Events

Retiro De Equipo (Recall) de EndoWrist MCS Tip Cover Accessory

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 Intuitive Surgical, Inc..

¿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
    65073
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1425-2013
  • Fecha de inicio del evento
    2011-09-23
  • Fecha de publicación del evento
    2013-05-29
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-05-30
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=117837
  • 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
    System,surgical,computer controlled instrument - Product Code NAY
  • Causa
    Clarification of existing labeling and related cautions for the tip cover accessory of the da vinci surgical system.
  • Acción
    Intuitive Surgical sent an Important Product Notification letters dated October 10, 2011 to all affected customers. A second letter was sent to those that had not responded on December 4, 2011. The letters identified the affected product, problem, and actions to be taken, The letter included recommendations and suggestions for proper use and prevention of damage to the Tip cover during surgery. Also attachments include recommendations and further information for the following areas: avoid instrument collisions; carefully install tip cover; straighten wrist prior to removal; inspect cannula prior to use and do not exceed maximum monopolar cautery settings. Attached is a list of validated ESU settings and suggestions and instruction on being aware of critical anatomy in contact with the instrument and to change the tip cover in cases with extended cautery use. Questions may be referred to Customer service at 1-800-876-1310 in the US and at + 41 21 821 2020 or +800-0821-2010.

Device

EndoWrist MCS Tip Cover Accessory
  • Modelo / Serial
    Model numbers: 400180-10 and prior versions 400180-01, 400180-02, 400180-03, 400180-04, 400180-05, 400180-05, 400180-06. 400180-07, 400180-08 and 400180-09.
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution - USA Nationwide and the countries of Australia, Austria, Belgium, China, Czech Republic, Denmark, Finland, France, Germany, Greece, India, Ireland, Israel, Italy, Japan, Malaysia, Mexico, Netherlands, New Zealand, Norway, Pakistan, Philippines, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Slovenia, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom.
  • Descripción del producto
    Tip Cover Accessory, 8 MM, MCS, box of 10 || Product Usage: || The disposable Tip cover accessory is used in conjunction with the 8mm Monopolar Curved Scissors Instruments to cut and coagulate tissue. The tip cover is intended to provide electrical insulation over a section of the Monopolar Curved Scissors instrument so that FR energy is only available at the scissors blades.
  • Manufacturer
    Intuitive Surgical, Inc.

Manufacturer

Intuitive Surgical, Inc.
  • Dirección del fabricante
    Intuitive Surgical, Inc., 1266 Kifer Rd Bldg 100, Sunnyvale CA 94086-5304
  • Empresa matriz del fabricante (2017)
    Intuitive Surgical Inc
  • Source
    USFDA