Hugo¿ RAS System

Description of Event or Problem

It was reported that, during use in a radical cystectomy procedure, an Arm Cart Assembly (ACA, SN - (b)(6)) experienced a critical high-priority non-recoverable error after a collision with another ACA (SN - (b)(6)). There were no issues reported with the other ACA (SN - (b)(6)). After restart, the arm did not initially calibrate, and the entire HUGO system froze for 20 seconds when trying to display the calibration message. The procedure continued temporarily with three arms. The system was later restarted during a procedural break, which did not result in any extended delay of the procedure; after which calibration was completed, and use of the arm resumed for the rest of the procedure. There was no injury to the patient.

Additional Manufacturer Narrative

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.