Retiro De Equipo (Recall) de Intuitive Large and Mega Needle Driver Endowrist Instruments

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 Intuitive Surgical 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
    15849
  • Fecha de inicio del evento
    2013-12-11
  • País del evento
  • Fuente del evento
    NZMMDSA
  • URL de la fuente del evento
  • 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: Device Technologies New Zealand, 47 Arrenway Drive, Albany, AUCKLAND 0632
  • Causa
    Intuitive surgical has become aware of the potential for detachment of the jaw insert for large needle drivers and mega needle drivers. if a jaw insert detaches during surgery, this could result in a device fragment falling into the patient.
  • Acción
    Product to be returned to supplier

Device

  • Modelo / Serial
    Model: Models: INS-420006, INS-420194, INS-400006, INS-400194, Affected: Manufactured between July 2007 and October 2011
  • Manufacturer

Manufacturer