HUGO¿ RAS SYSTEM
Received Jul 10, 2026
Report 1219930-2026-04399 · MDR key 25786114
Device
Product problems
- Unintended Collision
- Communication or Transmission Problem
- Positioning Problem
- No Apparent Adverse Event
- No Tactile Prompts/Feedback
Patient
NA · Unknown
- Insufficient Information
Narrative
Additional Manufacturer Narrative
MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.
Description of Event or Problem
IT WAS REPORTED THAT CONCERNS WERE RAISED REGARDING PRACTICAL CHALLENGES WITH THE HUGO PLATFORM, PARTICULARLY RELATED TO BEDSIDE ASSISTANT POSITIONING AND ARM MOVEMENT. IT WAS FURTHER REPORTED THAT ASSISTANT-RELATED ISSUES HAD OCCURRED, INCLUDING REPORTED INJURIES TO THE BEDSIDE ASSISTANT ASSOCIATED WITH ARM MOVEMENT. ADDITIONAL CONCERNS WERE RAISED REGARDING ERGONOMICS, ROOM SETUP, AND ACCESS OR PORT PLACEMENT IN RELATION TO THE MODULAR DESIGN. NO PATIENT INFORMATION WAS PROVIDED.