HUGO¿ RAS SYSTEM

Additional Manufacturer Narrative

DEVICE EVALUATION: MEDTRONIC IS LEADING AN EVALUATION OF THE REPORTED MONOPOLAR CURVED SHEARS (MCS). EVALUATION OF THE FIRST PROVIDED IMAGE SHOWS THE ERROR MESSAGES: "ARM 3: (CAUTION) STERILE INTERFACE MODULE NOT CONNECTED OR NON-FUNCTIONAL. ARM STERILE BARRIER MAY BE OPEN.", "ARM 3: INSERTION DISABLED. IF DOCKED, ATTACH SUPPORTED INSTRUMENT. IF DRAPING/UN-DOCKED, OPEN PORT LATCH TO MOVE INSTRUMENT DRIVE UNIT." AND "ARM 3: DETACH MONOPOLAR CURVED SHEARS AND INSPECT TIP COVER. INSTALL A NEW TIP COVER IF NEEDED. REATTACH TO CONTINUE INSTRUMENT USE." THE SECOND IMAGE SHOWS THE MCS WHICH SEEMED TO HAVE NO ISSUES. THE THIRD IMAGE SHOWS THE TOP VIEW OF THE ADAPTER OF THE MCS. THE FOURTH IMAGE SHOWS THE PRODUCT ID MRASI0001 AND SERIAL NUMBER (B)(6) WHICH MATCHES THE PRODUCT ID AND SERIAL NUMBER REPORTED. FURTHER EVALUATION OF THE REPORTED MONOPOLAR CURVED SHEARS 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.

Description of Event or Problem

IT WAS REPORTED THAT AT THE BEGINNING OF AN INGUINAL HERNIA REPAIR, BEFORE MAKING THE FIRST INCISION TO OPEN TO PERITONEAL FLAP AND DISSECT THE INGUINAL SPACE, THE MONOPOLAR CURVED SHEARS (MCS) STOPPED BEING RECOGNIZED. THE INSTRUMENT NAME WAS REPLACED WITH "INSTRUMENT NOT ATTACHED" AND THE SURGEON WAS UNABLE TO CONTROL IT. THE ISSUE COULD NOT BE RESOLVED AFTER DETACHING AND REATTACHING THE MCS, AND REPLACING THE STERILE INTERFACE MODULE (SIM) ONLY RESOLVED THE ISSUE FOR APPROXIMATELY 3 SECONDS BEFORE THE "INSTRUMENT NOT ATTACHED" MESSAGE APPEARED AGAIN. THE ISSUE WAS RESOLVED AFTER REPLACING THE MCS. THERE WAS NO PATIENT INJURY.