Events

Retiro De Equipo (Recall) de Ethicon Electrosurgery Probe Plus II with Electrode

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 Ethicon Endo-Surgery 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
    14564
  • Fecha de inicio del evento
    2013-04-26
  • 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: Johnson & Johnson Medical New Zealand Ltd, 507 Mt Wellington Highway, Mt Wellington, AUCKLAND 1060
  • Causa
    There is a potential for edge of the probe plus ii rotational knob to rub against the tyvek(r) and in remote instances puncture the tyvek(r) creating a pin hole. due to the possibility that a tear in the tyvek(r) packaging may compromise the sterility of the device the stated setrility levels could not be assured for the product. the endopath probe pluss ii shaft is sold and labelled as "sterile".
  • Acción
    Product to be returned to supplier

Device

Ethicon Electrosurgery Probe Plus II with Electrode

Manufacturer

Ethicon Endo-Surgery Inc