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.
12 linked reportsMalfunction 11Injury 1
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 0 | 4.03 |
| 2019-02 | 0 | 3.56 |
| 2019-03 | 0 | 6.13 |
| 2019-04 | 0 | 5.18 |
| 2019-05 | 0 | 3.91 |
| 2019-06 | 0 | 4.08 |
| 2019-07 | 0 | 4 |
| 2019-08 | 0 | 4.83 |
| 2019-09 | 0 | 4.22 |
| 2019-10 | 0 | 4.22 |
| 2019-11 | 0 | 5.12 |
| 2019-12 | 0 | 4.98 |
| 2020-01 | 0 | 4.05 |
| 2020-02 | 0 | 3.83 |
| 2020-03 | 0 | 4.61 |
| 2020-04 | 0 | 4.36 |
| 2020-05 | 0 | 2.98 |
| 2020-06 | 0 | 5.6 |
| 2020-07 | 0 | 5.13 |
| 2020-08 | 0 | 4.17 |
| 2020-09 | 0 | 4.44 |
| 2020-10 | 0 | 4.79 |
| 2020-11 | 0 | 4.96 |
| 2020-12 | 0 | 4.91 |
| 2021-01 | 0 | 4.37 |
| 2021-02 | 0 | 4.81 |
| 2021-03 | 0 | 5.69 |
| 2021-04 | 0 | 4.27 |
| 2021-05 | 0 | 4.53 |
| 2021-06 | 0 | 4.81 |
| 2021-07 | 0 | 4.32 |
| 2021-08 | 0 | 4.54 |
| 2021-09 | 0 | 3.76 |
| 2021-10 | 0 | 2.83 |
| 2021-11 | 0 | 3.95 |
| 2021-12 | 0 | 3.59 |
| 2022-01 | 0 | 3.21 |
| 2022-02 | 0 | 3.08 |
| 2022-03 | 0 | 3.22 |
| 2022-04 | 0 | 3.51 |
| 2022-05 | 0 | 2.8 |
| 2022-06 | 0 | 4 |
| 2022-07 | 0 | 3.79 |
| 2022-08 | 0 | 3.86 |
| 2022-09 | 0 | 3.46 |
| 2022-10 | 0 | 3.69 |
| 2022-11 | 0 | 4.15 |
| 2022-12 | 0 | 4.11 |
| 2023-01 | 0 | 3.14 |
| 2023-02 | 0 | 3.7 |
| 2023-03 | 0 | 4.22 |
| 2023-04 | 0 | 3.68 |
| 2023-05 | 0 | 4.75 |
| 2023-06 | 0 | 3.86 |
| 2023-07 | 0 | 3.96 |
| 2023-08 | 1 | 3.54 |
| 2023-09 | 0 | 3.79 |
| 2023-10 | 0 | 3.41 |
| 2023-11 | 0 | 3.71 |
| 2023-12 | 0 | 3.18 |
| 2024-01 | 0 | 3.57 |
| 2024-02 | 0 | 4.25 |
| 2024-03 | 0 | 4.12 |
| 2024-04 | 0 | 3.93 |
| 2024-05 | 0 | 3.2 |
| 2024-06 | 0 | 3.28 |
| 2024-07 | 0 | 3.35 |
| 2024-08 | 0 | 3 |
| 2024-09 | 0 | 3.97 |
| 2024-10 | 0 | 3.45 |
| 2024-11 | 0 | 3.22 |
| 2024-12 | 0 | 3.28 |
| 2025-01 | 0 | 2.69 |
| 2025-02 | 0 | 4.77 |
| 2025-03 | 0 | 3.67 |
| 2025-04 | 0 | 2.68 |
| 2025-05 | 0 | 4.03 |
| 2025-06 | 1 | 3.3 |
| 2025-07 | 1 | 3.49 |
| 2025-08 | 2 | 3.46 |
| 2025-09 | 0 | 2.91 |
| 2025-10 | 0 | 3.63 |
| 2025-11 | 1 | 3.08 |
| 2025-12 | 0 | 3.4 |
| 2026-01 | 0 | 2.55 |
| 2026-02 | 0 | 3.25 |
| 2026-03 | 0 | 3.07 |
| 2026-04 | 0 | 4.28 |
| 2026-05 | 2 | 3.4 |
| 2026-06 | 4 | 3.89 |
Failure-mode summaryAI-generated
11 linked report narratives available — no AI summary generated yet.
Recall history
No recalls linked.
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2026-06-24 | 1625507-2026-03547 | Malfunction | — | exact di |
| 2026-06-11 | 1625507-2026-02488 | Malfunction | Available | exact di |
| 2026-06-09 | 1625507-2026-02164 | Malfunction | Available | exact di |
| 2026-06-08 | 1625507-2026-02148 | Malfunction | Available | exact di |
| 2026-05-29 | 1625507-2026-01607 | Malfunction | Available | exact di |
| 2026-05-20 | 1625507-2026-01166 | Injury | Available | exact di |
| 2025-11-10 | 1625507-2025-02278 | Malfunction | Available | exact di |
| 2025-08-21 | 1625507-2025-01960 | Malfunction | Available | exact di |
| 2025-08-13 | 1625507-2025-01938 | Malfunction | Available | exact di |
| 2025-07-03 | 1625507-2025-01766 | Malfunction | Available | exact di |
| 2025-06-09 | 1625507-2025-01660 | Malfunction | Available | exact di |
| 2023-08-30 | 17649717 | Malfunction | Available | model number |
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 |
|---|---|---|---|---|
| 2024-12-05 | NAI | No action indicated | Medtronic Powered Surgical Solutions | 0 |
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