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.
48 linked reportsMalfunction 48
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 0 | 1.2 |
| 2019-02 | 0 | 1.5 |
| 2019-03 | 0 | 6.89 |
| 2019-04 | 0 | 44.75 |
| 2019-05 | 0 | 4 |
| 2019-06 | 0 | 3 |
| 2019-07 | 0 | 2.54 |
| 2019-08 | 0 | 4.78 |
| 2019-09 | 0 | 2.78 |
| 2019-10 | 0 | 2.57 |
| 2019-11 | 0 | 2.4 |
| 2019-12 | 0 | 4.25 |
| 2020-01 | 0 | 2.92 |
| 2020-02 | 0 | 6.2 |
| 2020-03 | 0 | 2.33 |
| 2020-04 | 0 | 4.31 |
| 2020-05 | 0 | 2.93 |
| 2020-06 | 0 | 4.24 |
| 2020-07 | 0 | 4.65 |
| 2020-08 | 0 | 4.5 |
| 2020-09 | 0 | 3.76 |
| 2020-10 | 0 | 3.91 |
| 2020-11 | 0 | 4.52 |
| 2020-12 | 0 | 6.57 |
| 2021-01 | 0 | 4.39 |
| 2021-02 | 0 | 4.04 |
| 2021-03 | 0 | 5.57 |
| 2021-04 | 0 | 4.75 |
| 2021-05 | 0 | 5.1 |
| 2021-06 | 0 | 4.02 |
| 2021-07 | 0 | 3.22 |
| 2021-08 | 0 | 4.9 |
| 2021-09 | 0 | 4.18 |
| 2021-10 | 0 | 4.75 |
| 2021-11 | 0 | 3.93 |
| 2021-12 | 0 | 4.87 |
| 2022-01 | 0 | 4.98 |
| 2022-02 | 1 | 4.54 |
| 2022-03 | 0 | 6.65 |
| 2022-04 | 0 | 6.56 |
| 2022-05 | 0 | 5.72 |
| 2022-06 | 0 | 6.05 |
| 2022-07 | 1 | 6.22 |
| 2022-08 | 1 | 5.78 |
| 2022-09 | 0 | 5.19 |
| 2022-10 | 1 | 5.56 |
| 2022-11 | 0 | 5.65 |
| 2022-12 | 0 | 5.77 |
| 2023-01 | 2 | 8 |
| 2023-02 | 1 | 5.67 |
| 2023-03 | 1 | 7.22 |
| 2023-04 | 3 | 5.99 |
| 2023-05 | 3 | 6.6 |
| 2023-06 | 1 | 6.31 |
| 2023-07 | 1 | 6.17 |
| 2023-08 | 1 | 7.54 |
| 2023-09 | 1 | 6.8 |
| 2023-10 | 0 | 6.71 |
| 2023-11 | 2 | 7.17 |
| 2023-12 | 1 | 7.04 |
| 2024-01 | 2 | 6.36 |
| 2024-02 | 1 | 6.05 |
| 2024-03 | 3 | 7.21 |
| 2024-04 | 4 | 6.19 |
| 2024-05 | 0 | 6.2 |
| 2024-06 | 1 | 7.13 |
| 2024-07 | 4 | 6.06 |
| 2024-08 | 0 | 7.7 |
| 2024-09 | 3 | 6.97 |
| 2024-10 | 3 | 8.15 |
| 2024-11 | 1 | 10.86 |
| 2024-12 | 1 | 4.17 |
| 2025-01 | 0 | 4.16 |
| 2025-02 | 0 | 3.73 |
| 2025-03 | 1 | 4.21 |
| 2025-04 | 0 | 4.31 |
| 2025-05 | 0 | 4.93 |
| 2025-06 | 0 | 4.86 |
| 2025-07 | 1 | 5.79 |
| 2025-08 | 0 | 5.13 |
| 2025-09 | 0 | 4.38 |
| 2025-10 | 0 | 5.19 |
| 2025-11 | 0 | 6.62 |
| 2025-12 | 0 | 10.31 |
| 2026-01 | 2 | 8.47 |
| 2026-02 | 0 | 6.48 |
| 2026-03 | 0 | 6.61 |
| 2026-04 | 0 | 8.85 |
| 2026-05 | 0 | 9.34 |
| 2026-06 | 0 | 8.3 |
Failure-mode summaryAI-generated
40 linked report narratives available — no AI summary generated yet.
Recall history
| Initiated | Recall # | Class | Status | Reason | Quantity | Link basis |
|---|---|---|---|---|---|---|
| 2023-09-25 | Z-0340-2024 | Class II | Open, Classified | Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the channel of the endoscopes has the potential for contamination that could lead to the risk of infectionDistribution: Worldwide - US Nationwide distribution. | 33 units | code info di |
| 2023-07-27 | Z-2499-2023 | Class II | Open, Classified | Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter being too large.Distribution: US Nationwide distribution. | 122 units | code info di |
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2026-01-12 | 9610595-2026-03367 | Malfunction | Available | exact di |
| 2026-01-12 | 9610595-2026-03352 | Malfunction | Available | exact di |
| 2025-07-08 | 9610595-2025-13331 | Malfunction | Available | exact di |
| 2025-03-07 | 9610595-2025-03323 | Malfunction | Available | exact di |
| 2024-12-11 | 9610595-2024-40476 | Malfunction | Available | exact di |
| 2024-11-11 | 9610595-2024-23136 | Malfunction | Available | exact di |
| 2024-10-21 | 9610595-2024-21447 | Malfunction | Available | exact di |
| 2024-10-08 | 9610595-2024-20397 | Malfunction | Available | exact di |
| 2024-10-02 | 9610595-2024-19924 | Malfunction | Available | exact di |
| 2024-09-30 | 9610595-2024-19510 | Malfunction | Available | exact di |
| 2024-09-26 | 9610595-2024-19350 | Malfunction | Available | exact di |
| 2024-09-23 | 9610595-2024-19001 | Malfunction | Available | exact di |
| 2024-07-24 | 9610595-2024-14773 | Malfunction | Available | exact di |
| 2024-07-17 | 9610595-2024-14280 | Malfunction | Available | exact di |
| 2024-07-08 | 9610595-2024-13537 | Malfunction | Available | exact di |
Showing 1–15 of 48
Regulatory clearances
- 510(k)K201300Substantially equivalent (SESE) · 2021-01-26clearance family
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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