HUGO¿ RAS SYSTEM

Description of Event or Problem

IT WAS REPORTED THAT DURING A ROBOTIC LAPAROSCOPIC LOWER ANTERIOR RECTUM PROCEDURE, THE ARM CART ASSEMBLY (ACA) WAS NOT DETECTED ON THE TOWER SYSTEM. A LOANER ARM WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

Additional Manufacturer Narrative

PRELIMINARY DEVICE EVALUATION: MEDTRONIC IS LEADING AN EVALUATION OF THE REPORTED ARM CART ASSEMBLY (ACA). REVIEW OF THE FIELD SERVICE NOTES INDICATES THAT THE INSTRUMENT DRIVE UNIT (IDU) OF THE ACA WAS REPLACED TO RESOLVE THE ISSUE. FURTHER EVALUATION OF THE REPORTED ARM CART ASSEMBLY IS STILL PENDING, AND THE INVESTIGATION IS NOT ABLE TO IDENTIFY A ROOT CAUSE AT THIS TIME. ADDITIONAL INFORMATION WILL BE PROVIDED IN A SUPPLEMENTAL REGULATORY REPORT WHEN THE INVESTIGATION IS COMPLETE. 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.