Events

Retiro De Equipo (Recall) de HiRes 90K

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 Advanced Bionics Corporation.

¿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
    63353
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0117-2013
  • Fecha de inicio del evento
    2007-09-14
  • Fecha de publicación del evento
    2012-10-22
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-10-22
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=113560
  • 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
    Implant, cochlear - Product Code MCM
  • Causa
    Advanced bionics is recalling the the hires 90k cochlear implant with hifocus helix electrode because of loose-fitting insertion tool assemblies.
  • Acción
    The firm, Advanced Bionics, sent a " RECALL NOTIFICATION" letter dated September 14, 2007 to all their customers who purchased the HiRes 90K devices with Helix Electrodes Model CI 1400-02H. The letter identified the product, problem, and actions to be taken. The customers were instructed to immediately locate and return the affected product to Advanced Bionics. The firm's Service representative will contact the customers within 48 hours to retrieve the affected product and send a replacement as needed. The customers were also instructed to complete and return the enclosed Notification Acknowledgement form via fax to: (661) 362-1511. If you have any questions regarding this letter, call Advanced Bionics at (877) 829-0026 between the hours of 5 AM and 5 PM Pacific Time, Monday through Friday.

Device

HiRes 90K
  • Modelo / Serial
    Serial Numbers:  351323, 251153, 350989, 351226, 350196, 351136, 350140, 350201, 351261, 351264, 351266, 351269, 351412, 351415, 351429, 350157, 351303.
  • Clasificación del producto
    Ear, Nose, and Throat Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    Yes
  • Distribución
    Worldwide distribution: USA (nationwide) including state: IL and country of: Europe.
  • Descripción del producto
    HiRes 90K devices with Helix Electrodes Model CI 1400-02H || The HiResolution Bionic Ear System is a cochlear implant system designed to provide useful hearing to individuals with severe to profound hearing loss. It consists of internal and external components. The internal components include a stimulator (HiRes90K ICS) and electrode array (HiFocus 1j or Helix). The HiRes90K ICS is implanted surgically under the skin behind the ear. The electrode array is inserted into the cochlea. The external components include a sound processor (body-worn or ear-level), a headpiece, and a cable. The system converts sound into electrical energy that activates the auditory nerve. The auditory nerve then sends information to the brain, where it is interpreted as sound. The Helix consists of a fantail, electrode lead, and Helix electrode array. The electrode, comprised of platinum-iridium wires, is housed in a silicone carrier and extends from the titanium case. The Helix electrode array is 24.5 mm in length and is designed to be inserted approximately 18-21 mm into a normal patent cochlea. It consists of 16 planar contacts arranged along the medial surface of the electrode array for stimulation of discrete segments of the cochlea. The Helix electrode insertion tool is designed to assist the surgeon with the insertion of the Helix electrode. Only the Helix insertion should be used for insertion of the Helix electrode; the use of other instruments may result in damage to the electrode. The insertion tool is a single-use instrument.
  • Manufacturer
    Advanced Bionics Corporation

Manufacturer

Advanced Bionics Corporation
  • Dirección del fabricante
    Advanced Bionics Corporation, 12740 San Fernando Rd, Bldgs. 1 & 3, Sylmar CA 91342
  • Source
    USFDA