Retiro De Equipo (Recall) de Intuitive Surgical laparoscopic instruments activated by da Vinci SiTM Single Site Grip Release mechanism

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
  • ID del evento
  • Fecha de inicio del evento
  • País del evento
  • Fuente del evento
  • 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
    Under rare circumstances, grip actuated instruments may become fixed in a closed position. this potential failure has been attributed to excessive force exerted on the instrument during insertion into a curved cannula, which may result in:, 1. a break in the roll gear and/or instrument shaft, 2. damage to the push/pull mechanism that controls grip opening and closing.
  • Acción
    Instructions for use to be updated


  • Modelo / Serial
    Model: 428050-12, 428050-13, 428050-14, 428053-12, 428053-15, 428055-12, 428055-13, 428056-12, 428056-13, 428058-12, 428058-13, 428059-12, 428059-13, 428080-04, 428080-05, 428088-12, 428088-13, 428093-12, 428093-13, Affected: All lots
  • Manufacturer