Retiro De Equipo (Recall) de Device Recall Vue Optic Visualization Source, Flexor Vue Deflecting Endoscopic 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 Cook 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
    77305
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2540-2017
  • Fecha de inicio del evento
    2017-05-03
  • Fecha de publicación del evento
    2017-06-05
  • Estado del evento
    Terminated
  • País del evento
  • Fecha de finalización del evento
    2018-01-26
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
  • 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
    image, illumination, fiberoptic, for endoscope - Product Code FFS
  • Causa
    Cook inc. is initiating a voluntary recall of the vue optic visualization source and the flexor vue deflecting endoscopic system because it was determined that the current reprocessing instructions do not provide sufficient detailed information for the cleaning, disinfection, and sterilization of these products.
  • Acción
    Cook Inc. initiated a voluntary recall of multiple products because it was identified that the reprocessing instructions do not provide sufficiently detailed information for the cleaning, disinfection, and sterilization of these products. Potential adverse events that may occur if the products are not adequately reprocessed include urological infections and systemic infections from a urological origin as well as events resulting from chemical residual exposure. Notices were mailed on 05/9/2017 via courier. Customers were asked to do the following: Distribution of the VueOptic Visualization Source and Flexor Vue Deflecting Endoscopic System products will not occur until the reprocessing instructions in the Instructions for Use have been corrected. You can continue to use the VueOptic Visualization Source and Flexor Vue Deflecting Endoscopic System by following the attached document for Reprocessing Instructions. Action to be taken: 1. Examine your inventory immediately to identify and quarantine those affected products. 2. Implement the provided updated Reprocessing Instructions. 3. Return the required Acknowledgement and Receipt Form within 30 days. 4. Even if you do not have affected products, you must still complete the Acknowledgement and Receipt Form and send it via fax (812.339.7316) or email (fieldactionsna@cookmedical.com). 5. Immediately report any adverse events to Cook Medical Customer Relations at 800.457.4500 or 812.339.2235, Monday through Friday between 7:30 am and 5:00 pm (Eastern Time), or by email at customerrelationsna@cookmedical.com. Adverse events or quality problems experienced with the use of this product may also be reported to the FDA: Online at: http://www.fda.gov/Safety/MedWatch/HowToReport/default.htm (form available to fax or mail) Call the FDA at: 1-800-FDA-1088 Should you have any medical questions or concerns, please contact Cook Medical Customer Relations at 800.457.4500 or 812.339.2235.

Device

  • Modelo / Serial
    Vue Optic Visualization Source, Catalog Number: FVO-150, GPN: G25343 Flexor Vue Deflecting Endoscopic System Catalog Number: FV-090075-150, GPN: G50972 Catalog Number: FV-090045-150, GPN: G34306
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Domestic: FL IN LA MS NC TX Foreign:Argentina, Australia, Brazil, Canada, Czech Republic, Egypt, Estonia, France, Germany, Israel, Italy, Netherlands, Norway, Paraguay, Poland, Portugal, Russian Federation, Spain, Switzerland, Tunisia, Turkey, United Kingdom, VA/DOD:None
  • Descripción del producto
    Vue Optic Visualization Source, Flexor Vue Deflecting Endoscopic System, Endoscope, Fiber Optic, Supplied sterilized by ethylene oxide gas in peel-open packages
  • Manufacturer

Manufacturer

  • Dirección del fabricante
    Cook Inc., 750 N Daniels Way, Bloomington IN 47404-9120
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA