HUGO¿ RAS SYSTEM

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 CHOLECYSTECTOMY, WHILE DISSECTING THE CYSTIC DUCT, IMAGE QUALITY SIGNIFICANTLY DECREASED AFTER INDOCYANINE GREEN (ICG) MODE WAS ACTIVATED ON THE SURGEON CONSOLE (SC) TO VISUALIZE THE CYSTIC ARTERY. A SLIGHT VIDEO DELAY WAS ALSO NOTED. THE ISSUE WAS RESOLVED BY SWITCHING BACK TO STANDARD IMAGING MODE. AFTER RETURNING TO STANDARD IMAGING MODE, THE SURGEON STATED THAT THE DIFFERENCE WAS VERY NOTICEABLE AND EXPRESSED DISSATISFACTION WITH THE ICG IMAGE QUALITY AND PERFORMANCE. THERE WAS NO PATIENT INJURY.