Skip to content
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.

16 linked reportsInjury 10Malfunction 6
214263842019-01: 0 reports for this device; peer average 1/device2019-02: 0 reports for this device; peer average 1/device2019-04: 0 reports for this device; peer average 4/device2019-05: 0 reports for this device; peer average 1/device2019-06: 0 reports for this device; peer average 1/device2019-08: 1 reports for this device; peer average 1.67/device2019-09: 0 reports for this device; peer average 5/device2019-10: 0 reports for this device; peer average 1/device2019-11: 0 reports for this device; peer average 1/device2020-01: 0 reports for this device; peer average 1/device2020-02: 6 reports for this device; peer average 2.67/device2020-03: 0 reports for this device; peer average 4.5/device2020-04: 0 reports for this device; peer average 6.67/device2020-05: 0 reports for this device; peer average 7/device2020-06: 0 reports for this device; peer average 11.5/device2020-07: 0 reports for this device; peer average 24/device2020-08: 0 reports for this device; peer average 16/device2020-09: 0 reports for this device; peer average 23.5/device2020-10: 2 reports for this device; peer average 14.25/device2020-11: 0 reports for this device; peer average 37/device2020-12: 0 reports for this device; peer average 40/device2021-01: 0 reports for this device; peer average 23/device2021-02: 0 reports for this device; peer average 16.25/device2021-03: 0 reports for this device; peer average 24/device2021-04: 0 reports for this device; peer average 28.67/device2021-05: 1 reports for this device; peer average 16.75/device2021-06: 0 reports for this device; peer average 23.5/device2021-07: 0 reports for this device; peer average 23.67/device2021-08: 0 reports for this device; peer average 42.5/device2021-09: 0 reports for this device; peer average 37/device2021-10: 0 reports for this device; peer average 34.5/device2021-11: 0 reports for this device; peer average 58.5/device2021-12: 0 reports for this device; peer average 38/device2022-01: 0 reports for this device; peer average 44.67/device2022-02: 0 reports for this device; peer average 48/device2022-03: 0 reports for this device; peer average 31.5/device2022-04: 0 reports for this device; peer average 32.5/device2022-05: 0 reports for this device; peer average 54.5/device2022-06: 0 reports for this device; peer average 22.2/device2022-07: 2 reports for this device; peer average 30/device2022-08: 0 reports for this device; peer average 61/device2022-09: 0 reports for this device; peer average 24.5/device2022-10: 0 reports for this device; peer average 15.33/device2022-11: 0 reports for this device; peer average 50/device2022-12: 0 reports for this device; peer average 13.33/device2023-01: 0 reports for this device; peer average 21.5/device2023-02: 0 reports for this device; peer average 43/device2023-03: 0 reports for this device; peer average 31.67/device2023-04: 0 reports for this device; peer average 22.5/device2023-05: 0 reports for this device; peer average 14.33/device2023-06: 0 reports for this device; peer average 66/device2023-07: 0 reports for this device; peer average 16/device2023-08: 0 reports for this device; peer average 22/device2023-09: 0 reports for this device; peer average 21.33/device2023-10: 0 reports for this device; peer average 27/device2023-11: 0 reports for this device; peer average 28.33/device2023-12: 0 reports for this device; peer average 27/device2024-01: 0 reports for this device; peer average 42.5/device2024-02: 0 reports for this device; peer average 49/device2024-03: 0 reports for this device; peer average 35.5/device2024-04: 0 reports for this device; peer average 19/device2024-05: 0 reports for this device; peer average 22.67/device2024-06: 0 reports for this device; peer average 31/device2024-07: 0 reports for this device; peer average 37.5/device2024-08: 0 reports for this device; peer average 84/device2024-09: 1 reports for this device; peer average 64/device2024-10: 0 reports for this device; peer average 41.25/device2024-11: 2 reports for this device; peer average 23.75/device2024-12: 0 reports for this device; peer average 17/device2025-01: 0 reports for this device; peer average 8/device2025-02: 0 reports for this device; peer average 6/device2025-03: 0 reports for this device; peer average 5.33/device2025-04: 0 reports for this device; peer average 3.25/device2025-05: 0 reports for this device; peer average 2.8/device2025-06: 0 reports for this device; peer average 4.6/device2025-07: 0 reports for this device; peer average 3.33/device2025-08: 0 reports for this device; peer average 7.4/device2025-09: 0 reports for this device; peer average 6.33/device2025-10: 0 reports for this device; peer average 15/device2025-11: 0 reports for this device; peer average 7.75/device2025-12: 0 reports for this device; peer average 5.33/device2026-01: 0 reports for this device; peer average 2.5/device2026-02: 1 reports for this device; peer average 3.83/device2026-03: 0 reports for this device; peer average 8/device2026-04: 0 reports for this device; peer average 4/device2026-05: 0 reports for this device; peer average 3.5/device2026-06: 0 reports for this device; peer average 4.33/device010204050608091011010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0101
2019-0201
2019-0404
2019-0501
2019-0601
2019-0811.67
2019-0905
2019-1001
2019-1101
2020-0101
2020-0262.67
2020-0304.5
2020-0406.67
2020-0507
2020-06011.5
2020-07024
2020-08016
2020-09023.5
2020-10214.25
2020-11037
2020-12040
2021-01023
2021-02016.25
2021-03024
2021-04028.67
2021-05116.75
2021-06023.5
2021-07023.67
2021-08042.5
2021-09037
2021-10034.5
2021-11058.5
2021-12038
2022-01044.67
2022-02048
2022-03031.5
2022-04032.5
2022-05054.5
2022-06022.2
2022-07230
2022-08061
2022-09024.5
2022-10015.33
2022-11050
2022-12013.33
2023-01021.5
2023-02043
2023-03031.67
2023-04022.5
2023-05014.33
2023-06066
2023-07016
2023-08022
2023-09021.33
2023-10027
2023-11028.33
2023-12027
2024-01042.5
2024-02049
2024-03035.5
2024-04019
2024-05022.67
2024-06031
2024-07037.5
2024-08084
2024-09164
2024-10041.25
2024-11223.75
2024-12017
2025-0108
2025-0206
2025-0305.33
2025-0403.25
2025-0502.8
2025-0604.6
2025-0703.33
2025-0807.4
2025-0906.33
2025-10015
2025-1107.75
2025-1205.33
2026-0102.5
2026-0213.83
2026-0308
2026-0404
2026-0503.5
2026-0604.33
This device (reports/month)Average device in FCX (reports/device/month)
Failure-mode summaryAI-generated

