HUGO¿ RAS SYSTEM
Received Jul 3, 2026 · Event occurred Jun 18, 2026
Report 1219930-2026-04257 · MDR key 25702945
Device
Generic name
Modular Electromechanical Surgical System
Manufacturer
Covidien SurgicalModel number
MRASI0001Catalog number
MRASI0001
Product problems
- Break
- Difficult or Delayed Activation
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. 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 HYSTERECTOMY PROCEDURE, THE TIP OF THE MONOPOLAR CURVED SHEARS (MCS) DID NOT CLOSE FULLY. THE INSTRUMENT WAS REPLACED WITH A NEW FORCEPS TO PROCEED WITH THE SURGERY. LATER, DEFORMATION OF THE MCS TIP WAS OBSERVED. THERE WAS NO PATIENT INJURY.