HUGO¿ RAS SYSTEM

Description of Event or Problem

IT WAS REPORTED THAT PRE-OPERATIVELY, DURING SYSTEM STARTUP AND PREPARATION, THE TOWER DISPLAYED A NON-RECOVERABLE ERROR WHEN APPLYING STERILE DRAPES. THE SYSTEM WAS SHUT DOWN AND RESTARTED MULTIPLE TIMES; HOWEVER, THE STARTUP COUNTDOWN REPEATEDLY REACHED ZERO, AND THE SYSTEM COULD NOT BE POWERED ON OR OPERATED. NO PATIENT INJURY.

Additional Manufacturer Narrative

PRELIMINARY DEVICE EVALUATION: MEDTRONIC IS LEADING AN EVALUATION OF THE REPORTED TOWER 240V. REVIEW OF THE FIELD SERVICE NOTES INDICATES THAT PRELIMINARY REVIEW OF THE LOGS NOTED AN ERROR CODE ¿COMMUNICATION LOSS: MSC ERROR HANDLER ¿ TOWER¿. THE TOWER POWER SUPPLY CONTROLLER (TPSC) NODE REMAINED UNDEFINED DURING SUBSEQUENT STARTUPS. FIELD SERVICE REPLACED THE COMPONENTS CONSISTENT WITH A TOWER COMMUNICATION-PATH AND FOLLOWING REPLACEMENT OF THESE COMPONENTS, THE SYSTEM OPERATED AS INTENDED AND THE SYSTEM PERFORMANCE CHECK PASSED. FURTHER EVALUATION OF THE REPORTED TOWER 240V 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.