Events

Recall of Rosa One 3.1(Surgical robot for spine and brain surgeries)

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-2016-RN-01658-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2017-06-09
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01658-1
  • 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
    Two software issues have been identified with the rosa one 3.1.1. specific to spinal surgery application - a product complaint was received by the manufacturer that indicated a risk for robot collision. when driving the robot arm in a surgical procedure, the robot arm comes too close to the robot stand, which leads to the possiblity of colliding with the stand. this issue was further observed during multiple attempts to enable the function "clear the arm (cooperative mode)". the rosanna spine software (version 3.1.0.1225) was identified as non-conforming to the release design.2. specific to brain surgery application - part of the rosa one 3.1 mario software (robot arm software) related to safety in the "cooperative mode" is currently deactivated. the risk of unwanted robot motion with an instrument into the anatomy is mitigated by this software measure.To date, their have been no injuries reported due to these issues.
  • Action
    Software corrections for the Rosa One 3.1 will be performed on site. The Rosanna Spine software correction has occured. Until the Mario software for the brain application is modifed, usage of the device is to be limited to the spine application only. This action has been closed-out on 09/06/2017.

Device

Rosa One 3.1(Surgical robot for spine and brain surgeries)
  • Model / Serial
    Rosa One 3.1(Surgical robot for spine and brain surgeries)Item Number: ROSA00208Serial Number: BS16001ARTG Number: 278903
  • Manufacturer
    Surgicom Pty Ltd

Manufacturer

Surgicom Pty Ltd
  • Source
    DHTGA