HUGO¿ RAS SYSTEM
Received Jul 1, 2026 · Event occurred Jun 16, 2026
Report 1219930-2026-04234 · MDR key 25683162
Device
Product problems
- 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 VAGINAL HYSTERECTOMY PROCEDURE, BIPOLAR OUTPUT WAS PRESENT ON THE BIPOLAR FENESTRATED GRASPER (BFG), BUT NO CLINICAL EFFECT WAS OBSERVED. THE TEAM CHECKED THE CONNECTION OF THE CORD ON BOTH THE BFG AND GENERATOR SIDES, AND NO ABNORMALITIES WERE FOUND. EVEN WHEN BIPOLAR ENERGY WAS APPLIED WITH THE JAWS FULLY CLOSED, NO CLINICAL EFFECT WAS OBSERVED. THE INSTRUMENT WAS THEN REPLACED WITH A NEW BFG TO RESOLVE THE ISSUE. AFTER REPLACEMENT, IT WAS CONFIRMED THAT BIPOLAR OUTPUT PRODUCED THE EXPECTED CLINICAL EFFECT ON THE SAME TISSUE. THERE WAS NO PATIENT INJURY.