HUGO¿ RAS SYSTEM
Received Jul 8, 2026 · Event occurred May 18, 2026
Report 1219930-2026-04332 · MDR key 25748744
Device
Product problems
- Difficult or Delayed Activation
Patient
Male
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT DURING THE PROCEDURE, THE BIPOLAR CORD WAS DETACHED (EASILY CAME OFF) FROM THE BIPOLAR FENESTRATED GRASPER AND THERE WERE TWO INSTANCES WHERE IT COULD NOT OUTPUT. THE LOOSE CORD WAS REINSERTED AND THE PROCEDURE WAS COMPLETED. A NEW BIPOLAR CORD WAS NOT USED. THE COMPLAINT WAS UNRELATED TO THE GENERATOR. 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.