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.
97 linked reportsMalfunction 58Injury 39
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 2 | 6.66 |
| 2019-02 | 2 | 4.26 |
| 2019-03 | 0 | 4.33 |
| 2019-04 | 0 | 5.9 |
| 2019-05 | 2 | 4.7 |
| 2019-06 | 0 | 4.86 |
| 2019-07 | 0 | 5.77 |
| 2019-08 | 4 | 5.99 |
| 2019-09 | 0 | 4.96 |
| 2019-10 | 2 | 5.86 |
| 2019-11 | 2 | 5.56 |
| 2019-12 | 2 | 5.26 |
| 2020-01 | 2 | 4.77 |
| 2020-02 | 0 | 5.43 |
| 2020-03 | 2 | 5.59 |
| 2020-04 | 0 | 3.51 |
| 2020-05 | 0 | 3.68 |
| 2020-06 | 0 | 5.04 |
| 2020-07 | 0 | 6.43 |
| 2020-08 | 0 | 4.57 |
| 2020-09 | 0 | 5.81 |
| 2020-10 | 0 | 5.48 |
| 2020-11 | 9 | 5.05 |
| 2020-12 | 2 | 5.19 |
| 2021-01 | 4 | 5.08 |
| 2021-02 | 2 | 4.87 |
| 2021-03 | 2 | 5.63 |
| 2021-04 | 0 | 5.21 |
| 2021-05 | 11 | 5.23 |
| 2021-06 | 0 | 5.82 |
| 2021-07 | 5 | 4.91 |
| 2021-08 | 0 | 4.28 |
| 2021-09 | 0 | 4.77 |
| 2021-10 | 0 | 6.36 |
| 2021-11 | 0 | 5.57 |
| 2021-12 | 6 | 5.73 |
| 2022-01 | 0 | 4.9 |
| 2022-02 | 0 | 5.15 |
| 2022-03 | 0 | 5.78 |
| 2022-04 | 0 | 4.96 |
| 2022-05 | 0 | 5.87 |
| 2022-06 | 0 | 6.49 |
| 2022-07 | 6 | 4.5 |
| 2022-08 | 4 | 4.8 |
| 2022-09 | 0 | 4.93 |
| 2022-10 | 0 | 4.88 |
| 2022-11 | 0 | 4.77 |
| 2022-12 | 0 | 4.07 |
| 2023-01 | 0 | 5.57 |
| 2023-02 | 0 | 4.69 |
| 2023-03 | 4 | 4.9 |
| 2023-04 | 0 | 4.75 |
| 2023-05 | 2 | 5.2 |
| 2023-06 | 2 | 4.81 |
| 2023-07 | 2 | 4.73 |
| 2023-08 | 2 | 4.49 |
| 2023-09 | 0 | 5.17 |
| 2023-10 | 0 | 5.11 |
| 2023-11 | 0 | 4.34 |
| 2023-12 | 0 | 4.77 |
| 2024-01 | 2 | 5.48 |
| 2024-02 | 0 | 5.41 |
| 2024-03 | 2 | 5.98 |
| 2024-04 | 2 | 5.98 |
| 2024-05 | 0 | 6.21 |
| 2024-06 | 0 | 5.24 |
| 2024-07 | 0 | 5.02 |
| 2024-08 | 0 | 4.93 |
| 2024-09 | 0 | 5.13 |
| 2024-10 | 0 | 5.6 |
| 2024-11 | 0 | 5.24 |
| 2024-12 | 0 | 4.01 |
| 2025-01 | 0 | 5.11 |
| 2025-02 | 2 | 4.44 |
| 2025-03 | 0 | 6.2 |
| 2025-04 | 0 | 4.41 |
| 2025-05 | 2 | 5.15 |
| 2025-06 | 0 | 5 |
| 2025-07 | 0 | 5.17 |
| 2025-08 | 0 | 5.41 |
| 2025-09 | 0 | 4.79 |
| 2025-10 | 0 | 5.13 |
| 2025-11 | 0 | 5.57 |
| 2025-12 | 0 | 5.77 |
| 2026-01 | 0 | 5.56 |
| 2026-02 | 0 | 5.92 |
| 2026-03 | 0 | 6.14 |
| 2026-04 | 0 | 5.41 |
| 2026-05 | 0 | 6.19 |
| 2026-06 | 4 | 5.58 |
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 |
|---|---|---|---|---|
| 2026-06-18 | 9610612-2026-00144 | Malfunction | Available | catalog number |
| 2026-06-17 | 9610612-2026-00119 | Injury | Available | catalog number |
| 2025-05-05 | 9610612-2025-00074 | Injury | Available | catalog number |
| 2025-02-13 | 9610612-2025-00036 | Injury | Available | catalog number |
| 2024-04-09 | 9610612-2024-00111 | Injury | Available | catalog number |
| 2024-03-14 | 9610612-2024-00054 | Malfunction | Available | catalog number |
| 2024-01-25 | 9610612-2023-00291 | Malfunction | Available | catalog number |
| 2023-08-08 | 9610612-2023-00189 | Injury | Available | catalog number |
| 2023-07-20 | 9610612-2023-00182 | Malfunction | Available | catalog number |
| 2023-06-13 | 9610612-2023-00146 | Injury | Available | catalog number |
| 2023-05-26 | 9610612-2023-00119 | Injury | Available | catalog number |
| 2023-03-20 | 9610612-2023-00059 | Injury | Available | catalog number |
| 2023-03-15 | 9610612-2023-00056 | Malfunction | Available | catalog number |
| 2022-08-17 | 9610612-2022-00242 | Malfunction | Available | catalog number |
| 2022-08-15 | 9610612-2022-00241 | Injury | Available | catalog number |
Showing the most recent 45 of 97 linked reports.
Showing 1–15 of 45
Regulatory clearances
None linked.
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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