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.
39 linked reportsMalfunction 39
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 0 | 2.88 |
| 2019-02 | 0 | 3.44 |
| 2019-03 | 0 | 3.82 |
| 2019-04 | 0 | 5.83 |
| 2019-05 | 0 | 2.88 |
| 2019-06 | 0 | 3.5 |
| 2019-07 | 0 | 3.39 |
| 2019-08 | 0 | 2.69 |
| 2019-09 | 0 | 2.57 |
| 2019-10 | 0 | 2.81 |
| 2019-11 | 0 | 2.59 |
| 2019-12 | 0 | 2.63 |
| 2020-01 | 0 | 2.68 |
| 2020-02 | 0 | 3.33 |
| 2020-03 | 0 | 2.53 |
| 2020-04 | 0 | 2.93 |
| 2020-05 | 0 | 3.09 |
| 2020-06 | 0 | 3.46 |
| 2020-07 | 0 | 4.6 |
| 2020-08 | 0 | 5.18 |
| 2020-09 | 0 | 4.94 |
| 2020-10 | 0 | 5.62 |
| 2020-11 | 0 | 6.3 |
| 2020-12 | 0 | 6.52 |
| 2021-01 | 1 | 6.64 |
| 2021-02 | 1 | 5.91 |
| 2021-03 | 0 | 8.23 |
| 2021-04 | 0 | 7.52 |
| 2021-05 | 0 | 6.84 |
| 2021-06 | 0 | 6.47 |
| 2021-07 | 0 | 6.33 |
| 2021-08 | 0 | 6.73 |
| 2021-09 | 2 | 7.65 |
| 2021-10 | 0 | 6.29 |
| 2021-11 | 0 | 6.12 |
| 2021-12 | 1 | 7.97 |
| 2022-01 | 2 | 7.88 |
| 2022-02 | 1 | 8.98 |
| 2022-03 | 0 | 10.17 |
| 2022-04 | 0 | 11.48 |
| 2022-05 | 1 | 10.23 |
| 2022-06 | 0 | 10.93 |
| 2022-07 | 1 | 10.06 |
| 2022-08 | 3 | 10.06 |
| 2022-09 | 0 | 8.78 |
| 2022-10 | 0 | 8.72 |
| 2022-11 | 0 | 8.75 |
| 2022-12 | 2 | 9.73 |
| 2023-01 | 1 | 9.3 |
| 2023-02 | 0 | 8.07 |
| 2023-03 | 0 | 10.71 |
| 2023-04 | 3 | 9.14 |
| 2023-05 | 2 | 9.08 |
| 2023-06 | 0 | 9.36 |
| 2023-07 | 1 | 8.81 |
| 2023-08 | 1 | 9.73 |
| 2023-09 | 0 | 9.62 |
| 2023-10 | 0 | 10.06 |
| 2023-11 | 0 | 9.9 |
| 2023-12 | 0 | 9.19 |
| 2024-01 | 4 | 9.5 |
| 2024-02 | 0 | 10.12 |
| 2024-03 | 0 | 10.34 |
| 2024-04 | 0 | 10.59 |
| 2024-05 | 0 | 10.32 |
| 2024-06 | 1 | 12.95 |
| 2024-07 | 0 | 12.12 |
| 2024-08 | 1 | 11.54 |
| 2024-09 | 0 | 11.8 |
| 2024-10 | 1 | 14.06 |
| 2024-11 | 0 | 8.68 |
| 2024-12 | 1 | 8.59 |
| 2025-01 | 2 | 8.83 |
| 2025-02 | 0 | 7.97 |
| 2025-03 | 1 | 8.71 |
| 2025-04 | 0 | 8.51 |
| 2025-05 | 1 | 8.29 |
| 2025-06 | 0 | 8.08 |
| 2025-07 | 0 | 8.47 |
| 2025-08 | 1 | 9.76 |
| 2025-09 | 0 | 7.24 |
| 2025-10 | 0 | 10.84 |
| 2025-11 | 0 | 13.56 |
| 2025-12 | 0 | 22.56 |
| 2026-01 | 1 | 17.57 |
| 2026-02 | 0 | 12.49 |
| 2026-03 | 1 | 14.02 |
| 2026-04 | 1 | 17.31 |
| 2026-05 | 0 | 18.43 |
| 2026-06 | 0 | 15.82 |
Failure-mode summaryAI-generated
39 linked report narratives available — no AI summary generated yet.
Recall history
No recalls linked.
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2026-04-20 | 3002808148-2026-12152 | Malfunction | Available | exact di |
| 2026-03-06 | 3002808148-2026-06277 | Malfunction | Available | exact di |
| 2026-01-28 | 3002808148-2026-02524 | Malfunction | Available | exact di |
| 2025-08-06 | 3002808148-2025-12309 | Malfunction | Available | exact di |
| 2025-05-13 | 3002808148-2025-07805 | Malfunction | Available | exact di |
| 2025-03-17 | 3002808148-2025-04615 | Malfunction | Available | exact di |
| 2025-01-24 | 3002808148-2025-01389 | Malfunction | Available | exact di |
| 2025-01-13 | 3002808148-2025-00769 | Malfunction | Available | exact di |
| 2024-12-05 | 3002808148-2024-38261 | Malfunction | Available | exact di |
| 2024-10-17 | 3002808148-2024-10082 | Malfunction | Available | exact di |
| 2024-08-14 | 3002808148-2024-07672 | Malfunction | Available | exact di |
| 2024-06-19 | 3002808148-2024-05595 | Malfunction | Available | exact di |
| 2024-01-24 | 3002808148-2024-00751 | Malfunction | Available | exact di |
| 2024-01-19 | 3002808148-2024-00602 | Malfunction | Available | exact di |
| 2024-01-18 | 3002808148-2024-00543 | Malfunction | Available | exact di |
Showing 1–15 of 39
Regulatory clearances
- 510(k)K123365Substantially equivalent (SESE) · 2013-03-01clearance 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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