HUGO¿ RAS SYSTEM
Received Jul 1, 2026 · Event occurred Jun 15, 2026
Report 1219930-2026-04233 · MDR key 25683073
Device
Generic name
Modular Electromechanical Surgical System
Manufacturer
Covidien SurgicalModel number
MRASI0001Catalog number
MRASI0001
Product problems
- Failure to Cut
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT DURING A ROBOTIC LAPAROSCOPIC PROSTATECTOMY PROCEDURE, TWO MONOPOLAR CURVED SHEARS (MCS) WERE DULL AND DID NOT HAVE GOOD CUTTING PROPERTIES. BOTH INSTRUMENTS WERE REPLACED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
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.