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.
2,482 linked reportsMalfunction 2,468Injury 14
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 0 | 2.73 |
| 2019-02 | 0 | 3.29 |
| 2019-03 | 0 | 4.74 |
| 2019-04 | 0 | 10.44 |
| 2019-05 | 0 | 3.16 |
| 2019-06 | 0 | 3.46 |
| 2019-07 | 0 | 3.27 |
| 2019-08 | 0 | 3.05 |
| 2019-09 | 0 | 2.7 |
| 2019-10 | 1 | 2.95 |
| 2019-11 | 0 | 2.78 |
| 2019-12 | 0 | 2.94 |
| 2020-01 | 0 | 2.88 |
| 2020-02 | 0 | 3.76 |
| 2020-03 | 0 | 2.61 |
| 2020-04 | 1 | 3.19 |
| 2020-05 | 3 | 3.17 |
| 2020-06 | 2 | 3.7 |
| 2020-07 | 12 | 4.73 |
| 2020-08 | 1 | 5.23 |
| 2020-09 | 4 | 5.04 |
| 2020-10 | 3 | 5.87 |
| 2020-11 | 5 | 6.22 |
| 2020-12 | 12 | 6.95 |
| 2021-01 | 4 | 6.4 |
| 2021-02 | 13 | 5.79 |
| 2021-03 | 19 | 8.07 |
| 2021-04 | 25 | 7.13 |
| 2021-05 | 20 | 6.86 |
| 2021-06 | 19 | 6.04 |
| 2021-07 | 12 | 5.84 |
| 2021-08 | 8 | 6.8 |
| 2021-09 | 11 | 7.51 |
| 2021-10 | 16 | 6.43 |
| 2021-11 | 18 | 6.03 |
| 2021-12 | 22 | 7.87 |
| 2022-01 | 34 | 7.54 |
| 2022-02 | 19 | 8.2 |
| 2022-03 | 33 | 9.8 |
| 2022-04 | 43 | 10.68 |
| 2022-05 | 40 | 9.52 |
| 2022-06 | 44 | 10.36 |
| 2022-07 | 44 | 9.49 |
| 2022-08 | 54 | 9.34 |
| 2022-09 | 34 | 8.39 |
| 2022-10 | 30 | 8.41 |
| 2022-11 | 35 | 8.09 |
| 2022-12 | 53 | 9.03 |
| 2023-01 | 39 | 9.06 |
| 2023-02 | 39 | 7.77 |
| 2023-03 | 59 | 10.28 |
| 2023-04 | 47 | 8.8 |
| 2023-05 | 42 | 8.62 |
| 2023-06 | 43 | 8.69 |
| 2023-07 | 39 | 8.39 |
| 2023-08 | 50 | 9.79 |
| 2023-09 | 51 | 9.44 |
| 2023-10 | 54 | 9.71 |
| 2023-11 | 53 | 9.84 |
| 2023-12 | 43 | 9.07 |
| 2024-01 | 42 | 9.15 |
| 2024-02 | 65 | 10.16 |
| 2024-03 | 67 | 10.4 |
| 2024-04 | 47 | 10.43 |
| 2024-05 | 62 | 10.33 |
| 2024-06 | 93 | 12.6 |
| 2024-07 | 78 | 11.83 |
| 2024-08 | 67 | 11.4 |
| 2024-09 | 65 | 11.56 |
| 2024-10 | 82 | 13.58 |
| 2024-11 | 51 | 9.3 |
| 2024-12 | 39 | 8.09 |
| 2025-01 | 27 | 8.3 |
| 2025-02 | 9 | 7.07 |
| 2025-03 | 32 | 7.83 |
| 2025-04 | 30 | 8.04 |
| 2025-05 | 22 | 7.6 |
| 2025-06 | 31 | 7.49 |
| 2025-07 | 33 | 8.08 |
| 2025-08 | 44 | 8.68 |
| 2025-09 | 17 | 6.53 |
| 2025-10 | 29 | 9.22 |
| 2025-11 | 18 | 11.77 |
| 2025-12 | 35 | 19.05 |
| 2026-01 | 18 | 15.04 |
| 2026-02 | 17 | 10.75 |
| 2026-03 | 22 | 11.99 |
| 2026-04 | 34 | 15.07 |
| 2026-05 | 31 | 15.73 |
| 2026-06 | 22 | 13.46 |
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 |
|---|---|---|---|---|
| 2026-06-26 | 3002808148-2026-21982 | Malfunction | Available | exact di |
| 2026-06-22 | 3002808148-2026-21256 | Malfunction | Available | exact di |
| 2026-06-22 | 3002808148-2026-21255 | Malfunction | Available | exact di |
| 2026-06-18 | 3002808148-2026-20948 | Malfunction | Available | exact di |
| 2026-06-17 | 3002808148-2026-20818 | Malfunction | Available | exact di |
| 2026-06-15 | 3002808148-2026-20420 | Malfunction | Available | exact di |
| 2026-06-12 | 3002808148-2026-20262 | Malfunction | Available | exact di |
| 2026-06-11 | 3002808148-2026-20143 | Malfunction | Available | exact di |
| 2026-06-11 | 3002808148-2026-20141 | Malfunction | Available | exact di |
| 2026-06-11 | 3002808148-2026-20051 | Malfunction | Available | exact di |
| 2026-06-10 | 3002808148-2026-20032 | Malfunction | Available | exact di |
| 2026-06-09 | 3002808148-2026-19830 | Malfunction | Available | exact di |
| 2026-06-08 | 3002808148-2026-19628 | Malfunction | Available | exact di |
| 2026-06-06 | 3002808148-2026-19585 | Malfunction | Available | exact di |
| 2026-06-04 | 3002808148-2026-19326 | Malfunction | Available | exact di |
Showing the most recent 200 of 2,482 linked reports.
Showing 1–15 of 200
Regulatory clearances
- 510(k)K172817Substantially equivalent (SESE) · 2017-10-17clearance family
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 |
|---|---|---|---|---|
| 2022-12-12 | WL | Warning Letter | Olympus Medical Systems Corporation | — |
| 2022-09-09 | OAI | Official action indicated | Olympus Medical Systems Corporation | 1 |
| 2018-03-09 | WL | Warning Letter | Olympus Medical Systems Corporation | — |
| 2015-04-24 | OAI | Official action indicated | Olympus Medical Systems Corporation | 2 |
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