Events

Retiro De Equipo (Recall) de HF Resection Electrode_TURis

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 Winter & Ibe GmbH.

¿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
    21721
  • Fecha de inicio del evento
    2017-07-25
  • 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
    The ifu has been updated to include new contraindications, warnings and safety information. the contraindications information have been added as a part of the fda guidance for "hysteroscopes and gynaecologic laparoscopes submission guidance for 510k". the warnings and safety information have been added as a result of an update to the iec 60601-1 3rd edition, standard requirements.
  • Acción
    Instructions for use to be updated

Device

HF Resection Electrode_TURis

Manufacturer

Olympus Winter & Ibe GmbH