Hugo¿ RAS System

Description of Event or Problem

It was reported that during a robotic laparoscopic prostatectomy procedure, while the surgeon was operating on the seminal vesicle, the Surgeon Console (SC) lost communication, followed by an unrecoverable console error. The team powered off the SC, powered it on again, and recalibrated it, after which it functioned without further issue. There was a five-minute delay. There was no patient injury.

Additional Manufacturer Narrative

Preliminary Device Evaluation: Medtronic is leading an evaluation of the reported Surgeon Console (SC). Review of the field service notes states that functional checks were carried out by simulating a procedure for several hours without detecting any malfunction. Functional tests were performed. All tests were passed. Review of the two provided images notes that they both show the Operating room team interface (ORTI) displaying the following error messages: 1. "WARNING: Unrecoverable surgeon console error. Restart the surgeon console. If the error occurs again, continue using bedside control or discontinue use of the system. 3 h, 12 min, 06 s" 2. "CAUTION: Communication with the surgeon console has been lost. Check the console data cable. If the error persists, restart the surgeon console. 3 h, 12 min, 06 s" Further evaluation of the reported Surgeon Console is still pending, and the investigation is not able to identify a root cause at this time. Additional information will be provided in the final vigilance 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.