HUGO¿ RAS SYSTEM
Received Jul 6, 2026 · Event occurred Jun 18, 2026
Report 1219930-2026-04282 · MDR key 25727379
Device
Product problems
- Failure to Sense
- Difficult or Delayed Activation
Patient
NA · 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 RADICAL PROSTATECTOMY, WHILE RESECTING THE AREA SURROUNDING THE PROSTATE, THE CLAMPING FORCE OF THE BIPOLAR MARYLAND FORCEPS (BMF) HAD WEAKENED DRASTICALLY. THE MOVEMENT OF THE BMF WAS ON THE VERGE OF FALLING OUT OF SYNCHRONIZATION WITH THE MOVEMENT OF THE HAND CONTROLLER ON THE SURGEON CONSOLE. THE ISSUE WAS RESOLVED BY REPLACING THE BMF. THERE WAS A DELAY OF APPROXIMATELY 25 MINUTES. THERE WAS NO PATIENT INJURY.