Events

Retiro De Equipo (Recall) de Device Recall da Vinci S 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
    73649
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1377-2016
  • Fecha de inicio del evento
    2016-03-16
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-07-01
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=144663
  • 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
    Intuitive surgical has found that the use of instruments other than the cardiac probe grasper (e.G. large needle driver instrument) to manipulate the ablation probes during cardiac surgery can result in an increase of microscopic metallic particulates generated from the contact with the probes.
  • Acción
    Intuitive sent a Field Safety Notice/Urgent Medical Device Correction letters dated March 22, 2016 by trackable mail method to their customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to 1. In addition to existing instructions for use, observe the following warning when manipulating the cardiac ablation probe, Use only the Cardiac Probe Grasper to manipulate a cardiac ablation probe. 2. Distribute a copy of this letter to all da Vinci S, Si, and Xi users at your facility. 3. Place a copy of this letter with your user manual. 4. Complete the attached Acknowledgement Form and return it to Intuitive Surgical as instructed. 5. Retain a copy of this letter and the Acknowledgement Form for your files. Intuitive Surgical will provide a user manual addendum to incorporate the warning related to this risk. For questions contact your Clinical Sales Representative or contact Intuitive Surgical Customer Service.

Device

Device Recall da Vinci S Surgical System
  • Modelo / Serial
    Model number 551457- IS4000 English: Model number 551706 - IS4000 OUS
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US Nationwide in the countries Australia, Belgium, Brazil, Canada, Chile, Finland, France, Germany, Greece, Iceland, India, Israel, Italy, Netherlands, Qatar, Russia, Singapore, South Korea, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, and United Kingdom.
  • Descripción del producto
    da Vinci S Surgical System (IS4000) user manual English and OUS. || Product Usage: || The Intuitive Surgical Endoscope Instrument Control System (da Vinci Surgical System, Model IS4000) is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, forceps/pick-ups, needle holders, endoscopic retractors, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximations, ligation, electrocautery, suturing and delivery and placement of microware and cryogenic ablation probes and accessories, during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic laparoscopic surgical procedures, general thoracoscopic surgical procedures and thoracoscopically-assisted cardiotomy procedures. The system can also be employed with adjunctive mediastinotomy to perform coronary anastomosis during cardiac revascularization. The system is indicated for adult and pediatric use. It is intended to be used by trained physicians in an operating room environment in accordance with the representative, specific procedures set forth in the Professional Instructions for Use.
  • 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