HUGO¿ RAS SYSTEM
Received Jul 9, 2026 · Event occurred Jun 24, 2026
Report 1219930-2026-04355 · MDR key 25762595
Device
Product problems
- Break
- Difficult to Remove
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT, DURING A ROBOTIC LAPAROSCOPIC ROUX-EN-Y GASTRIC BYPASS PROCEDURE, THE BIPOLAR FENESTRATED GRASPER (BFG) BROKE. THE BFG WAS REMOVED THROUGH BROKEN INSTRUMENT PROTOCOL AND WAS REPLACED WITH A NEW ONE. THE SURGERY PROCEEDED WITH NO FURTHER ISSUES. 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.