Events

Retiro De Equipo (Recall) de URETERO-RENO FIBERSCOPE

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por OLYMPUS CANADA 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
    71582
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2016-12-22
  • País del evento
    Canada
  • Fuente del evento
    HC
  • Notas / Alertas
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Notas adicionales en la data
  • Causa
    The manufacturer olympus medical systems corp (omsc) has initiated this corrective action following complaints on the urf-p6/p6r insertion tube and breaks of the bending tube. these complaints have not resulted in any known adverse event. the urf-p6/p6r endoscopes are intended for use in endoscopic diagnosis and treatment within the ureter kidney and biliary tract (common bile duct and hepatic duct). omsc is aware of adverse events on the urf-v2/v2r endoscopes which have a similar structure to the urf-p6/p6r endoscopes. olympus is providing a two-page instructions for safe use to remind customers of inspection instructions in the existing operation manual and also provide pictures and instructions to assist in performing the inspection.

Device

URETERO-RENO FIBERSCOPE
  • Modelo / Serial
    Model Catalog: URF-P6 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: URF-P6R (Lot serial: ALL SERIAL NUMBERS)
  • Descripción del producto
    URETERO-RENO FIBERSCOPE
  • Manufacturer
    OLYMPUS CANADA INC.

Manufacturer

OLYMPUS CANADA INC.
  • Dirección del fabricante
    RICHMOND HILL
  • Empresa matriz del fabricante (2017)
    Olympus Corporation
  • Source
    HC