Events

Recall of Device Recall Voyant Open Fusion Device

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Applied Medical Resources Corp.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    71956
  • Event Risk Class
    Class 2
  • Event Number
    Z-2769-2015
  • Event Initiated Date
    2015-07-31
  • Event Date Posted
    2015-09-15
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-11-20
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=139445
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Electrosurgical, cutting & coagulation & accessories - Product Code GEI
  • Reason
    Potential to improperly characterize tissue within the jaws, which may result in nonoptimal power delivery.
  • Action
    The firm sent out customer notification letters to International customers the beginning of July 31st, 2015 and domestic customers the week of August 3rd, 2015. The firm's letter requested customers complete the following actions: - check inventory for recalled product - complete the attached Recall Notification Confirmation Form to acknowledge the recall and indicate if facility is returning or has already used any of the products - Return the confirmation form(s) to Applied Medical by emailing to recall60669166@appliedmedical.com or faxing to (949) 713-8936. - Return affected product and a copy of the confirmation form(s) to Applied Medical For product return questions contact Karen Mitchell, Sales Operations Supervisor, RGA Dept. at (949) 713-8622 or by e-mail at kmitchell@appliedmedical.com. For regulatory questions contact Lauren Contursi, at (949) 713-8767 or by e-mail at lcontursi@appliedmedical.com.

Device

Device Recall Voyant Open Fusion Device
  • Model / Serial
    Model Number: EB040  Lot Numbers: 1243964, 1243975, 1244125  Model Number: EB040+ Lot Numbers: 1245512, 1245513, 1246241, 1246508, 1247079, 1247566, 1248102, 1249264
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - U.S Nationwide in the states of:FL, GA, NV. and countries of: France, Netherlands, Spain, and United Kingdom.
  • 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.
  • Manufacturer
    Applied Medical Resources Corp

Manufacturer

Applied Medical Resources Corp
  • Manufacturer Address
    Applied Medical Resources Corp, 22872 Avenida Empresa, Rancho Santa Margarita CA 92688-2650
  • Manufacturer Parent Company (2017)
    Applied Medical Corporation
  • Source
    USFDA