medtronic, FA1253, Hugo Robotically Assisted Surgery RAS System

This field action is being issued following receipt of 13 reports of customers stating that there was a communication interruption between the Hugo RAS System Tower and the Hugo RAS Arm Cart Assembly. These communication interruptions can happen multiple times during a procedure. In two of the complaints received the communication interruptions occurred twice. Each communication interruption led to a non-recoverable error1 on the affected Hugo RAS Arm Cart Assembly.
Once a non-recoverable error occurs, control of the Hugo RAS Arm Cart Assembly is interrupted and the robotic arm and instrument on the Hugo RAS Arm Cart Assembly can no longer be controlled by the surgeon at the surgeon console. Our investigation of this issue identified that the root cause is related to a circuit board component in the Hugo RAS Arm Cart Assembly.
This field action affects only the part number listed above and the serial numbers listed in Attachment #1 of this letter.
No patient harm has occurred with the 13 customer reports. The frequency of occurrence for this issue is improbable and corresponds to an annual rate of 4.5%. Based on our internal review, including the rate of occurrence for the reports and no reports of patient injury, Medtronic is advising that continued use of Hugo RAS Arm Cart Assembly is appropriate when the actions listed below are taken into consideration, unless this continued use is inconsistent with your facility’s internal policies and procedures.