Events

Retiro De Equipo (Recall) de Device Recall SEDASYS

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 Ethicon Endo-Surgery 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
    71551
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-2374-2015
  • Fecha de inicio del evento
    2015-05-13
  • Fecha de publicación del evento
    2015-08-26
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-05-02
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=138180
  • 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
    Computer-assisted personalized sedation system - Product Code PDR
  • Causa
    Ethicon has found that disinfecting methods not specified in the instructions for use (ifu) have led to the degradation of the plastic material of the sedasys system control unit.
  • Acción
    Sedasys, a Division of Ethicon Endo-Surgery, Inc. sent an Urgent Customer Notification letter dated May 27, 2015, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to do the following: 1. Please distribute this information to all staff within your facility who use the SEDASYS System 2. Complete the Business Reply Form (BRF) (Attachment A) confirming receipt of this notice within three (3) business days. The BRF may be given to your sales or service representative or sent to Sedasys by email at SedasysTechSupport@its.jnj.com. 3. Keep this notice visibly posted in your facility for awareness. 4. If you have any questions or concerns regarding the condition of your SEDASYS System including the Control Units, please contact your Sales or Service Representative. If you need clinical or product support, please contact your local sales representative or call our Customer Support Center at 1-800-SEDASYS (1-800-733-2797). If you need additional communications packages, contact 1-800-SEDASYS and reference Event 052715SED01. For questions regarding this recall call 513-337-7439.

Device

Device Recall SEDASYS
  • Modelo / Serial
    Model #SEDPRU01
  • Clasificación del producto
    Anesthesiology Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution including OH, RI, TX & WA.
  • Descripción del producto
    SEDASYS Computer-Assisted Personalized Sedation System, SEDPRU01. || An integrated physiological monitoring and drug delivery system intended to provide physician-led teams with a means of administering 1% propofol (10 mg/mL) injectable emulsion to sedate patients > 18 (ASA I-II) undergoing esophagogastroduodenoscopy (EGD) and colonoscopy procedures. || Intended to provide physician-led teams with a means of administering 1% propofol (10 mg/mL) injectable emulsion to sedate patients > 18 (ASA I-II) undergoing esophagogastroduodenoscopy (EGD) and colonoscopy procedures.
  • Manufacturer
    Ethicon Endo-Surgery Inc

Manufacturer

Ethicon Endo-Surgery Inc
  • Dirección del fabricante
    Ethicon Endo-Surgery Inc, 4545 Creek Rd, Blue Ash OH 45242-2803
  • Empresa matriz del fabricante (2017)
    Johnson & Johnson
  • Source
    USFDA