Events

Retiro De Equipo (Recall) de Intuitive Surgical Inc. – 5mm Curved Cannula for Single-Site Instruments for da Vinci Surgical Systems

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-2014-RN-00520-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-05-12
  • 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-2014-RN-00520-1
  • 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
    Device technologies australia (dta) in conjunction with the manufacturer, intuitive surgical inc., is issuing this recall for product correction for 5mm curved cannula for single-site instruments, to update the user manual. as indicated in the user manual addendum, cannula damage can include cracks in the tube or bowl/tube interface and tube wall anomalies etc and may result from incorrect placement of the cannulae. if cannula damage occurs during a procedure, then there is a possibility that the cannula or associated instrument may come in inadvertent contact with tissue and generate excessive forces on the patient body wall. this contact may cause tissue injury and require additional surgical and/or medical intervention.
  • Acción
    The “Single-Site Cannula Inspection and Use – Single-Site User Manual Addendum” will be hand delivered to the Nurse Unit Manager by your Product Specialist.

Device

Intuitive Surgical Inc. – 5mm Curved Cannula for Single-Site Instruments for da Vinci Surgical Sy...
  • Modelo / Serial
    Intuitive Surgical Inc. – 5mm Curved Cannula for Single-Site Instruments for da Vinci Surgical SystemsAffected Products:INS-428061 5 X 300MM CURVED CANNULA ARM 1INS-428062 5 X 300MM CURVED CANNULA ARM 2INS-428071 5 X 250MM CURVED CANNULA ARM 1INS-428072 5 X 250MM CURVED CANNULA ARM 2ARTG Number: 97289
  • Manufacturer
    Device Technologies Australia Pty Ltd

Manufacturer

Device Technologies Australia Pty Ltd