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

Model Number	MBR-000211-A
Medical Device Problem Code	No Display/Image (1183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/19/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The clinical specialist reported that during the procedure, the live camera view on the scope suddenly became static and fuzzy, leading to a loss of view.The user switched scopes and successfully navigated to the lesion.However, while biopsying, an fault occurred, indicating disconnection of the scope and disabling of robotic functions.Despite attempts, the user couldn't turn the camera back on or clear the error.The clinical specialist mentioned that the issue recurred with the second scope during biopsying.Consequently, the physician decided to end the procedure without further biopsies.There were no reported adverse effects to the patient because of the scope issues.
Additional Manufacturer Narrative
The subject scope was connected to an in-house system 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, and the camera image to confirm that there was no intermittent open on either sensor or camera image degradation.The results observed both sensors to be within specification, and the camera to be functional with no signs of image degradation.Additionally, the led was not functioning.The scope was connected to the in-house system for thirty minutes and no led was observed.A closer inspection of the scope handle, shaft, cable, and connector observed no external physical damage that could contribute to the reported issue.Note: manufacturer report numbers 3014447948-2024-00004 are for the same patient event.

• 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 ; 6282544750
• MDR Report Key: 18921615
• Report Number: 3014447948-2024-00005
• Device Sequence Number: 7683180
• Product Code: QNW
• UDI-Device Identifier: B634MBR000211A1
• UDI-Public: +B634MBR000211A1/14D20240509C
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• 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
• Report Date (Section B): 03/18/2024

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/09/2024
• Device Model Number: MBR-000211-A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/13/2024
• Initial Report FDA Received Date: 03/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/09/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown