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.
17 linked reportsMalfunction 17
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-11 | 0 | 1 |
| 2021-07 | 0 | 1 |
| 2021-10 | 0 | 1 |
| 2022-02 | 0 | 1 |
| 2022-03 | 0 | 1 |
| 2022-06 | 0 | 1 |
| 2022-08 | 0 | 2 |
| 2022-12 | 0 | 1 |
| 2023-02 | 0 | 2 |
| 2023-03 | 0 | 1 |
| 2024-01 | 0 | 2 |
| 2024-02 | 0 | 2 |
| 2024-03 | 0 | 2 |
| 2024-04 | 0 | 1 |
| 2024-08 | 0 | 1 |
| 2024-10 | 0 | 1 |
| 2025-01 | 0 | 1 |
| 2025-05 | 10 | 10 |
| 2025-07 | 0 | 2 |
| 2025-09 | 0 | 1 |
| 2026-01 | 0 | 2 |
| 2026-04 | 7 | 4 |
Failure-mode summaryAI-generated
17 linked report narratives available — no AI summary generated yet.
Recall history
No recalls linked.
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2026-04-24 | 3011050570-2026-00466 | Malfunction | Available | exact di |
| 2026-04-24 | 3011050570-2026-00468 | Malfunction | Available | exact di |
| 2026-04-24 | 3011050570-2026-00467 | Malfunction | Available | exact di |
| 2026-04-24 | 3011050570-2026-00469 | Malfunction | Available | model number |
| 2025-05-27 | 3011050570-2025-00540 | Malfunction | Available | exact di |
| 2025-05-27 | 3011050570-2025-00539 | Malfunction | Available | exact di |
| 2025-05-23 | 3011050570-2025-00532 | Malfunction | Available | exact di |
| 2025-05-23 | 3011050570-2025-00531 | Malfunction | Available | exact di |
| 2025-05-23 | 3011050570-2025-00530 | Malfunction | Available | exact di |
Showing the most recent 9 of 17 linked reports.
Regulatory clearances
Predicate lineage
- K171440
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 |
|---|---|---|---|---|
| 2023-11-02 | VAI | Voluntary action indicated | Gyrus ACMI, Inc. | 3 |
| 2022-05-02 | NAI | No action indicated | Gyrus ACMI, Inc. | 0 |
| 2020-01-14 | NAI | No action indicated | Gyrus ACMI, Inc. | 0 |
| 2018-05-23 | NAI | No action indicated | Gyrus ACMI, Inc. | 0 |
| 2018-04-17 | VAI | Voluntary action indicated | Gyrus ACMI, Inc. | 1 |
| 2017-07-27 | NAI | No action indicated | Gyrus ACMI, Inc. | 0 |
| 2016-08-17 | NAI | No action indicated | Gyrus ACMI, Inc. | 0 |
| 2016-07-01 | NAI | No action indicated | Gyrus ACMI, Inc. | 0 |
| 2015-12-11 | NAI | No action indicated | Gyrus ACMI, Inc. | 0 |
| 2015-04-03 | VAI | Voluntary action indicated | Gyrus ACMI, Inc. | 1 |
| 2015-03-20 | NAI | No action indicated | Gyrus ACMI, Inc. | 0 |
| 2013-09-18 | VAI | Voluntary action indicated | Gyrus ACMI, Inc. | 4 |
| 2013-06-21 | VAI | Voluntary action indicated | Gyrus ACMI, Inc. | 1 |
| 2013-06-11 | VAI | Voluntary action indicated | Gyrus Acmi, Inc. | 2 |
| 2012-08-31 | NAI | No action indicated | Gyrus ACMI, Inc. | 0 |
| 2012-06-14 | VAI | Voluntary action indicated | Gyrus ACMI, Inc. | 2 |
| 2011-06-13 | NAI | No action indicated | Gyrus ACMI, Inc. | 0 |
| 2010-09-15 | NAI | No action indicated | Gyrus ACMI, Inc. | 0 |
| 2010-06-24 | NAI | No action indicated | Gyrus Acmi, Inc. | 0 |
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