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.

18 linked reportsMalfunction 16Death 2
102030402019-01: 0 reports for this device; peer average 4/device2019-02: 0 reports for this device; peer average 2.86/device2019-03: 0 reports for this device; peer average 4.21/device2019-04: 2 reports for this device; peer average 6.72/device2019-05: 0 reports for this device; peer average 3.91/device2019-06: 0 reports for this device; peer average 3.3/device2019-07: 0 reports for this device; peer average 5.61/device2019-08: 0 reports for this device; peer average 2.73/device2019-09: 0 reports for this device; peer average 2.63/device2019-10: 0 reports for this device; peer average 2.93/device2019-11: 0 reports for this device; peer average 3.76/device2019-12: 0 reports for this device; peer average 3.19/device2020-01: 0 reports for this device; peer average 2.61/device2020-02: 0 reports for this device; peer average 4.5/device2020-03: 0 reports for this device; peer average 3.17/device2020-04: 0 reports for this device; peer average 2.83/device2020-05: 0 reports for this device; peer average 5.2/device2020-06: 2 reports for this device; peer average 3.57/device2020-07: 0 reports for this device; peer average 7.61/device2020-08: 0 reports for this device; peer average 5.23/device2020-09: 0 reports for this device; peer average 5.43/device2020-10: 0 reports for this device; peer average 6.32/device2020-11: 0 reports for this device; peer average 6.38/device2020-12: 0 reports for this device; peer average 8.66/device2021-01: 0 reports for this device; peer average 8.6/device2021-02: 0 reports for this device; peer average 9.19/device2021-03: 0 reports for this device; peer average 11.2/device2021-04: 0 reports for this device; peer average 10.29/device2021-05: 0 reports for this device; peer average 9.29/device2021-06: 2 reports for this device; peer average 8.09/device2021-07: 0 reports for this device; peer average 8.62/device2021-08: 0 reports for this device; peer average 8.75/device2021-09: 0 reports for this device; peer average 12/device2021-10: 0 reports for this device; peer average 8.69/device2021-11: 0 reports for this device; peer average 9.94/device2021-12: 0 reports for this device; peer average 12.07/device2022-01: 2 reports for this device; peer average 9.73/device2022-02: 0 reports for this device; peer average 12.16/device2022-03: 0 reports for this device; peer average 13.2/device2022-04: 0 reports for this device; peer average 13.5/device2022-05: 0 reports for this device; peer average 12.94/device2022-06: 0 reports for this device; peer average 13.66/device2022-07: 0 reports for this device; peer average 11.74/device2022-08: 2 reports for this device; peer average 11.86/device2022-09: 0 reports for this device; peer average 11.65/device2022-10: 0 reports for this device; peer average 11.84/device2022-11: 1 reports for this device; peer average 10.69/device2022-12: 2 reports for this device; peer average 11.53/device2023-01: 0 reports for this device; peer average 10.33/device2023-02: 0 reports for this device; peer average 10.62/device2023-03: 0 reports for this device; peer average 13.57/device2023-04: 0 reports for this device; peer average 12.86/device2023-05: 0 reports for this device; peer average 11.57/device2023-06: 1 reports for this device; peer average 11.03/device2023-07: 0 reports for this device; peer average 11.8/device2023-08: 0 reports for this device; peer average 12.95/device2023-09: 1 reports for this device; peer average 11.73/device2023-10: 0 reports for this device; peer average 13.29/device2023-11: 0 reports for this device; peer average 13.37/device2023-12: 1 reports for this device; peer average 12.32/device2024-01: 0 reports for this device; peer average 13.25/device2024-02: 0 reports for this device; peer average 13.7/device2024-03: 0 reports for this device; peer average 16/device2024-04: 0 reports for this device; peer average 13.12/device2024-05: 0 