Events

Retiro De Equipo (Recall) de Olympus GF-UCT180 Ultrasonic Gastrovideoscope

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
    19165
  • Fecha de inicio del evento
    2015-09-23
  • 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
    There is a risk of patient-to-patient infection if the device is not cleaned appropriately., key changes in the new instruction for use are highlighted below:, * inclusion of instruction on how to attach the cleaning adapter (maj-350) to the instrument channel port of the gf-uct180, * the balloon applicator (maj-675) and the cleaning brush (maj-1534) are to be reprocessed for reuse. the maj-675 and maj-1534 are to be reprocessed in accordance with the cleaning, disinfection, and sterilisation procedures for reusable parts and reprocessing equipment.
  • Acción
    Instructions for use to be updated

Device

Olympus GF-UCT180 Ultrasonic Gastrovideoscope

Manufacturer

Olympus Medical Systems Corporation