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

Catalog Number	MON-000005
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pneumothorax (2012)
Date of Event	09/23/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned for evaluation.There was no allegation of device failure.It was the physician's belief that the pneumothorax occurred during the biopsy with either of the two non-auris instruments used which was not confirmed.The risk of pneumothorax is documented in 105-000198-01, rev e, monarch bronch risk management report.Based on the information available for this complaint, the root cause of the reported event is related to a known inherent risk of the device and procedure as documented in the device labeling.
Event or Problem Description
On 9/23/2019, it was reported that during a monarch-assisted biopsy procedure, the patient experienced a pneumothorax.The pneumothorax was noted to be in the same area as the target lesion.The customer confirmed that the customer received a chest tube and shortly recovered and was released.Based on the information provided by the physician, there was no device failure.It was the customer's belief that the pneumothorax could be attributed to the biopsy that was performed with non-auris instruments.

• Brand Name: MONARCH ENDOSCOPY PLATFORM (MONARCH PLATFORM)
• Common Device Name: BRONCHOSCOPE (FLEXIBLE OR RIGID) AND ACCESSORIES, PRODUCT CODE: EOQ
• Manufacturer (Section D): AURIS HEALTH, INC.; 150 shoreline drive; redwood city CA 94065
• MDR Report Key: 9203529
• Report Number: 3014447948-2019-00015
• Device Sequence Number: 3058142
• Product Code: EOQ
• UDI-Device Identifier: B634MON0000050
• UDI-Public: +B634MON0000050/16D20181106
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K173760
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 09/23/2019

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: No Information
• Device Catalogue Number: MON-000005
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/23/2019
• Initial Report FDA Received Date: 10/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1