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.
45 linked reportsInjury 44Malfunction 1
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 0 | 1.38 |
| 2019-02 | 0 | 2.07 |
| 2019-03 | 0 | 1.86 |
| 2019-04 | 0 | 1.8 |
| 2019-05 | 0 | 2.52 |
| 2019-06 | 0 | 1.81 |
| 2019-07 | 0 | 2.87 |
| 2019-08 | 0 | 2.39 |
| 2019-09 | 0 | 2.16 |
| 2019-10 | 0 | 2.25 |
| 2019-11 | 0 | 1.76 |
| 2019-12 | 0 | 1.96 |
| 2020-01 | 0 | 2.51 |
| 2020-02 | 0 | 2.24 |
| 2020-03 | 0 | 2.38 |
| 2020-04 | 0 | 1.71 |
| 2020-05 | 0 | 2.13 |
| 2020-06 | 0 | 2.92 |
| 2020-07 | 0 | 1.97 |
| 2020-08 | 0 | 2.47 |
| 2020-09 | 0 | 2.13 |
| 2020-10 | 0 | 2.37 |
| 2020-11 | 0 | 2.59 |
| 2020-12 | 0 | 2.07 |
| 2021-01 | 0 | 2.09 |
| 2021-02 | 0 | 2.25 |
| 2021-03 | 0 | 2.07 |
| 2021-04 | 1 | 3.48 |
| 2021-05 | 1 | 2.14 |
| 2021-06 | 1 | 2.22 |
| 2021-07 | 1 | 2.2 |
| 2021-08 | 1 | 2.39 |
| 2021-09 | 0 | 3.76 |
| 2021-10 | 1 | 3.29 |
| 2021-11 | 1 | 3.34 |
| 2021-12 | 0 | 4.77 |
| 2022-01 | 1 | 2.43 |
| 2022-02 | 0 | 2.09 |
| 2022-03 | 0 | 1.88 |
| 2022-04 | 0 | 1.84 |
| 2022-05 | 0 | 1.85 |
| 2022-06 | 0 | 2.07 |
| 2022-07 | 2 | 1.95 |
| 2022-08 | 0 | 2.16 |
| 2022-09 | 4 | 1.82 |
| 2022-10 | 2 | 2.64 |
| 2022-11 | 0 | 2.04 |
| 2022-12 | 0 | 2.33 |
| 2023-01 | 1 | 1.96 |
| 2023-02 | 1 | 2.4 |
| 2023-03 | 0 | 1.91 |
| 2023-04 | 1 | 2.09 |
| 2023-05 | 1 | 1.95 |
| 2023-06 | 2 | 2.06 |
| 2023-07 | 2 | 2 |
| 2023-08 | 0 | 2.32 |
| 2023-09 | 0 | 1.98 |
| 2023-10 | 2 | 2.02 |
| 2023-11 | 1 | 5.85 |
| 2023-12 | 4 | 2.78 |
| 2024-01 | 0 | 1.83 |
| 2024-02 | 3 | 1.93 |
| 2024-03 | 1 | 1.88 |
| 2024-04 | 0 | 2.01 |
| 2024-05 | 0 | 2.03 |
| 2024-06 | 0 | 1.82 |
| 2024-07 | 0 | 2.17 |
| 2024-08 | 0 | 1.84 |
| 2024-09 | 0 | 2.21 |
| 2024-10 | 0 | 2.08 |
| 2024-11 | 0 | 2.31 |
| 2024-12 | 2 | 2.14 |
| 2025-01 | 0 | 1.75 |
| 2025-02 | 3 | 2.61 |
| 2025-03 | 0 | 2.57 |
| 2025-04 | 1 | 2.4 |
| 2025-05 | 0 | 2.64 |
| 2025-06 | 0 | 2.82 |
| 2025-07 | 0 | 2.35 |
| 2025-08 | 0 | 1.95 |
| 2025-09 | 1 | 1.86 |
| 2025-10 | 0 | 2.57 |
| 2025-11 | 0 | 2.5 |
| 2025-12 | 0 | 2.67 |
| 2026-01 | 0 | 2.19 |
| 2026-02 | 0 | 2.52 |
| 2026-03 | 0 | 2.57 |
| 2026-04 | 2 | 1.95 |
| 2026-05 | 1 | 2.21 |
| 2026-06 | 0 | 1.92 |
Failure-mode summaryAI-generated
40 linked report narratives available — no AI summary generated yet.
Recall history
No recalls linked.
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2026-05-18 | 3004721439-2026-00140 | Injury | Available | exact di |
| 2026-04-20 | 3004721439-2026-00102 | Injury | Available | exact di |
| 2026-04-20 | 3004721439-2026-00098 | Malfunction | Available | exact di |
| 2025-09-11 | 3004721439-2025-00257 | Injury | Available | exact di |
| 2025-04-28 | 3004721439-2025-00123 | Injury | Available | exact di |
| 2025-02-18 | 3004721439-2025-00032 | Injury | Available | exact di |
| 2025-02-18 | 3004721439-2025-00026 | Injury | Available | exact di |
| 2025-02-18 | 3004721439-2025-00031 | Injury | Available | exact di |
| 2024-12-30 | 3004721439-2024-00419 | Injury | Available | exact di |
| 2024-12-30 | 3004721439-2024-00404 | Injury | Available | exact di |
| 2024-03-15 | 3004721439-2024-00067 | Injury | Available | exact di |
| 2024-02-22 | 3004721439-2024-00039 | Injury | Available | exact di |
| 2024-02-02 | 3004721439-2024-00018 | Injury | Available | exact di |
| 2024-02-02 | 3004721439-2024-00017 | Injury | Available | exact di |
| 2023-12-18 | 3004721439-2023-00385 | Injury | Available | exact di |
Showing 1–15 of 45
Regulatory clearances
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 |
|---|---|---|---|---|
| 2025-07-11 | NAI | No action indicated | Aesculap Inc | 0 |
| 2025-07-11 | NAI | No action indicated | Aesculap Inc | 0 |
| 2022-07-21 | NAI | No action indicated | Aesculap AG | 0 |
| 2022-07-21 | NAI | No action indicated | Aesculap AG | 0 |
| 2021-08-11 | VAI | Voluntary action indicated | Aesculap Inc | 3 |
| 2021-08-11 | VAI | Voluntary action indicated | Aesculap Inc | 3 |
| 2018-06-13 | VAI | Voluntary action indicated | Aesculap Inc | 0 |
| 2018-06-13 | VAI | Voluntary action indicated | Aesculap Inc | 0 |
| 2016-09-22 | NAI | No action indicated | Aesculap AG | 0 |
| 2016-09-22 | NAI | No action indicated | Aesculap AG | 0 |
| 2016-09-14 | VAI | Voluntary action indicated | Aesculap Inc | 0 |
| 2016-09-14 | VAI | Voluntary action indicated | Aesculap Inc | 0 |
| 2016-07-13 | NAI | No action indicated | Aesculap Inc | 0 |
| 2016-07-13 | NAI | No action indicated | Aesculap Inc | 0 |
| 2015-07-16 | NAI | No action indicated | Aesculap AG | 1 |
| 2015-07-16 | NAI | No action indicated | Aesculap AG | 1 |
| 2015-05-05 | NAI | No action indicated | Aesculap Inc | 0 |
| 2015-05-05 | NAI | No action indicated | Aesculap Inc | 0 |
| 2014-10-23 | NAI | No action indicated | Aesculap Inc | 0 |
| 2014-10-23 | NAI | No action indicated | Aesculap Inc | 0 |
| 2011-09-26 | WL | Warning Letter | Aesculap AG | — |
| 2011-09-26 | WL | Warning Letter | Aesculap AG | — |
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