Events

Retiro De Equipo (Recall) de Intuitive Surgical Endowrist Instruments Hot Shears- Monopolar Curved Scissors

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
    14736
  • Fecha de inicio del evento
    2013-05-30
  • 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: Device Technologies New Zealand, 47 Arrenway Drive, Albany, AUCKLAND 0632
  • Causa
    Manufacturer has identified a potential for some units of the monopolar curved scissors (mcs) to develop very small cracks.("micro-cracks") near the distal (scissor) end. this may create a pathway for electrosurgical energy to leak to tissue and potentially cause thermal injury. there is alos a risk that procedure time may be increased if the device needs to be replaced during surgery.
  • Acción
    Product to be returned to supplier

Device

Intuitive Surgical Endowrist Instruments Hot Shears- Monopolar Curved Scissors

Manufacturer

Intuitive Surgical Inc