Events

Retiro De Equipo (Recall) de Device Recall Voyant Open Fusion Device

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Applied Medical Resources Corp.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    71956
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2769-2015
  • Fecha de inicio del evento
    2015-07-31
  • Fecha de publicación del evento
    2015-09-15
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-11-20
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=139445
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    Electrosurgical, cutting & coagulation & accessories - Product Code GEI
  • Causa
    Potential to improperly characterize tissue within the jaws, which may result in nonoptimal power delivery.
  • Acción
    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
  • Modelo / Serial
    Model Number: EB040  Lot Numbers: 1243964, 1243975, 1244125  Model Number: EB040+ Lot Numbers: 1245512, 1245513, 1246241, 1246508, 1247079, 1247566, 1248102, 1249264
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - U.S Nationwide in the states of:FL, GA, NV. and countries of: France, Netherlands, Spain, and United Kingdom.
  • Descripción del producto
    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
  • Dirección del fabricante
    Applied Medical Resources Corp, 22872 Avenida Empresa, Rancho Santa Margarita CA 92688-2650
  • Empresa matriz del fabricante (2017)
    Applied Medical Corporation
  • Source
    USFDA