FDA Adverse Event
Injury
Summary report: N
MONARCH ENDOSCOPY PLATFORM (MONARCH PLATFORM)
MDR report key: 22804836
·
Received August 14, 2025
Report
- Report Number
- 3014447948-2025-00024
- Event Type
- Injury
- Date Received
- August 14, 2025
- Report Date
- August 14, 2025
- Manufacturer
- AURIS HEALTH, INC.
- Product Code
- EOQ
- UDI-DI
- B634MON00000501R0
- PMA / PMN Number
- K211493
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
THE FOLLOWING ARTICLE HAS BEEN REVIEWED: MCNIERNEY D, CHEN J, ZEIN JG, VASZAR L, SWANSON K, AZADEH N, SAKATA KK. COMPARING MONARCH VERSUS ION ROBOTIC-ASSISTED BRONCHOSCOPY PLATFORMS: A PROPENSITY SCORE-MATCHED ANALYSIS. J BRONCHOLOGY INTERV PULMONOL. 2025 JUL 15;32(4):E01019. DOI: 10.1097/LBR.0000000000001019. PMID: 40662912, AND CITED FOUR (4) INSTANCES OF PNEUMOTHORAX WITH CHEST TUBE PLACEMENT. THIS REPORT IS BEING SUBMITTED FOR THESE EVENTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 865833 | MONARCH ENDOSCOPY PLATFORM (MONARCH PLATFORM) | BRONCHOSCOPE (FLEXIBLE OR RIGID) AND ACCESSORIES | EOQ | AURIS HEALTH, INC. | B634MON00000501R0 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention |