Events

Retiro De Equipo (Recall) de Device Recall IS3000 da Vinci Si" 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
    69902
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0940-2015
  • Fecha de inicio del evento
    2014-12-05
  • Fecha de publicación del evento
    2015-01-07
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-03-03
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=131929
  • 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 is initiating a voluntary correction related to da vinci si system (is3000) vision side carts, with threaded-in caster wheels, which can result in the caster wheel bolts gradually unthreading and the wheels loosening.
  • Acción
    The firm, Intuitive Surgical, sent an "Urgent Medical Device Correction" letter dated December 5, 2014 to all customers on December 5, 2014 by trackable method. The letter described the product, problem and actions to be taken. The customers were instructed to: ensure all affected personnel are fully informed of this notice; identify affected product, and retain a copy of this notice with your da Vinci Si user manual. Please note: the da Vinci Si Vision Side Cart can continue to be used safely. Ensure that all wheels are fully unlocked before attempting to move the Vision Side Cart. Avoid rolling the Vision Side Cart over uneven surfaces (i.e., over cables or a threshold). Intuitive Surgical is working on a newly designed wheel assembly. Upon availability, Field Service will retrofit the wheel assembly of the affected Vision Side Carts with the new design. 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: 8008761310 Option 3 (6 a.m. to 5 p.m. PST) ¿¿ Japan: 0120565635 or 0355751362 (9 a.m. to 6 p.m. JST) ¿¿ South Korea: 0232713200 (9 a.m. to 6 p.m. KST) ¿¿ Europe, Middle East, Asia and Africa: +800 0821 2020 or +41 21 821 2020 (8 a.m. to 6 p.m.) or ics@intusurg.com

Device

Device Recall IS3000 da Vinci Si" Surgical System
  • Modelo / Serial
    Product number 371683-05/Model Number VS3000 Serial numbers - USA: SH0018, SH0057, SH0097, SH0132, SH0165, SH0235, SH0019, SH0058, SH0098, SH0133, SH0167, SH0248, SH0021, SH0059, SH0099, SH0134, SH0168, USG015, SH0024, SH0060, SH0100, SH0135, SH0169, USG072, SH0025,SH0064, SH0101, SH0136, SH0170, USG146, SH0026, SH0065, SH0102, SH0137,SH0171, USG213, SH0029, SH0066, SH0103, SH0138, SH0172, USG317, SH0030, SH0067, SH0104, SH0139, SH0175, USG352, SH0031, SH0068, SH0105, SH0140, SH0177, USG353, SH0032, SH0069, SH0106 ,SH0141, SH0179 ,USG445, SH0033, SH0070, SH0107, SH0142, SH0180, USG519, SH0035, SH0071, SH0109, SH0143, SH0182, USG559, SH0036, SH0072, SH0110, SH0144, SH0184, USG631,SH0038, SH0073, SH0112, SH0145, SH0185, USG700, SH0039, SH0076, SH0113, SH0146, SH0186, USG701,SH0040, SH0077, SH0115, SH0147, SH0187, USG702, SH0041, SH0078, SH0117, SH0149, SH0188 ,USG703, SH0042, SH0079, SH0118, SH0150, SH0189, USG721, SH0044, SH0080, SH0119, SH0151, SH0190 ,USG728, SH0045, SH0081, SH0120, SH0152, SH0194, USG748, SH0046, SH0082, SH0121, SH0153, SH0196, USG750, SH0047, SH0085, SH0123, SH0154, SH020,2 USG764, SH0048, SH0088, SH0124, SH0155, SH0203, USG769, SH0050, SH0089, SH0125, SH0156, SH0204, USG770, SH0051 SH0090 SH0126 SH0157 SH0206 USG775, SH0052, SH0091, SH0127, SH0158, SH0211, USG786, SH0053, SH0092, SH0128, SH0159, SH0215,, USG787, SH0054, SH0094, SH0129, SH0160, SH0216, USG788, SH0055, SH0095, SH0130, SH0163, SH0223, SH0056, SH0096, SH0131, SH0164, SH0224, Out of US: SH0034,USG217, SH0086, SH0087, SH0028,SH0084,SH0111, SH0191, USG754, SH0114, SH0116, SH0063, SH0148, USG484, USG727, SH0161, SH0162, SH0061, SH0093, SH0238, USG726, SH0062, SH0037, USG806.
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution: US (nationwide) and countries of: Belgium, France, Germany, Romania, India, Israel, Italy, South Korea, Norway, Slovak Republic, Spain, Sweden, Turkey, and United Kingdom.
  • Descripción del producto
    IS3000 Vision Side Cart (VSC) used in conjunction with the da Vinci Si Surgical System IS3000. || Product number 371683-05/Model Number VS3000 || The Intuitive Surgical Endoscopic Instrument Control System (Intuitive Surgical da Vinci Surgical System Model IS3000) is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, ultrasonic shears, forceps/pick-ups, needle holders, endoscopic retractors, stabilizers, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, and delivery and placement of microwave and cryogenic ablation probes and accessories, during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic laparoscopic surgical procedures, general cardiovascular and noncardiovascular 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