Events

Recall of Intuitive Surgical Battery Box of the da Vinci STM and da Vinci SiTM Surgical Systems

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Device Technologies Australia Pty Ltd.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    RC-2014-RN-00892-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2014-09-02
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00892-1
  • Notes / Alerts
    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.
  • Extra notes in the data
  • Reason
    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.
  • Action
    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
  • Model / 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