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.
2 linked reportsMalfunction 2
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2020-08 | 0 | 2 |
| 2020-09 | 0 | 2 |
| 2022-03 | 2 | 2 |
| 2024-10 | 0 | 3.5 |
| 2025-03 | 0 | 1 |
| 2025-04 | 0 | 1 |
| 2025-07 | 0 | 1 |
| 2025-09 | 0 | 1 |
| 2026-02 | 0 | 1 |
Failure-mode summaryAI-generated
2 linked report narratives available — no AI summary generated yet.
Recall history
No recalls linked.
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2022-03-15 | 9610612-2022-00075 | Malfunction | Available | catalog number |
Showing the most recent 1 of 2 linked reports.
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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