Events

Retiro De Equipo (Recall) de Device Recall Ureteroreno videoscope URFV2 and URFV2R

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
    75993
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1252-2017
  • Fecha de inicio del evento
    2016-12-12
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2018-02-27
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=151898
  • 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
    Endoscope, accessories, narrow band spectrum - Product Code NWB
  • Causa
    Olympus has received complaints regarding the breakage of the endoscope's insertion tube bending section during surgical procedures. some of these complaints are associated with tissue trauma, including perforation, and insertion tubes which were stuck inside the patient and had to be surgically removed.
  • Acción
    The firm, Olympus, sent an "Urgent Medical Device Safety Notice" on December 29, 2016, to those that were affected by this issue. The letter addressed the corrective actions Olympus were taking 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 and complete and return the OLYMPUS URGENT MEDICAL DEVICE SAFETY NOTIFICATION via fax to: Olympus Regulatory Affairs Department at 484-896-7128.

Device

Device Recall Ureteroreno videoscope URFV2 and URFV2R
  • Modelo / Serial
    All serial numbers
  • Clasificación del producto
    Gastroenterology-Urology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution-US Nationwide and country of: Canada.
  • Descripción del producto
    Uretero-reno videoscope URF-V2 and URF-V2R endoscope and accessories || The URF-V2/V2R endoscopes are intended for use in endoscopic diagnosis and treatment within the ureter and kidney.
  • Manufacturer
    Olympus Corporation of the Americas

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