Events

Recall of ROSA Brain and ROSA One Surgical Robots

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-00699-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2017-05-26
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00699-1
  • 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
    Medtech has identified a potential software issue for certain rosa brain and rosa one devices than can prevent it reaching a planned trajectory. when the robot arm is automatically sent onto a trajectory, cartesian coordinates are converted to joint configuration through a mathematical model, and for a very limited number of positions, the mathematical model is imperfect and may prevent the robot arm from reaching the desired position.For automatic moves, if the robot is sent to an unreachable trajectory, the device will display an error message and shut down. a delay of surgery can occur.For “isocentric micromoves” mode used during brain surgery, a hazardous situation can occur if an automatic micro movement to trajectory is planned and an instrument is inside the patient anatomy. if not detected by the user, this could lead to ineffective treatment, serious injury, or even death of the patient.To date medtech has not recorded any complaints for this issue.
  • Action
    Surgicom is currently working on a software correction for this issue, which is expected to be available in July 2017. Surgicom will contact users to arrange for installation of the software update. In the interim, users are to discontinue use of the micromovement function in isocentric mode during brain surgery. In addition, if the issue occurs for other automatic moves, when the error message "A difference in the expected and the actual robot position has been detected. The device will shut down" is displayed users are advised to follow the directions regarding restart and continuation of use of the device that are included in the customer letter.

Device

ROSA Brain and ROSA One Surgical Robots
  • Model / Serial
    ROSA Brain and ROSA One Surgical RobotsROSA Brain 3.0.0 Robotic Surgical AssistantSerial Number: BR15002ROSA One 3.1.0 Robotic Surgical AssistantSerial Number: BS16001ARTG Number: 235379 and 278903
  • Manufacturer
    Surgicom Pty Ltd

Manufacturer

Surgicom Pty Ltd
  • Source
    DHTGA