Events

Retiro De Equipo (Recall) de Device Recall STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit

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
    76754
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1727-2017
  • Fecha de inicio del evento
    2017-03-15
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=154123
  • 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 become aware and further investigation has determined that misinterpretation of instructions provided on the is4000 stapler release kit instruction card may result damage of the tool.
  • Acción
    Intuitive sent an Urgent Medical Device Correction (ISIFA2017-02-C) letter dated March 16, 2017 were sent by FED EX to be received on March 17, 2017. Letters advised users of the reason for the notification, risk to health, affected products with part numbers and a copy of Appendix A - proper use of the Stapler Release Kit (SRK). Customers were instructed to distribute a copy of the letter to all users at their facility, follow all instructions using the Instrument Release Kit (IRK) tool to finish manually unclamping the stapler and return the SRK to Intuitive Surgical through the Returned Material Authorization (RMA) process. Customers were also instructed to log into the da Vinci Online Community Field Action resource (US only) to read or complete any request actions related to this issue. In the case where the da Vinci online resource cannot be used (including outside he US), complete the attached Acknowledgement Form and return it via fax to Intuitive Surgical as instructed on the form. Customers were asked to retain a copy of the letter with their Stapler User Manual and the acknowledgement form for their files. If you need further information or support concerning this notification , please contact Intuitive Surgical Customer Service at the numbers listed below: ¿ North and South America: (800) 876-1310, Option 3 (4 AM to 5 PM PST) or mail: customersupport-servicesupport@intusurg.com ¿ Europe, Middle East, Asia and Africa: +800 0821 2020 or +41 21 821 2020 (8 AM to 6 PM CET) or ics@intusurg.com ¿ South Korea: 02-3271-3200 (9 AM to 6 PM KSTJ) ¿ Japan: 0120-56-5635 or 03-5575-1362 (9 AM to 6 PM JST) For questions regarding this recall call 408-523-2100.

Device

Device Recall STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit
  • Modelo / Serial
    Part number: 381402-01
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US (nationwide) and Internationally to Australia, Austria, Belgium, Canada, Chile, Colombia, Czech Republic, Denmark, Finland, France, Germany, Hong Kong, Ireland, Italy, Japan, Luxembourg, Monaco, Netherlands, Norway, Portugal, Puerto Rico, Singapore, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey, United Kingdom and Venezuela
  • Descripción del producto
    STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model number 470298. || da Vinci Xi Swedish SRK || General and Plastic Surgery: The Intuitive Surgical EndoWrist Stapler 45, Stapler 45 Reloads and other Stapler Accessories are intended to be used with the da Vinci¿ Xi Surgical System (Model IS4000) for resection, transection and/or creation of anastomoses in General, Thoracic, Gynecologic, and Urologic surgery. The device can be used with staple line or tissue butressing material (natural or synthetic).
  • 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