MAUDE Adverse Event Report: AURIS HEALTH, INC. MONARCH BRONCHOSCOPE; BRONCHOSCOPE (FLEXIBLE OR RIGID) AND ACCESSORIES

Model Number	MBR-000014
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	08/02/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Customer has indicated that the product will not be returned to auris health, inc.As the product has been discarded.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that during a monarch bronchoscopy a patient was bleeding in the right middle lobe following the use of a medtronic arcpoint needle and the monarch forceps.The bleeding obstructed the physician¿s view and was noted in the endotracheal tube.The monarch portion of the case was aborted, and the physician performed an emergent conversion to remove the robot and attempted to control the bleeding.The patient was given a blood transfusion and transported to the operating room (or).When in the or, the physician, while under bronchoscopic guidance, was able to control the bleeding via bronchoscope visualization and epinephrine.Patient was discharged two days later and is doing well.No faults or malfunctions were reported from system.The monarch forceps were discarded during the event and will not be returned for failure analysis.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b1, g3, g6, h2, h6, h10, h11 the customer reported that there were no faults or malfunctions from the robot.Failure analysis was unable to confirm the occurrence of any faults or errors related to the reported issue.Source: s3: 2022-08-02/system120113/{3a9ce66c-2b4c-4a1b-96ff-9183f0b12ffc}.A review of the case video did confirm the reported event where the customer made a pass with the monarch forceps and the patient began to bleed.The product development manager (pdm) reported that the monarch forceps were discarded and would not be available for failure analysis investigation.A device history review was performed for system120113 and there were no non-conformances related to the reported incident in this case.Adding b1: product problem as case was aborted.

• Brand Name: MONARCH BRONCHOSCOPE
• Common Device Name: BRONCHOSCOPE (FLEXIBLE OR RIGID) AND ACCESSORIES
• Manufacturer (Section D): AURIS HEALTH, INC.; 150 shoreline dr.; redwood city CA 94065
• Manufacturer (Section G): AURIS HEALTH, INC.; 150 shoreline dr.; redwood city 94065
• Manufacturer Contact: harminder kaur ; 150 shoreline dr.; redwood city, CA 94065 ; 5106057113
• MDR Report Key: 15336094
• Report Number: 3014447948-2022-00026
• Device Sequence Number: 6927396
• Product Code: EOQ
• UDI-Device Identifier: B634MBR0000141
• UDI-Public: +B634MBR0000141/$0005193481/14D20231113B
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K193534
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/13/2023
• Device Model Number: MBR-000014
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/02/2022
• Supplement Date Received by Manufacturer: 09/22/2022
• Initial Report FDA Received Date: 09/01/2022
• Supplement Report FDA Received Date: 09/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/13/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown