Events

Retiro De Equipo (Recall) de Device Recall URFP6 Ureteroreno fiberscope and URFP6R Ureteroreno fiberscope

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 Olympus Corporation of the Americas.

¿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
    75990
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1251-2017
  • Fecha de inicio del evento
    2016-12-12
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2018-02-26
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=151891
  • 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
    Choledochoscope and accessories, flexible/rigid - Product Code FBN
  • Causa
    Olympus is recalling the urf-p6/p6r endoscopes due to a similar device (urf-v2/v2r endoscopes) but not identical, where adverse event complaints associated with tissue trauma, perforation and insertion tubes which were stuck inside of patients that had to be surgically removed. in an effort to mitigate a potential risk to patient health, olympus is undertaking this action to notify users of these complaints and the need for careful inspection of the endoscope prior to use in accordance with the instructions provided int heir notification letter.
  • Acción
    Olympus sent an Urgent Medical Device Safety Notice dated December 29, 2016, to those that were affected by this issue. The letter addressed the corrective actions Olympus that were taken to address the issue. Consignees were asked to inspect their inventory for the specified device, review the enclosed Instructions for Safe Use, which provided instructions to assist with understanding the Warnings and Cautions. You can contact our Technical Assistance Center (TAC) at 1-(800) 848-9024, option 1, to answer any questions.

Device

Device Recall URFP6 Ureteroreno fiberscope and URFP6R Ureteroreno fiberscope

Manufacturer

Olympus Corporation of the Americas
  • Dirección del fabricante
    Olympus Corporation of the Americas, 3500 Corporate Pkwy, PO Box 610, Center Valley PA 18034-0610
  • Empresa matriz del fabricante (2017)
    Olympus Corporation
  • Source
    USFDA