HUGO¿ RAS SYSTEM
Received Jul 6, 2026 · Event occurred Jun 22, 2026
Report 1219930-2026-04285 · MDR key 25727438
Device
Product problems
- Device Alarm System
- Display or Visual Feedback Problem
Patient
50 YR · Male
- 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. 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 DURING A ROBOTIC LAPAROSCOPIC RETROPUBIC RADICAL PROSTATECTOMY WITH BILATERAL PELVIC LYMPHADENECTOMY, AT THE START OF THE CASE, THE ARM CART ASSEMBLY (ACA) WITH THE ENDOSCOPE TRIGGERED A HIGH-PRIORITY ALARM WITH NO ERROR MESSAGE. THE ISSUE WAS RESOLVED AFTER THE ALARM WAS DISMISSED. THERE WAS NO PATIENT INJURY.