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.

7,533 linked reportsMalfunction 7,472Injury 61
42841251672019-01: 0 reports for this device; peer average 3.06/device2019-02: 0 reports for this device; peer average 2.36/device2019-03: 0 reports for this device; peer average 3.94/device2019-04: 0 reports for this device; peer average 7.53/device2019-05: 0 reports for this device; peer average 3.29/device2019-06: 0 reports for this device; peer average 3.32/device2019-07: 0 reports for this device; peer average 4.44/device2019-08: 0 reports for this device; peer average 2.58/device2019-09: 0 reports for this device; peer average 2.56/device2019-10: 0 reports for this device; peer average 2.85/device2019-11: 0 reports for this device; peer average 2.95/device2019-12: 0 reports for this device; peer average 2.7/device2020-01: 0 reports for this device; peer average 2.3/device2020-02: 0 reports for this device; peer average 4.2/device2020-03: 0 reports for this device; peer average 2.8/device2020-04: 2 reports for this device; peer average 2.68/device2020-05: 0 reports for this device; peer average 5.11/device2020-06: 6 reports for this device; peer average 3.26/device2020-07: 16 reports for this device; peer average 6.28/device2020-08: 19 reports for this device; peer average 4.69/device2020-09: 41 reports for this device; peer average 4.72/device2020-10: 52 reports for this device; peer average 5.67/device2020-11: 44 reports for this device; peer average 5.97/device2020-12: 91 reports for this device; peer average 8.33/device2021-01: 96 reports for this device; peer average 8.44/device2021-02: 95 reports for this device; peer average 9.38/device2021-03: 114 reports for this device; peer average 10.53/device2021-04: 91 reports for this device; peer average 10.03/device2021-05: 97 reports for this device; peer average 9.13/device2021-06: 83 reports for this device; peer average 8.11/device2021-07: 87 reports for this device; peer average 8.45/device2021-08: 100 reports for this device; peer average 8.36/device2021-09: 122 reports for this device; peer average 10.86/device2021-10: 103 reports for this device; peer average 8.15/device2021-11: 82 reports for this device; peer average 9.29/device2021-12: 119 reports for this device; peer average 11.03/device2022-01: 111 reports for this device; peer average 9.56/device2022-02: 108 reports for this device; peer average 11.81/device2022-03: 135 reports for this device; peer average 12.61/device2022-04: 126 reports for this device; peer average 12.9/device2022-05: 142 reports for this device; peer average 12.29/device2022-06: 142 reports for this device; peer average 13.02/device2022-07: 132 reports for this device; peer average 11.78/device2022-08: 146 reports for this device; peer average 12/device2022-09: 126 reports for this device; peer average 11.45/device2022-10: 163 reports for this device; peer average 11.59/device2022-11: 124 reports for this device; peer average 11.06/device2022-12: 132 reports for this device; peer average 11.5/device2023-01: 117 reports for this device; peer average 10.1/device2023-02: 103 reports for this device; peer average 10.23/device2023-03: 147 reports for this device; peer average 13.6/device2023-04: 137 reports for this device; peer average 12.75/device2023-05: 136 reports for this device; peer average 11.31/device2023-06: 131 reports for this device; peer average 10.96/device2023-07: 123 reports for this device; peer average 11.85/device2023-08: 167 reports for this device; peer average 12.63/device2023-09: 127 reports for this device; peer average 11.39/device2023-10: 147 reports for this device; peer average 12.83/device2023-11: 143 reports for this device; peer average 13.26/device2023-12: 128 reports for this device; peer average 12.02/device2024-01: 119 reports for this device; peer average 12.3/device2024-02: 139 reports for this device; peer average 12.88/device2024-03: 146 reports for this device; peer average 15.23/device2024-04: 136 reports for this device; peer average 12.34/device2024-05: 105 reports for this device; peer average 11.03/device2024-06: 111 reports for this device; peer average 12.18/device2024-07: 102 reports for this device; peer average 12.83/device2024-08: 115 reports for this device; peer average 10.77/device2024-09: 144 reports for this device; peer average 11.07/device2024-10: 151 reports for this device; peer average 14.46/device2024-11: 44 reports for this device; peer average 8.14/device2024-12: 58 reports for this device; peer average 6.41/device2025-01: 76 reports for this device; peer average 7.24/device2025-02: 47 reports for this device; peer average 6.8/device2025-03: 92 reports for this device; peer average 8.09/device2025-04: 64 reports for this device; peer average 8.32/device2025-05: 56 reports for this device; peer average 9.01/device2025-06: 68 reports for this device; peer average 9.32/device2025-07: 68 reports for this device; peer average 8.89/device2025-08: 112 reports for this device; peer average 10.37/device2025-09: 50 reports for this device; peer average 7.08/device2025-10: 128 reports for this device; peer average 13.49/device2025-11: 97 reports for this device; peer average 21.81/device2025-12: 81 reports for this device; peer average 43.15/device2026-01: 94 reports for this device; peer average 33.27/device2026-02: 98 reports for this device; peer average 20.08/device2026-03: 104 reports for this device; peer average 18.96/device2026-04: 94 reports for this device; peer average 27.11/device2026-05: 122 reports for this device; peer average 28.33/device2026-06: 59 reports for this device; peer average 28.29/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0103.06
2019-0202.36
2019-0303.94
2019-0407.53
2019-0503.29
2019-0603.32
2019-0704.44
2019-0802.58
2019-0902.56
2019-1002.85
2019-1102.95
2019-1202.7
2020-0102.3
2020-0204.2
2020-0302.8
2020-0422.68
2020-0505.11
2020-0663.26
2020-07166.28
2020-08194.69
2020-09414.72
2020-10525.67
2020-11445.97
2020-12918.33
2021-01968.44
2021-02959.38
2021-0311410.53
2021-049110.03
2021-05979.13
2021-06838.11
2021-07878.45
2021-081008.36
2021-0912210.86
2021-101038.15
2021-11829.29
2021-1211911.03
2022-011119.56
2022-0210811.81
2022-0313512.61
2022-0412612.9
2022-0514212.29
2022-0614213.02
2022-0713211.78
2022-0814612
2022-0912611.45
2022-1016311.59
2022-1112411.06
2022-1213211.5
2023-0111710.1
2023-0210310.23
2023-0314713.6
2023-0413712.75
2023-0513611.31
2023-0613110.96
2023-0712311.85
2023-0816712.63
2023-0912711.39
2023-1014712.83
2023-1114313.26
2023-1212812.02
2024-0111912.3
2024-0213912.88
2024-0314615.23
2024-0413612.34
2024-0510511.03
2024-0611112.18
2024-0710212.83
2024-0811510.77
2024-0914411.07
2024-1015114.46
2024-11448.14
2024-12586.41
2025-01767.24
2025-02476.8
2025-03928.09
2025-04648.32
2025-05569.01
2025-06689.32
2025-07688.89
2025-0811210.37
2025-09507.08
2025-1012813.49
2025-119721.81
2025-128143.15
2026-019433.27
2026-029820.08
2026-0310418.96
2026-049427.11
2026-0512228.33
2026-065928.29
This device (reports/month)Average device in FDF, FDS, NWB (reports/device/month)
Failure-mode summaryAI-generated

