HUGO¿ RAS SYSTEM
Received Jul 6, 2026 · Event occurred Jul 3, 2026
Report 1219930-2026-04276 · MDR key 25725289
Device
Product problems
- Difficult to Remove
- Communication or Transmission Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT DURING A ROBOTIC-ASSISTED PROSTATECTOMY LAPAROSCOPIC PROCEDURE, DURING LYMPHADENECTOMY AND VESSEL DISSECTION, T HE MONOPOLAR CURVED SHEARS (MCS) GENERATED A HIGH-PRIORITY ALARM RESULTING IN LOSS OF TELEOPERATION AND BEDSIDE CONTROL. THE INSTRUMENT WAS REMOVED USING THE BROKEN INSTRUMENT TECHNIQUE AND THEN REINSERTED, AFTER WHICH FUNCTION WAS RESTORED. THERE WAS NO INJURY TO THE PATIENT.
Additional Manufacturer Narrative
CONTINUE FROM D10: PRODUCT ID: MRASC0002 SN: (B)(6). PRODUCT ID: MRASC0002 SN: (B)(6). PRODUCT ID: MRASC0002 SN: (B)(6). PRODUCT ID: MRASC0001 SN: UNKNOWN. 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.