reports for this device; peer average 12.18/device2024-06: 0 reports for this device; peer average 13.61/device2024-07: 0 reports for this device; peer average 13.86/device2024-08: 0 reports for this device; peer average 11.6/device2024-09: 0 reports for this device; peer average 12.09/device2024-10: 0 reports for this device; peer average 15.65/device2024-11: 0 reports for this device; peer average 8.67/device2024-12: 0 reports for this device; peer average 7.26/device2025-01: 0 reports for this device; peer average 7.94/device2025-02: 0 reports for this device; peer average 6.75/device2025-03: 0 reports for this device; peer average 8.21/device2025-04: 0 reports for this device; peer average 8.5/device2025-05: 0 reports for this device; peer average 8.79/device2025-06: 0 reports for this device; peer average 9.18/device2025-07: 0 reports for this device; peer average 8.85/device2025-08: 0 reports for this device; peer average 10.5/device2025-09: 0 reports for this device; peer average 7.14/device2025-10: 0 reports for this device; peer average 12.94/device2025-11: 1 reports for this device; peer average 20.16/device2025-12: 0 reports for this device; peer average 39.56/device2026-01: 0 reports for this device; peer average 31.61/device2026-02: 1 reports for this device; peer average 18.46/device2026-03: 0 reports for this device; peer average 18.15/device2026-04: 0 reports for this device; peer average 26.31/device2026-05: 0 reports for this device; peer average 27.58/device2026-06: 0 reports for this device; peer average 26.71/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0104
2019-0202.86
2019-0304.21
2019-0426.72
2019-0503.91
2019-0603.3
2019-0705.61
2019-0802.73
2019-0902.63
2019-1002.93
2019-1103.76
2019-1203.19
2020-0102.61
2020-0204.5
2020-0303.17
2020-0402.83
2020-0505.2
2020-0623.57
2020-0707.61
2020-0805.23
2020-0905.43
2020-1006.32
2020-1106.38
2020-1208.66
2021-0108.6
2021-0209.19
2021-03011.2
2021-04010.29
2021-0509.29
2021-0628.09
2021-0708.62
2021-0808.75
2021-09012
2021-1008.69
2021-1109.94
2021-12012.07
2022-0129.73
2022-02012.16
2022-03013.2
2022-04013.5
2022-05012.94
2022-06013.66
2022-07011.74
2022-08211.86
2022-09011.65
2022-10011.84
2022-11110.69
2022-12211.53
2023-01010.33
2023-02010.62
2023-03013.57
2023-04012.86
2023-05011.57
2023-06111.03
2023-07011.8
2023-08012.95
2023-09111.73
2023-10013.29
2023-11013.37
2023-12112.32
2024-01013.25
2024-02013.7
2024-03016
2024-04013.12
2024-05012.18
2024-06013.61
2024-07013.86
2024-08011.6
2024-09012.09
2024-10015.65
2024-1108.67
2024-1207.26
2025-0107.94
2025-0206.75
2025-0308.21
2025-0408.5
2025-0508.79
2025-0609.18
2025-0708.85
2025-08010.5
2025-0907.14
2025-10012.94
2025-11120.16
2025-12039.56
2026-01031.61
2026-02118.46
2026-03018.15
2026-04026.31
2026-05027.58
2026-06026.71
This device (reports/month)Average device in FDF, FDS, FDT, FET, NWB (reports/device/month)
Failure-mode summaryAI-generated

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

Recall history

No recalls linked.

Individual MAUDE reports
DateReport #TypeNarrativeLink basis
2026-02-119610595-2026-13927MalfunctionAvailableexact di
2025-11-219610595-2025-33907MalfunctionAvailableexact di
2023-12-119610595-2023-19194MalfunctionAvailableexact di
2023-09-149610595-2023-13335MalfunctionAvailableexact di
2023-06-029610595-2023-08328MalfunctionAvailableexact di
2022-12-219610595-2022-05931MalfunctionAvailableexact di
2022-12-099610595-2022-05181MalfunctionAvailableexact di
2022-11-049610595-2022-03616MalfunctionAvailableexact di
2022-08-259610595-2022-01280MalfunctionAvailableexact di
2022-08-019610595-2022-00477MalfunctionAvailableexact di
2022-01-248010047-2022-01849MalfunctionAvailableexact di
2021-06-098010047-2021-07300MalfunctionAvailableexact di
2020-06-018010047-2020-03017DeathAvailableexact di
2019-04-028010047-2019-01471MalfunctionAvailableexact di

Showing the most recent 14 of 18 linked reports.

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.