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.
68 linked reportsMalfunction 66Injury 2
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 0 | 2.2 |
| 2019-02 | 0 | 1 |
| 2019-03 | 0 | 2.3 |
| 2019-04 | 0 | 4.78 |
| 2019-05 | 0 | 1.3 |
| 2019-06 | 0 | 2 |
| 2019-07 | 0 | 5 |
| 2019-08 | 0 | 2.4 |
| 2019-09 | 0 | 6.5 |
| 2019-10 | 2 | 1.8 |
| 2019-11 | 0 | 1 |
| 2019-12 | 0 | 2 |
| 2020-01 | 0 | 1.71 |
| 2020-02 | 0 | 1.8 |
| 2020-03 | 0 | 3.5 |
| 2020-04 | 0 | 4.8 |
| 2020-05 | 0 | 3.5 |
| 2020-06 | 0 | 4.83 |
| 2020-07 | 0 | 9.57 |
| 2020-08 | 0 | 7.17 |
| 2020-09 | 0 | 7.86 |
| 2020-10 | 0 | 10.5 |
| 2020-11 | 0 | 8.8 |
| 2020-12 | 0 | 11.75 |
| 2021-01 | 3 | 14.63 |
| 2021-02 | 0 | 13.2 |
| 2021-03 | 0 | 11.17 |
| 2021-04 | 0 | 17.5 |
| 2021-05 | 2 | 9.75 |
| 2021-06 | 0 | 9.71 |
| 2021-07 | 0 | 12 |
| 2021-08 | 0 | 14.86 |
| 2021-09 | 2 | 13.13 |
| 2021-10 | 2 | 13.22 |
| 2021-11 | 0 | 20.29 |
| 2021-12 | 0 | 33.75 |
| 2022-01 | 0 | 12.42 |
| 2022-02 | 0 | 15.43 |
| 2022-03 | 2 | 18.86 |
| 2022-04 | 2 | 22 |
| 2022-05 | 0 | 20 |
| 2022-06 | 0 | 14.63 |
| 2022-07 | 4 | 11.75 |
| 2022-08 | 2 | 13.8 |
| 2022-09 | 0 | 9.33 |
| 2022-10 | 0 | 8.33 |
| 2022-11 | 0 | 11 |
| 2022-12 | 1 | 10.25 |
| 2023-01 | 1 | 7 |
| 2023-02 | 0 | 8.83 |
| 2023-03 | 0 | 32 |
| 2023-04 | 1 | 8.83 |
| 2023-05 | 1 | 5.56 |
| 2023-06 | 3 | 18 |
| 2023-07 | 0 | 16.25 |
| 2023-08 | 1 | 7.18 |
| 2023-09 | 0 | 8.86 |
| 2023-10 | 0 | 8.78 |
| 2023-11 | 0 | 9.5 |
| 2023-12 | 0 | 13.14 |
| 2024-01 | 1 | 23.25 |
| 2024-02 | 0 | 9.83 |
| 2024-03 | 1 | 6.29 |
| 2024-04 | 2 | 5.83 |
| 2024-05 | 0 | 12.5 |
| 2024-06 | 0 | 17.17 |
| 2024-07 | 0 | 21.5 |
| 2024-08 | 1 | 24 |
| 2024-09 | 1 | 26.8 |
| 2024-10 | 0 | 28.83 |
| 2024-11 | 0 | 10 |
| 2024-12 | 1 | 7.8 |
| 2025-01 | 1 | 4.43 |
| 2025-02 | 0 | 4.8 |
| 2025-03 | 1 | 2.83 |
| 2025-04 | 1 | 2.17 |
| 2025-05 | 0 | 1.78 |
| 2025-06 | 1 | 1.78 |
| 2025-07 | 0 | 2.63 |
| 2025-08 | 0 | 10.5 |
| 2025-09 | 0 | 3.4 |
| 2025-10 | 2 | 4.1 |
| 2025-11 | 1 | 7.2 |
| 2025-12 | 6 | 3.5 |
| 2026-01 | 1 | 1.77 |
| 2026-02 | 3 | 4 |
| 2026-03 | 4 | 5.11 |
| 2026-04 | 7 | 2.33 |
| 2026-05 | 3 | 2.46 |
| 2026-06 | 1 | 2.57 |
Failure-mode summaryAI-generated
40 linked report narratives available — no AI summary generated yet.
Recall history
| Initiated | Recall # | Class | Status | Reason | Quantity | Link basis |
|---|---|---|---|---|---|---|
| 2026-01-16 | Z-1354-2026 | Class I | Open, Classified | Issue with software algorithm which may lead to overpressure events.Distribution: Nationwide distribution | 485 units | clearance family |
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2026-06-19 | 3002808148-2026-21054 | Malfunction | Available | exact di |
| 2026-05-23 | 3002808148-2026-17661 | Malfunction | Available | exact di |
| 2026-05-06 | 3002808148-2026-14594 | Malfunction | Available | exact di |
| 2026-05-05 | 3002808148-2026-14424 | Malfunction | Available | exact di |
| 2026-04-21 | 3002808148-2026-12384 | Malfunction | Available | exact di |
| 2026-04-17 | 3002808148-2026-12023 | Malfunction | Available | exact di |
| 2026-04-16 | 3002808148-2026-11684 | Malfunction | Available | exact di |
| 2026-04-15 | 3002808148-2026-11462 | Malfunction | Available | exact di |
| 2026-04-14 | 3002808148-2026-11279 | Malfunction | Available | exact di |
| 2026-04-07 | 3002808148-2026-10007 | Malfunction | Available | exact di |
| 2026-04-01 | 3002808148-2026-09242 | Malfunction | Available | exact di |
| 2026-03-31 | 3002808148-2026-08960 | Malfunction | Available | exact di |
| 2026-03-25 | 3002808148-2026-08058 | Malfunction | Available | exact di |
| 2026-03-09 | 3002808148-2026-06372 | Malfunction | Available | exact di |
| 2026-03-04 | 3002808148-2026-05978 | Malfunction | Available | exact di |
Showing the most recent 60 of 68 linked reports.
Showing 1–15 of 60
Regulatory clearances
Predicate lineage
K014166
Cited as predicate by: K110294
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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