Recall Z-2769-2015— Applied Medical Resources Corp

Name: FDA recall Z-2769-2015
Creator: U.S. Food and Drug Administration
Published: 2015-07-31

Class II · Terminated

Class II FDA medical device recall by Applied Medical Resources Corp, initiated 2015-07-31, terminated 2015-11-20. It names one FDA 510(k) clearance: K143517. 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.. Reason: Potential to improperly characterize tissue within the jaws, which may result in nonoptimal power delivery..

Recalling firm: Applied Medical Resources Corp
Classification: Class II
Status: Terminated
Initiated: 2015-07-31
Terminated: 2015-11-20
Firm location: Rancho Santa Margarita, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K143517 — Voyant Open Sealer-Divider DeviceApplied Medical Resources·cleared 2015-03-27

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product 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 for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.