HUGO¿ RAS SYSTEM

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 AN INITIAL REVIEW OF THE LOGS NOTED AN ERROR CODE ¿ARM [ARM#] NON-RECOVERABLE ERROR_RA J5 (JOINT_5 OF ROBOTIC ARM) POSITION FAILURE¿. RESTARTING THE ACA RESOLVED THE ISSUE. EVALUATION OF THE DEVICE DATA INDICATES THE ACA EXPERIENCED AN ERROR CODE ¿ARM FAILURE - NON-RECOVERABLE - RA_J5 (JOINT_5 OF ROBOTIC ARM) REDUNDANCY CHECK¿ WHICH INDICATES THAT THE LOCATION OF THE REFERENCE SWITCH ON THE Z-SLIDE IS MEASURED TO BE IN A DIFFERENT PLACE FROM WHERE IT WAS ORIGINALLY DETECTED DURING CALIBRATION. THE ACCURACY OF THE POSITION CAN BE INFLUENCED BY THE BELT TENSION AND THE AIR GAP BETWEEN THE REFERENCE SENSOR AND THE INSTRUMENT DRIVE UNIT (IDU) CARRIAGE PLATE. THE ERROR CODE DISPLAYS THE FOLLOWING ERROR MESSAGE TO THE USER: ¿WARNING: ARM ERROR. WITHDRAW INSTRUMENT, UNPLUG AND RECONNECT ARM. IF ERROR REOCCURS, REMOVE ARM FROM USE; CONTACT MEDTRONIC SUPPORT¿ AND IS A SYSTEM RECOVERABLE INOPERABLE_ERROR AND SUBSYSTEM NON-RECOVERABLE INOPERABLE_ERROR. 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.

Description of Event or Problem

IT WAS REPORTED THAT DURING A ROBOTIC LAPAROSCOPIC RADICAL PROSTATECTOMY PROCEDURE, THE ARM CART ASSEMBLY (ACA) HAD ARM ERRORS AND IT WAS NOT POSSIBLE TO USE THE ARM IN TELEOPERATION. THE ARM WAS RESTARTED AND WORKED NORMALLY FOR THE REST OF THE PROCEDURE. THERE WAS NO PATIENT INJURY.