Medtronic Issues Urgent Field Safety Notice for Hugo Robotic-Assisted Surgery System Following Power Supply Failures Linked to Six Minor Injuries

Medtronic Issues Urgent Field Safety Notice for the Main Console of Its Soft Tissue Surgical Robot Hugo in Europe

Announcement Content

Specific Batch HugoThe MasterPotential Power Supply Risk in the Console. Medtronic has received 25 complaints regarding power failures in the main console, which caused power outages (this power supply provides electricity for the entire console except for the self-powered 3D monitor).

Power failure may result in the permanent loss of remote system operation capabilities of the main console pre-operatively or intra-operatively. During the failure, the tower and robotic arm cart components will remain operational, supporting manual operation of the robotic arms and/or removal of instruments and endoscopes if necessary.

Among the 25 complaints investigated, Medtronic reported zero cases of serious patient injury. Six complaints reported non-serious injuries: five cases were converted to laparoscopic surgery, and one case required switching to another robotic system (in two cases, the operation duration was extended by more than 30 minutes). The remaining 19 cases reported no injuries.

Medtronic states that potential risks include treatment delays, bleeding, tissue damage and/or trauma, but patients who have undergone Hugo surgery are not affected.

After internal evaluation, Medtronic believes that the Hugo system can continue to be used, and plans to inspect the affected equipment and carry out maintenance in the coming months.

Introduction to Hugo

Hugo is aModular soft tissue surgical robot, which, like the Da Vinci surgical robot, can be applied to various types of surgeries. It also features wristed instruments, 3D visualization, and Touch Surgery Enterprise.A cloud-based surgical video capture and management solution,Powered by artificial intelligence, enabling surgeons to seamlessly record, analyze, and share Hugo case footage.), as well as a dedicated support team specializing in robotic procedure optimization, services, and training.

Hugo received CE approval for marketing in 2021;

The first surgery was completed in Europe in 2022;

The first IDE study (Expand-URO) in the United States was enrolled in 2022;

Clinical research in the United States in 2024The research has expanded to the fields of hernia and benign gynecology, and clinical enrollment has been completed;

Medtronic Announcement in April 2025Expand-URO Clinical Research Data:

• Safety:The incidence of Grade 3 or higher complications was significantly lower than the preset target.

• Effectiveness: The success rate of the surgery was 98.5%, far exceeding the preset goal of 85%.

April 2025Medtronic Submits to FDARegistration Application (Urology Indications）；

Expanded to the United States for clinical research in 2025TumorGynecologySurgery.