Events

Retiro De Equipo (Recall) de 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
    75473
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0315-2017
  • Fecha de inicio del evento
    2016-10-05
  • Fecha de publicación del evento
    2016-10-26
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-05-01
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=150460
  • 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 identified a software anomaly in the da vinci xi p5 software that can result in unexpected master movement and potential instrument tip movement under certain circumstances.
  • Acción
    Urgent Medical Device Correction letters were sent on October 12, 2016 by traceable method to all affected customers. Letters notify customers of the issue and provided instructions to prevent it from happening until ISI software can install new software upgrade in 1st Q 2017.

Device

da Vinci Xi" Surgical System
  • Modelo / Serial
    All systems manufactured with or upgraded to P5 software.
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Australia, Austria, Belgium, Colombia, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Hong Kong, India, Ireland, Israel, Italy, Japan, Monaco, Netherlands, Norway, Portugal, Puerto Rico, Qatar, Romania, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey, United Kingdom, United States
  • Descripción del producto
    da Vinci¿ Xi" Surgical System, model number IS4000, A70_P5x with P5 Software; || General and Plastic Surgery: || 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.
  • 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