Events

Retiro De Equipo (Recall) de Endowrist Instruments and Accessories for the da Vinci Surgical Systems (Used in endoscopic procedures)

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-00890-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2013-08-22
  • 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-00890-1
  • 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 are implementing a revised reprocessing instructions for endowrist instruments and accessories.The changes include:- to allow the use of mildly alkaline enzymatic cleaners, instead of only ph-neutral enzymatic cleaners.- to clarify soaking prior to active scrubbing and rinsing in order to soften soil and make pre-cleaning easier.- to augment scrubbing by spraying water through the isi-supplier luer nozzle at 2 bar pressure onto the tip of the instrument.- to add magnification to the visual inspection of instruments to make it easier to ensure that instruments are free of visible soil prior to automated reprocessing.
  • Acción
    Device Technologies Australia is providing on site training for the revised instructions, review updated content and provide a Cleaning and Sanitation kit (including the revised instructions) for all users.

Device

Endowrist Instruments and Accessories for the da Vinci Surgical Systems (Used in endoscopic proce...
  • Modelo / Serial
    Endowrist Instruments and Accessories for the da Vinci Surgical Systems (Used in endoscopic procedures)Part Numbers of Affected Reprocessing Instructions: 550874-02 and 550882-05ARTG Number: 132451
  • Manufacturer
    Device Technologies Australia Pty Ltd

Manufacturer

Device Technologies Australia Pty Ltd