The trigger opens and closes the device jaws and can latch when the jaws are in the closed position. Squeezing the trigger again will release the latch and allow the jaws to open. The fuse button on the back of the handle activates RF energy. When the fuse button is pressed and held for the full seal cycle, RF output will automatically stop upon a complete seal, an audible tone will be heard and a message is displayed on the Voyant ESG screen. If the user releases the button prior to seal completion, RF output will be interrupted, an alarm tone will be heard and a message is displayed on the ESG screen. To transect the tissue, the user pulls the blade lever while the jaws are latched in the closed position.

The device connects to the Voyant ESG via a device plug and cord. The cord and device plug are attached to the device handle. The cord facilitates the transfer of RF energy from the ESG, through the handle, along the shaft, and to the jaws. The device plug has a distinct shape which enables a proprietary connection to the Voyant ESG.

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