Events

Retiro De Equipo (Recall) de Olympus TJF-Q180V Duodenovideoscope

Según New Zealand Medicines and Medical Devices Safety Authority, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en New Zealand que fue producido por Olympus Medical Systems Corporation.

¿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
    19704
  • Fecha de inicio del evento
    2016-02-01
  • País del evento
    New Zealand
  • Fuente del evento
    NZMMDSA
  • URL de la fuente del evento
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notas / Alertas
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Notas adicionales en la data
    Recalling Organisation: Olympus (NZ) Ltd, 15D Paul Matthews Road, Albany, Auckland
  • Causa
    Nature of correction.:, there will be:, 1. minor changes to parts around the forceps elevator to improve the tolerance, 2. minor changes to the reprocessing manual (the forceps elevator must be raised and lowered during the leakage testing and updated warnings for aer and reprocessing workflow), 3. changes to the operation manual (each tjf-q180v will be required to be returned to olympus for an annual inspection of the forceps elevator surrounding parts).
  • Acción
    Instructions for use to be updated

Device

Olympus TJF-Q180V Duodenovideoscope

Manufacturer

Olympus Medical Systems Corporation