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

Recall history
InitiatedRecall #ClassStatusReasonQuantityLink basis
2023-09-14Z-0056-2025Class IIOpen, ClassifiedCertain serial numbers of the CV-190 do not start up properly because parts that deviated from the specification were assembled into the power supply unit.Distribution: US Nationwide distribution.45 unitscode info di
Individual MAUDE reports
DateReport #TypeNarrativeLink basis
2026-06-303002808148-2026-22402MalfunctionAvailableexact di
2026-06-303002808148-2026-22401MalfunctionAvailableexact di
2026-06-293002808148-2026-22154MalfunctionAvailableexact di
2026-06-273002808148-2026-22095MalfunctionAvailableexact di
2026-06-273002808148-2026-22100MalfunctionAvailableexact di
2026-06-263002808148-2026-21987MalfunctionAvailableexact di
2026-06-253002808148-2026-21801MalfunctionAvailableexact di
2026-06-243002808148-2026-21596MalfunctionAvailableexact di
2026-06-243002808148-2026-21675MalfunctionAvailableexact di
2026-06-233002808148-2026-21414MalfunctionAvailableexact di
2026-06-233002808148-2026-21508MalfunctionAvailableexact di
2026-06-233002808148-2026-21496MalfunctionAvailableexact di
2026-06-233002808148-2026-21398MalfunctionAvailableexact di
2026-06-233002808148-2026-21410MalfunctionAvailableexact di
2026-06-233002808148-2026-21378MalfunctionAvailableexact di

Showing the most recent 200 of 7,533 linked reports.

Showing 1–15 of 200
Regulatory clearances

    Predicate lineage

    K131780

    Cited as predicate by: K192793, K222584, K222861, K231249, K232244, K250432

    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
    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.