HUGO¿ RAS SYSTEM
Received Jul 8, 2026 · Event occurred Jun 23, 2026
Report 1219930-2026-04330 · MDR key 25745951
Device
Product problems
- Application Program Freezes or Fails to Launch
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, PRIOR TO A ROBOTIC LAPAROSCOPIC SIGMOIDECTOMY PROCEDURE, AFTER DRAPING AND WHILE INSERTING THE STERILE INTERFACE MODULE (SIM), THE ARM DISPLAYED A NON-RECOVERABLE ERROR. THE SIM WAS REPLACED, AND THE ARM WAS REBOOTED. THE ARM IS WORKING PROPERLY WITHOUT FURTHER ERRORS. THERE WAS NO PATIENT INVOLVEMENT.