HUGO¿ RAS SYSTEM
Received Jul 8, 2026 · Event occurred Jul 7, 2026
Report 1219930-2026-04340 · MDR key 25753559
Device
Product problems
- Display or Visual Feedback Problem
- Complete Loss of Power
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
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. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.
Description of Event or Problem
IT WAS REPORTED THAT PRE-OPERATIVELY, DURING SYSTEM STARTUP, TWO ARM CART ASSEMBLIES (ACAS) DISPLAYED AN ARM ERROR ALARM AND APPEARED TO HAVE NO ELECTRICAL POWER, AS THE STATUS LED LIGHTS DID NOT TURN ON. ON-SITE TROUBLESHOOTING, INCLUDING CHANGING CONNECTION PORTS, SWAPPING CONNECTION CABLES, AND PERFORMING A FULL SYSTEM RESTART, DID NOT RESOLVE THE ISSUE. NO PATIENT INVOLVEMENT.