Indications, Safety, and Warnings

The Hugo™ Robotically Assisted Surgery (RAS) System is intended to assist in the accurate control of instruments and accessories including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, forceps/graspers, needle holders, electrosurgical tools and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrosurgery, and suturing during minimally invasive urologic surgical procedures. The system is indicated for adult use. It is intended to be used by trained physicians in an operating room environment in accordance with the representative surgical procedures set forth in the Hugo™ RAS System Indications Document.

The potential adverse events associated with the use of robotically assisted surgical devices include, but are not limited to: arrhythmia, bleeding, blunt trauma, bowel perforation, burns (varying degrees, bowel, thermal), crushing injury, delay of treatment (prolonged procedure), electric shock, foreign body in patient, infection, inflammation, tissue damage/trauma, toxicity, or vessel perforation.

There are no device specific contraindications for the Hugo™ RAS system.

The demonstration of safety and effectiveness for the specific procedures discussed in the labeling was based on evaluation of the device as a surgical tool that assists in the accurate control of robotically-controlled instruments to perform coordinated surgical tasks. The evaluation did not include assessment of outcomes related to the treatment of cancer (e.g., overall survival, disease-free survival, local recurrence) or any specific treatment of any underlying disease or condition.

Refer to Hugo™ RAS System user’s guide, indications document and other supplemental labeling for detailed information regarding the procedures, indications, contraindications, warnings, precautions, and potential complications/adverse events. Contact Medtronic at rs.globalroboticsservicesupport@medtronic.com to request the latest version or visit Medtronic.com/manuals.

US-RP-2500175: 2025-12