Events

Safety Alert for ROSA Brain 3.0.0 Robotic Surgical Assistant

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Medtech SA.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Date
    2017-03-28
  • Event Date Posted
    2017-03-28
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20170328.html
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Medical device safety alert: rosa brain 3.0.0 robotic surgical assistant the therapeutic goods administration (tga) of australia has posted a medical device safety alert concerning rosa brain 3.0.0 robotic surgical assistant [serial number: br15002], manufactured by medtech sa. according to the manufacturer, 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. for details, please refer to the tga website: http://apps.Tga.Gov.Au/prod/sara/arn-detail.Aspx?k=rc-2017-rn-00404-1 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 28 march 2017.

Device

ROSA Brain 3.0.0 Robotic Surgical Assistant
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: ROSA Brain 3.0.0 Robotic Surgical Assistant
  • Manufacturer
    Medtech SA

Manufacturer

Medtech SA
  • Manufacturer Parent Company (2017)
    Zimmer Biomet Holdings
  • Manufacturer comment
    “The safety of patients has always been, and continues to be, Zimmer Biomet’s top priority and it is our honor to be a leader in this industry for the past 90 years,” Zimmer Biomet told ICIJ in a statement. “We adhere to strict regulatory standards, and work closely with the FDA and all applicable regulatory agencies in each of our regions as part of our commitment to operating a first-rate quality management system across our global manufacturing network. The company added that it is focused on staying at the forefront of innovation and doing right by the millions of patients who rely on the company’s products.
  • Source
    DH