Events

Retiro De Equipo (Recall) de 5mm and 8mm Harmonic ACE Instruments IFU (for use with 5mm Harmonic ACE instruments (PNs 400274 and 400275) 8mm Harmonic ACE instruments (PNs 420274 and 420275) and Harmonic ACE Curved Shears Disposable Insert (PN 400272) used with the da Vinci Standard, S, and Si 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-2015-RN-00114-1
  • Clase de Riesgo del Evento
    Class III
  • Fecha de inicio del evento
    2015-02-17
  • 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-2015-RN-00114-1
  • 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 is informing the customers: intuitive surgical has found that the harmonic ace ifu used with the da vinci standard, s, and si surgical systems, contains incorrect instructions in regard to the proper use of the ininstrument release kit (irk) (or “emergency grip release allen wrench”). the harmonic ace ifu instructs the user to turn the irk counterclockwise. the correct instruction is to turn the irk clockwise.
  • Acción
    Device Technologies Australia (DTA) is requesting the users to discard the currentHarmonic ACE IFUs and to follow the instructions from the Instrument and Accessories User Manual, section 9.1. Introduction, paragraph General Precautions and Warnings; that is attached to the system.

Device

5mm and 8mm Harmonic ACE Instruments IFU (for use with 5mm Harmonic ACE instruments (PNs 400274 a...
  • Modelo / Serial
    5mm and 8mm Harmonic ACE Instruments IFU (for use with 5mm Harmonic ACE instruments (PNs 400274 and 400275) 8mm Harmonic ACE instruments (PNs 420274 and 420275) and Harmonic ACE Curved Shears Disposable Insert (PN 400272) used with the da Vinci Standard, S, and Si Surgical Systems. Model Numbers: 550635-01; 550635-02; 550635-03; 550635-04
  • Manufacturer
    Device Technologies Australia Pty Ltd

Manufacturer

Device Technologies Australia Pty Ltd