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.
74 linked reportsInjury 59Malfunction 15
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 0 | 3.15 |
| 2019-02 | 0 | 2.5 |
| 2019-03 | 0 | 5.48 |
| 2019-04 | 0 | 16.27 |
| 2019-05 | 0 | 3.61 |
| 2019-06 | 0 | 2.9 |
| 2019-07 | 0 | 2.56 |
| 2019-08 | 0 | 3.75 |
| 2019-09 | 0 | 2.5 |
| 2019-10 | 0 | 2.37 |
| 2019-11 | 0 | 2.18 |
| 2019-12 | 0 | 4.71 |
| 2020-01 | 0 | 2.5 |
| 2020-02 | 0 | 4.32 |
| 2020-03 | 0 | 2.27 |
| 2020-04 | 0 | 4.19 |
| 2020-05 | 0 | 2.58 |
| 2020-06 | 0 | 3.62 |
| 2020-07 | 0 | 3.35 |
| 2020-08 | 0 | 2.91 |
| 2020-09 | 0 | 2.95 |
| 2020-10 | 1 | 3.19 |
| 2020-11 | 0 | 3.67 |
| 2020-12 | 0 | 4.92 |
| 2021-01 | 0 | 3.4 |
| 2021-02 | 1 | 3.04 |
| 2021-03 | 3 | 4.43 |
| 2021-04 | 2 | 3.89 |
| 2021-05 | 1 | 4.53 |
| 2021-06 | 2 | 4.19 |
| 2021-07 | 1 | 3.18 |
| 2021-08 | 2 | 4 |
| 2021-09 | 1 | 3.48 |
| 2021-10 | 0 | 3.84 |
| 2021-11 | 1 | 3.48 |
| 2021-12 | 1 | 4.14 |
| 2022-01 | 2 | 4.11 |
| 2022-02 | 1 | 4 |
| 2022-03 | 1 | 5.42 |
| 2022-04 | 0 | 5.5 |
| 2022-05 | 0 | 5.16 |
| 2022-06 | 1 | 4.75 |
| 2022-07 | 4 | 5.57 |
| 2022-08 | 1 | 4.8 |
| 2022-09 | 4 | 4.56 |
| 2022-10 | 1 | 5 |
| 2022-11 | 3 | 4.97 |
| 2022-12 | 2 | 4.89 |
| 2023-01 | 4 | 6.88 |
| 2023-02 | 1 | 4.82 |
| 2023-03 | 1 | 6.39 |
| 2023-04 | 0 | 5.47 |
| 2023-05 | 0 | 5.6 |
| 2023-06 | 0 | 6.44 |
| 2023-07 | 1 | 5.21 |
| 2023-08 | 3 | 6.32 |
| 2023-09 | 3 | 5.97 |
| 2023-10 | 2 | 6.56 |
| 2023-11 | 2 | 6.24 |
| 2023-12 | 7 | 6.12 |
| 2024-01 | 0 | 5.8 |
| 2024-02 | 1 | 5.32 |
| 2024-03 | 3 | 6.14 |
| 2024-04 | 1 | 5.33 |
| 2024-05 | 0 | 5.3 |
| 2024-06 | 1 | 6.54 |
| 2024-07 | 1 | 5.29 |
| 2024-08 | 1 | 6.8 |
| 2024-09 | 0 | 6.15 |
| 2024-10 | 2 | 6.67 |
| 2024-11 | 0 | 8.77 |
| 2024-12 | 2 | 3.63 |
| 2025-01 | 0 | 3.43 |
| 2025-02 | 1 | 3.08 |
| 2025-03 | 1 | 3.36 |
| 2025-04 | 0 | 3.7 |
| 2025-05 | 0 | 4.57 |
| 2025-06 | 0 | 4.17 |
| 2025-07 | 0 | 4.7 |
| 2025-08 | 0 | 4.3 |
| 2025-09 | 0 | 3.83 |
| 2025-10 | 0 | 4.58 |
| 2025-11 | 0 | 5.2 |
| 2025-12 | 0 | 8.42 |
| 2026-01 | 0 | 7.63 |
| 2026-02 | 0 | 5.27 |
| 2026-03 | 0 | 5.85 |
| 2026-04 | 0 | 7.26 |
| 2026-05 | 0 | 7.81 |
| 2026-06 | 0 | 6.19 |
Failure-mode summaryAI-generated
40 linked report narratives available — no AI summary generated yet.
Recall history
| Initiated | Recall # | Class | Status | Reason | Quantity | Link basis |
|---|---|---|---|---|---|---|
| 2026-01-21 | Z-1383-2026 | Class II | Open, Classified | Device for bronchoscopic visualization, patient airway access has software issue: if application restarts after patient-side selection, prior to bronchoscope loading, application will re-initialize to patient-left position; and if right position was previously selected, this may lead to unanticipated robotic arm positioning toward patient-left, may result in contact with patient/endotracheal tube.Distribution: Worldwide - US Nationwide distribution in the states of MN, FL, NJ, NY, VA, WI, AZ, AL, MS, LA, MI, MA, MT, PA, WV, GA, DE, TX, CA, OH, IN, SC, CT, ND, MO, DC, IL, NE, ID, WA, NC, TN, OR, CO, SD, NM, VT, MD and the countries of Hong Kong, China, Canada. | 173 | code info di |
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2025-03-14 | 3014447948-2025-00005 | Injury | Available | model number |
| 2025-02-21 | 3014447948-2025-00004 | Injury | Available | model number |
| 2024-12-26 | 3014447948-2024-00028 | Malfunction | Available | model number |
| 2024-12-03 | 3014447948-2024-00026 | Malfunction | Available | model number |
| 2024-10-31 | 3014447948-2024-00024 | Injury | Available | model number |
| 2024-10-14 | 3014447948-2024-00022 | Malfunction | Available | model number |
| 2024-08-22 | 3014447948-2024-00018 | Malfunction | Available | model number |
| 2024-07-30 | 3014447948-2024-00017 | Injury | Available | model number |
| 2024-06-25 | 3014447948-2024-00014 | Injury | Available | model number |
| 2024-04-16 | 3014447948-2024-00008 | Injury | Available | model number |
| 2024-03-20 | 3014447948-2024-00007 | Injury | Available | model number |
| 2024-03-20 | 3014447948-2024-00006 | Injury | Available | model number |
| 2024-03-12 | 3014447948-2024-00003 | Injury | Available | model number |
| 2024-02-29 | 3014447948-2024-00001 | Injury | Available | model number |
| 2023-12-22 | 3014447948-2023-00034 | Injury | Available | model number |
Showing 1–15 of 74
Regulatory clearances
Predicate lineage
- K211493
Cited as predicate by: K243219
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 |
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