Events

Recall of ROSA Brain 3.0.0 Robotic Surgical Assistant

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Surgicom 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-2017-RN-00404-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2017-03-24
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00404-1
  • 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
    Investigation revealed that a computer file parameter that is linked to the robot arm calibration has been modified by the robot arm supplier without notification to the manufacturer. as a result, once the robot arm is on a trajectory, if the system reboots or shuts down (voluntarily or due to an error) without the robot arm returning to a parking position, the device’s applicative accuracy may decrease to a level below the applicable specification. in the event that the inaccurate tool positioning of the instruments by the rosa devices is not detected by the user, it could ultimately lead to ineffective treatment, serious injury or death of the patient. to date, no complaint reports, which could be linked to the above issue in normal conditions of use, have been recorded.
  • Action
    As an interim measure, Surgicom is requesting users to follow the instructions as detailed in the recall notification letter. This action has been closed-out on 15/03/2018.

Device

ROSA Brain 3.0.0 Robotic Surgical Assistant
  • Model / Serial
    ROSA Brain 3.0.0 Robotic Surgical AssistantSerial Number: BR15002ARTG Number: 235379
  • Manufacturer
    Surgicom Pty Ltd

Manufacturer

Surgicom Pty Ltd
  • Source
    DHTGA