Events

Retiro De Equipo (Recall) de Intuitive Surgical Battery Box of the da Vinci STM and da Vinci SiTM 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-00892-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-09-02
  • 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-00892-1
  • 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
    Patient side cart battery boxes returned to intuitive surgical from the field have revealed, in some rare charging conditions, the battery has been found to heat sufficiently to cause the battery case to bulge. a battery case that has bulged has the potential to release some of its internal gases to the surrounding air. the da vinci stm and da vinci sitm surgical systems are designed to detect overheating batteries and issue a system warning, error code 808 is displayed on the surgeon console and patient side cart monitors. when this event is detected, the system disables the charging of the battery until it cools down.
  • Acción
    Users are advised that they may continue to use their da Vinci S, Si and Si-e Patient Side Carts. However, if users receive an Error Code 808, or experience a sulfur odour while using da Vinci STM or da Vinci SiTM Surgical System, they are advised to contact their Device Technologies representative, following standard troubleshooting process. For product already in use, Device Technologies is utilising standard repair and preventative maintenance programs to monitor battery performance and perform battery replacement as needed. This action has been closed-out on 06/06/2016.

Device

Intuitive Surgical Battery Box of the da Vinci STM and da Vinci SiTM Surgical Systems
  • Modelo / Serial
    Intuitive Surgical Battery Box of the da Vinci STM and da Vinci SiTM Surgical SystemsProduct number for the battery box: 371268-02 Manufactured between 22 November 2005 and 09 July 2012ARTG Number: 97348
  • Manufacturer
    Device Technologies Australia Pty Ltd

Manufacturer

Device Technologies Australia Pty Ltd