16 linked report narratives available — no AI summary generated yet.

Recall history

No recalls linked.

Individual MAUDE reports
DateReport #TypeNarrativeLink basis
2026-02-113002808148-2026-03902MalfunctionAvailableexact di
2024-11-223002808148-2024-11125InjuryAvailableexact di
2024-11-222429304-2024-0000470InjuryAvailableexact di
2024-09-113002808148-2024-08625MalfunctionAvailableexact di
2022-07-058010047-2022-11288MalfunctionAvailableexact di
2022-07-058010047-2022-11287MalfunctionAvailableexact di
2021-05-078010047-2021-05984MalfunctionAvailableexact di
2020-10-158010047-2020-07726MalfunctionAvailableexact di
2020-10-048010047-2020-07187InjuryAvailableexact di
2020-02-278010047-2020-01525InjuryAvailableexact di
2020-02-278010047-2020-01527InjuryAvailableexact di
2020-02-278010047-2020-01528InjuryAvailableexact di
2020-02-278010047-2020-01526InjuryAvailableexact di
2020-02-278010047-2020-01523InjuryAvailableexact di
2020-02-278010047-2020-01524InjuryAvailableexact di
Showing 1–15 of 16
Regulatory clearances

None linked.

Manufacturer compliance record
DateTypeOutcomeFacilityCitations
2022-12-12WLWarning LetterOlympus Medical Systems Corporation—
2022-09-09OAIOfficial action indicatedOlympus Medical Systems Corporation1
2018-03-09WLWarning LetterOlympus Medical Systems Corporation—
2015-04-24OAIOfficial action indicatedOlympus Medical Systems Corporation2
Similar devices
Select up to two to place side-by-side with this device.