Device product
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.
Z-2769-2015
Product summary
- Event
- Event 71956
- Status
- Terminated
- Classification
- Class II
- Quantity
- 101 units (U.S) and 38 units (International)
- Official record key
device-enforcement:Z-2769-2015
Official wording
Reason: Potential to improperly characterize tissue within the jaws, which may result in nonoptimal power delivery.
Code information: Model Number: EB040 Lot Numbers: 1243964, 1243975, 1244125 Model Number: EB040+ Lot Numbers: 1245512, 1245513, 1246241, 1246508, 1247079, 1247566, 1248102, 1249264
Distribution pattern: Worldwide Distribution - U.S Nationwide in the states of:FL, GA, NV. and countries of: France, Netherlands, Spain, and United Kingdom.
Derived failure modes
-
Unknown
Potential to improperly characterize tissue within the jaws, which may result in nonoptimal power delivery.