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

Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/11/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported during a monarch bronchoscopy procedure the physician experienced a 1205-50-0-0 fault when pressing the ¿set¿ during roll correction.The physician repositioned the field generator, power cycled the system, and switched to a second scope, however, the issue persisted.The physician chose to abort the procedure and reschedule.There were no reported adverse effects to the patient as a result of the system fault code.
Additional Manufacturer Narrative
The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Additional Manufacturer Narrative
The reported issue occurred on a device used for diagnosis and not treatment.Because the reported issue is associated with scope performance, an examination of the subject scope was performed.A visual examination of the scope handle, shaft, and tip observed no external damage.To verify the scope latched onto the instrument device manipulator (idm), the scope was then connected and disconnected to 2 different idm top plates 10x each.The scope was then connected and disconnected to 2 different benchtop idm fixtures 10x each.The scope was then connected and disconnected onto an in-house system on both idms 10x each.No latching issue was observed.The subject scope was connected to a bench test fixture to verify electrical functionality of the camera, light emitting diode (led), and electromagnetic sensors (em).The scope tip was manually articulated while monitoring the resistance of each sensor to confirm that there was no intermittent open on either sensor.The results showed observed both sensors to be within specification.The scope was left connected to the in-house system for thirty minutes and the image was observed to be stable and clear.A closer inspection of the scope handle, shaft, cable, and connector observed no physical damage that could contribute to the reported issue.The results showed the bronchoscope to be operating as expected.The scope was then connected to an in-house system to confirm the functionality of the scope.The scope was then driven through a lung model and was successfully able to be initialized without receiving a fault id: 1205-50-0-0 nav initialization error.See images below.Although there was no video available for review during the case, a review of the plan id faults confirmed the occurrence of 1205 fault.A review of the calibration data obtained from production final acceptance testing revealed all acceptance criteria were met and no anomalies found.Based on the results from the examination, the product met specifications.A review of similar investigations with similar reported issue (1205 nav initialization) has noted that this is a known issue and have not established a possible root cause.Risk document number: 105-000369-00 rev k dfmea software bronch 2.0.No further action is needed based on the risk acceptance.This issue will be tracked and trended in the monthly complaint trend review meetings.

• Brand Name: MONARCH BRONCHOSCOPE
• Common Device Name: BRONCHOSCOPE (FLEXIBLE OR RIGID) AND ACCESSORIES
• Manufacturer (Section D): AURIS HEALTH, INC.; 150 shoreline drive; redwood city CA 94065
• Manufacturer (Section G): AURIS HEALTH, INC.; 150 shoreline drive; redwood city 94065
• Manufacturer Contact: andria smith ; 150 shoreline drive; redwood city, CA 94065 ; 5745510671
• MDR Report Key: 15807348
• Report Number: 3014447948-2022-00039
• Device Sequence Number: 5747226
• Product Code: QNW
• UDI-Device Identifier: B634MBR000211A1
• UDI-Public: +B634MBR000211A1/14D202302137
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K203614
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/13/2023
• 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: 11/11/2022
• Supplement Date Received by Manufacturer: 12/29/2022
• Initial Report FDA Received Date: 11/16/2022
• Supplement Report FDA Received Date: 01/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/13/2021
• 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
• Patient Sex: Unknown