Events

Retiro De Equipo (Recall) de Device Recall da Vinci Xi" Surgical System

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
    69638
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0430-2015
  • Fecha de inicio del evento
    2014-11-03
  • Fecha de publicación del evento
    2014-11-25
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-02-03
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=131215
  • 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
    Deviations in reprocessing steps from those stated in the reprocessing instructions can cause surface degradation of the housing and/or accelerate mechanical wear of the instrument.
  • Acción
    Urgent Medical Device Recall letters were sent to affected sites on November 3, 2014. Letters inform customers of the reason for recall, risk to health and the affected instrument. A table of all of the affected IS4000 instruments affected is attached to the letter indicating the part number and product name for each. Letters also inform customers that all instruments shipped since July 2014 are manufactured with a new material and not subject to recall. Customers are to take the following actions: 1. Ensure that all affected personnel are aware of the information. 2. Identify affected product in their possession 3. Contact ISI rep for replacement. 4. Complete and return the attached Acknowledgement From. Until replacement instruments are received, the old instruments may be used provided they do not show signs of degradation and that the reprocessing instructions are followed. Questions to 800-876-1310 Option 3 ( 6 am to 5 pm PST) or ics@intusurg.com.

Device

Device Recall da Vinci Xi" Surgical System
  • Modelo / Serial
    Part number:470093-04; All 8mm da Vinci Xi (IS4000) Surgical System instruments manufactured with white colored housings.
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    US Distribution -- FL, TX, NY, NV, OR, IN, UT, and MA.
  • Descripción del producto
    8MM,LONG TIP FORCEPS; || Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
  • 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