Adverse-event reports (MAUDE)
Read this first: MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line shows reporting volume for the average device in the same FDA product code — a reporting baseline, not a risk measure.
11 linked reportsMalfunction 8Injury 3
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2022-09 | 2 | 2.5 |
| 2023-03 | 2 | 2.5 |
| 2024-01 | 2 | 2.5 |
| 2024-10 | 1 | 1 |
| 2026-01 | 2 | 2 |
| 2026-03 | 2 | 2 |
Failure-mode summaryAI-generated
11 linked report narratives available — no AI summary generated yet.
Recall history
| Initiated | Recall # | Class | Status | Reason | Quantity | Link basis |
|---|---|---|---|---|---|---|
| 2025-10-18 | Z-0543-2026 | Class II | Open, Classified | Potential that product was leak tested with equipment outside of its expected operating range, resulting in bronchoscopes that may not be susceptible to leaks.Distribution: Nationwide distribution to AL, AZ, CA, CO, CT, DC, FL, GA, ID, IL, IN, KY, MA, MI, MS, MT, NC, NE, NJ, NM, NY, OH, OR, PA, SC, SD, TN, VA, VT, WA, WV. | 1,477 units | clearance family |
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2026-03-25 | 24686535 | Malfunction | Available | catalog number |
| 2026-01-14 | 24066689 | Malfunction | Available | catalog number |
| 2024-10-01 | 3014447948-2024-00021 | Malfunction | Available | model number |
| 2024-01-29 | 3014447948-2023-00035 | Injury | Available | model number |
| 2024-01-26 | MW5150830 | Malfunction | Available | model number |
| 2023-03-08 | 3014447948-2023-00010 | Malfunction | Available | catalog number |
| 2022-09-07 | 3014447948-2022-00028 | Injury | Available | catalog number |
Showing the most recent 7 of 11 linked reports.
Regulatory clearances
- 510(k)K231473Substantially equivalent (SESE) · 2023-11-28clearance family
Predicate lineage
Lineage each submission cites, walked transitively (indented = the cited device's own predicates). Extracted from public 510(k) summary text — heuristic, and includes reference devices mentioned alongside true predicates.
Manufacturer compliance record
| Date | Type | Outcome | Facility | Citations |
|---|---|---|---|---|
| 2020-02-07 | NAI | No action indicated | Auris Health Inc. | 0 |
| 2020-02-06 | NAI | No action indicated | AURIS HEALTH INC | 0 |
| 2020-02-06 | NAI | No action indicated | AURIS HEALTH INC | 0 |
| 2017-07-11 | NAI | No action indicated | Auris Health Inc. | 0 |
| 2017-02-13 | NAI | No action indicated | Auris Health Inc. | 0 |
Similar devices
- Monarch Bronchoscope Auris Health, Inc. (same company)
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