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
    70705
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1304-2015
  • Fecha de inicio del evento
    2015-03-03
  • Fecha de publicación del evento
    2015-03-20
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-09-08
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=134526
  • 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
    Correction due to a fault that causes distal suj (dsuj) failures that indicates a mismatch between the positions reported by the redundant position sensors on one of the patient cart arm joints.
  • Acción
    The firm, Intuitive Surgical, sent an "Urgent Medical Device Correction" letter dated March 11, 2015 to its consignees/customers on March 11, 2015 via Fed Ex. The letter described the product, problem and actions to be taken. The customers were instructed to ensure that all affected personnel are fully informed of this notice; forward this notice to your Risk Manager, OR Director, Purchasing Manager, biomedical Engineering staff and members of your medical staff who perform da Vinci Surgery procedures; Identify systems containing affected product at your site; if you encounter this error during a procedure and the fault cannot be recovered, disable the affected arm and contact dVStat; Contact Intuitive Surgical Customer Service; Complete and return the attached Acknowledgment Form to Intuitive Surgical via U.S. Fax +1 (408) 716-3040, or Scan and Email: isi.compliance@intusurg.com, ATTN: REGULATORY COMPLIANCE-Subject line for email: Pot to Encoder;and retain a copy of this notice for your records. An Intuitive Surgical representative will contact you to schedule a remote assessment to determine the health of your system and to schedule an appointment to replace the affected arm. If you need further information or support concerning this Medical Device Correction, please contact your Clinical Sales Representative or Intuitive Surgical Customer Service at the numbers listed below: -North America and South America: 800-876-1310, Option 3 (6 AM to 5 PM PST) -Japan: 0120-56-5635 or 03-5575-1362 (9 AM to 6 PM JST) -South Korea: 02-3271-3200 (9 AM to 6 PM KST) -Europe, Middle East, Asia and Africa: +800 0821 2020 or +41 21 821 2020 (8 AM to 6 PM CET) or ics@intusurg.com.

Device

Device Recall da Vinci Xi Surgical System
  • Modelo / Serial
    Material number: 380647-20; Serial numbers: 1311140430, 1311140586, 1311140058, 1311140392. 1311140277, 1311140307, 1311140094, 1311140100, 1311140569, 1311140102, 1311140421, 1311140092, 1311140009, 1311140070, 1311140267, 1311140333, 1311140492, 1311140391, 1311140057, 1311140294, 1311140508, 1311140565, 1311140105, 1311140122, 1311140469, 1311140521, 1311140378, 1311140456, 1311140230 1311140573, 1311140065, 1311140164, 1311140194, 1311140511, 1311140291, 1311140304, 1311140212, 1311140222, 1311140001, 1311140137, 1311140344, 1311140381, 1311140341, 1311140538, 1311140168, 1311140523, 1311140274, 1311140033, 1311140091 1311140248, 1311140141, 1311140436, 1311140418, 1311140548 1311140320, 1311140170, 1311140346. Material number 380746-22: Serial numbers: 1311140486 1311140539, 1311140174, 1311140183, 1311140327, 1311140347 1311140482, 1311140145, 1311140066, 1311140302, 1311140477 1311140084, 1311140211, 1311140103, 1311140083, 1311140050, 1311140488, 1311140365, 1311140207, 1311140459, 1311140557,  1311140423, 1311140045, 1311140440, 1311140231.
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution: US (nationwide) and countries of: Australia, Belgium, China, France, Germany, India, Israel, Italy, Norway, South Korea, Spain, Sweden, Switzerland, Turkey, and United Kingdom.
  • Descripción del producto
    da Vinci Xi Surgical System, IS4000; || ASSY,USM,IS4000, || Material number: 380647-20 and 380647-22 || The Intuitive Surgical Endoscope Instrument Control System (da Vinci Surgical System, Model IS4000) is intended to assist in the accurate control of Intuitive Surgical Endocopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, forceps/pick-ups, needle holders, || endscopic retractors, electrocautery and accessories for edoscopic 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 labaroscopic surgical procedures, general thorascopic surgical procedures and thorascopically-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