Events

Retiro De Equipo (Recall) de Device Recall EndoWrist

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
    37436
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0660-2007
  • Fecha de inicio del evento
    2005-03-24
  • Fecha de publicación del evento
    2007-03-28
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2007-11-28
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=50550
  • 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
    surgical instrument - Product Code NAY
  • Causa
    The products were incorrectly programmed as training instruments, which allows for 30 uses (surgical procedures) instead of 10 uses.
  • Acción
    The firm initiated its recall in March 24, 2005, when the firm sent a letter via Federal Express mail to all 18 consignees, informing them of the issue, how to identify affected product, and instructions to return the affected instruments for a full credit. The form included a reply form that consignees were requested to fill out and return.

Device

Device Recall EndoWrist
  • Modelo / Serial
    The 8mm EndoWrist Bipolar Maryland Instrument is manufactured in lots, and traceability is maintained for each lot. A two digit unique identifier is added to the lot number label on the instruments, and programming records are traceable to these identifiers. The following 8 instruments from lot # 0503051 are affected:  0503051 66, 0503051 67, 0503051 68, 0503051 69, 0503051 70, 0503051 71, 0503051 72, and 0503051 73.
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Product was distributed to 12 consignees in the US, who received 19 instruments, in FL, IN, LA, MN, NC, NH, NJ, NY, TN and TX. In addition, 5 consignees outside the US received product as well, in Italy, Sweden, France, Singapore and Germany.
  • Descripción del producto
    8mm EndoWrist Bipolar Maryland Instrument, Part Number: 400172-04, || Distributed and Manufactured by Intuitive Surgical, Inc. 950 Kifer Road Sunnyvale, CA
  • Manufacturer
    Intuitive Surgical, Inc.

Manufacturer

Intuitive Surgical, Inc.
  • Dirección del fabricante
    Intuitive Surgical, Inc., 950 Kifer Rd, Sunnyvale CA 94086-5206
  • Source
    USFDA