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.
1 linked reportInjury 1
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 0 | 1 |
| 2019-02 | 0 | 1 |
| 2019-04 | 0 | 1 |
| 2019-05 | 0 | 2.25 |
| 2019-06 | 0 | 1 |
| 2019-07 | 0 | 1.33 |
| 2019-08 | 0 | 2.8 |
| 2019-09 | 0 | 2 |
| 2019-10 | 0 | 1.25 |
| 2019-11 | 0 | 1.33 |
| 2019-12 | 0 | 1.4 |
| 2020-01 | 0 | 1.5 |
| 2020-02 | 0 | 2.6 |
| 2020-04 | 0 | 2.5 |
| 2020-05 | 0 | 2.25 |
| 2020-06 | 0 | 3.42 |
| 2020-07 | 0 | 3.59 |
| 2020-08 | 0 | 4.67 |
| 2020-09 | 0 | 3.75 |
| 2020-10 | 0 | 7.5 |
| 2020-11 | 0 | 7.5 |
| 2020-12 | 0 | 4.95 |
| 2021-01 | 0 | 6.08 |
| 2021-02 | 0 | 5.62 |
| 2021-03 | 0 | 7.92 |
| 2021-04 | 0 | 8.33 |
| 2021-05 | 0 | 5.44 |
| 2021-06 | 0 | 4.73 |
| 2021-07 | 0 | 4.93 |
| 2021-08 | 0 | 7 |
| 2021-09 | 0 | 6.13 |
| 2021-10 | 0 | 5.56 |
| 2021-11 | 0 | 6.69 |
| 2021-12 | 0 | 6.47 |
| 2022-01 | 0 | 8.16 |
| 2022-02 | 0 | 10.11 |
| 2022-03 | 0 | 13.13 |
| 2022-04 | 0 | 16.29 |
| 2022-05 | 0 | 12.16 |
| 2022-06 | 0 | 13.61 |
| 2022-07 | 0 | 13.61 |
| 2022-08 | 0 | 15.76 |
| 2022-09 | 0 | 12.17 |
| 2022-10 | 0 | 10.9 |
| 2022-11 | 0 | 10.41 |
| 2022-12 | 0 | 11.94 |
| 2023-01 | 0 | 11.14 |
| 2023-02 | 0 | 7.52 |
| 2023-03 | 0 | 11.57 |
| 2023-04 | 0 | 12 |
| 2023-05 | 0 | 8.4 |
| 2023-06 | 0 | 10.13 |
| 2023-07 | 0 | 8.27 |
| 2023-08 | 0 | 10.2 |
| 2023-09 | 0 | 11.52 |
| 2023-10 | 0 | 10.52 |
| 2023-11 | 0 | 10.57 |
| 2023-12 | 0 | 7.78 |
| 2024-01 | 0 | 7.22 |
| 2024-02 | 1 | 8.83 |
| 2024-03 | 0 | 9.24 |
| 2024-04 | 0 | 7.37 |
| 2024-05 | 0 | 6.67 |
| 2024-06 | 0 | 8.32 |
| 2024-07 | 0 | 8.96 |
| 2024-08 | 0 | 9 |
| 2024-09 | 0 | 7.93 |
| 2024-10 | 0 | 9.75 |
| 2024-11 | 0 | 5.89 |
| 2024-12 | 0 | 4.84 |
| 2025-01 | 0 | 3 |
| 2025-02 | 0 | 2.45 |
| 2025-03 | 0 | 4.14 |
| 2025-04 | 0 | 3.9 |
| 2025-05 | 0 | 3.52 |
| 2025-06 | 0 | 3.74 |
| 2025-07 | 0 | 4.08 |
| 2025-08 | 0 | 4.71 |
| 2025-09 | 0 | 3.55 |
| 2025-10 | 0 | 4.69 |
| 2025-11 | 0 | 3.5 |
| 2025-12 | 0 | 6.72 |
| 2026-01 | 0 | 8.54 |
| 2026-02 | 0 | 5.79 |
| 2026-03 | 0 | 5.25 |
| 2026-04 | 0 | 6.95 |
| 2026-05 | 0 | 8.17 |
| 2026-06 | 0 | 6.81 |
Failure-mode summaryAI-generated
1 linked report narrative available — no AI summary generated yet.
Recall history
| Initiated | Recall # | Class | Status | Reason | Quantity | Link basis |
|---|---|---|---|---|---|---|
| 2024-08-02 | Z-0052-2025 | Class II | Open, Classified | Endoscopy/bronchoscopy/urology devices may have a strain relief defect with some cart and tower power cords that may cause an electrical short, which may lead to system shutdown, which can lead to prolonged procedure or case conversion, and if the user (e.g., operating room staff) touches exposed wires or conductive fluids in contact with the exposed wires, there is a chance of electrical shock.Distribution: Worldwide - US Nationwide distribution including in the states of MN, FL, NC, AK, NJ, NY, VA, WI, AZ, MS, LA, MI, MA, MT, WV, GA, DE, TX, CA, OH, IN, SC, PA, CT, ND, MO, DC, IL, NE, ID, WA, TN, OR, AL, SD, CO, KY, NM, VT, MD and the countries of Canada. | 4 | clearance family |
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2024-02-29 | 3014447948-2024-00002 | Injury | Available | model number |
Regulatory clearances
- 510(k)K213334Substantially equivalent (SESE) · 2022-04-29clearance family
Predicate lineage
- K213334
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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