MAUDE Adverse Event Report: MONARCH ENDOSCOPY PLATFORM (MONARCH PLATFORM); BRONCHOSCOPE (FLEXIBLE OR RIGID) AND ACCESSORIES

Model 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	05/11/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned for evaluation.There was no allegation of device failure.The risk of pneumothorax is documented in 105-000198-01, rev e, monarch bronch risk management report.Based on the information available for this event, the root cause is related to a known inherent risk of the device and procedure as documented in the device labeling.
Event or Problem Description
It was reported that after a monarch-assisted bronchoscopy procedure the patient experienced a pneumothorax.The target and pneumothorax location were in the right middle lobe (rml).A chest tube was placed in the patient and the patient was hospitalized.The patient was discharged two days after being hospitalized.

• Brand Name: MONARCH ENDOSCOPY PLATFORM (MONARCH PLATFORM)
• Common Device Name: BRONCHOSCOPE (FLEXIBLE OR RIGID) AND ACCESSORIES
• MDR Report Key: 11873893
• Report Number: 3014447948-2021-00014
• Device Sequence Number: 3202645
• Product Code: EOQ
• UDI-Device Identifier: B634MON000005R0
• UDI-Public: +B634MON000005R0/16D20200505
• Combination Product (Y/N): N
• Initial Reporter State: VT
• Initial Reporter Country: US
• PMA/510(K) Number: K173760
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/11/2021

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 Model Number: MON-000005
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/11/2021
• Initial Report FDA Received Date: 05/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention