Based on the complaint details (b)(4).The patient experienced a rectal perforation requiring a surgery.This event did not occur within the united states.This event occurred at (b)(6) in austria.The event occurred on (b)(6) 2022, and asensus surgical was made aware on 06-september-2022.According to the investigation, further responses from surgeon interviews indicated that the rectal perforation that occurred was not related to the senhance surgical system, but rather considered to be a normal surgical complication unrelated to the robot.Furthermore, no malfunction of the senhance system was reported and no failures were identified.The risk posed by this event was evaluated through a health hazard evaluation (hhe-001-00030) and a corrective action preventative action plan (capa-000048) has been opened to manage the unsuitable timeliness of the receipt and management of this reported event.Therefore, asensus surgical is reporting this followup for completeness to the initial mdr report submitted on 19-september-2023.
|