HUGO¿ RAS SYSTEM
Received Jul 15, 2026 · Event occurred Jun 30, 2026
Report 1219930-2026-04464 · MDR key 25824272
Device
Product problems
- Communication or Transmission Problem
- Insufficient Device Problem Information
Patient
75 YR · Male
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT, AT THE START OF THE ROBOT-ASSISTED RADICAL PROSTATECTOMY (RARP) PROCEDURE, THE BIPOLAR FENESTRATED GRASPER (BFG) HAD A PROBLEM WITH MOVEMENT AND WORKING. THE BFG WAS REPLACED WITH NEW BFG. 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.