Events

Retiro De Equipo (Recall) de Intuitive Surgical EndoWrist Instrument Hot Shears Monopolar Curved Scissors

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Device Technologies Australia Pty Ltd.

¿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
    RC-2013-RN-00522-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2013-05-29
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00522-1
  • Notas / Alertas
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Notas adicionales en la data
  • Causa
    Certain versions of the msc instruments may develop micro-cracks near the distal (scissor) end of the shaft following reprocessing. the manufacturer identified these micro-cracks during internal testing of an unrelated design modification. these micro-cracks may create a pathway for electrosurgical energy to lead to patient tissue during use and potentially cause thermal injury.
  • Acción
    Device Technologies is requesting their customers to follow work around instructions until alternative stock can be provided.

Device

Intuitive Surgical EndoWrist Instrument Hot Shears Monopolar Curved Scissors
  • Modelo / Serial
    Intuitive Surgical EndoWrist Instrument Hot Shears Monopolar Curved ScissorsPart numbers: 420179-09 and -10, 400179-09 and-10
  • Manufacturer
    Device Technologies Australia Pty Ltd

Manufacturer

Device Technologies Australia Pty Ltd