Events

Recall of da Vinci X Patient Side Cart Arm Controller Joint Circuit Boards

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-2018-RN-00231-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2018-03-13
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00231-1
  • 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
    Intuitive surgical has become aware that circuit boards in specific da vinci x surgical system arms are susceptible to early failures that may result in system faults. the affected arms include arm controller joint circuit boards manufactured with components from a specific manufacturing lot that, due to manufacturing variations, may fail prematurely.As indicated in the user manual, if an arm-specific fault occurs on a system during a procedure and the fault cannot be recovered, the affected arm can be disabled and the procedure may be continued with three arms.If a fault that is not arm-specific occurs, restarting the system may clear the fault. however, the fault may recur. the user may then decide to abort the da vinci procedure or convert to an alternate surgical method.There have been no patient injuries as a result of this issue.
  • Action
    Device Technologies will be replacing the affected Arm Controller Joint Circuit Boards as a permanent correction.

Device

da Vinci X Patient Side Cart Arm Controller Joint Circuit Boards
  • Model / Serial
    da Vinci X Patient Side Cart Arm Controller Joint Circuit BoardsModel Number: IINS-IS4200Serial Number: SL0015ARTG Number: 97348(Device Technologies Australia - Robot, surgical, operation unit)
  • Manufacturer
    Device Technologies Australia Pty Ltd

Manufacturer

Device Technologies Australia Pty Ltd