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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.

51 linked reportsMalfunction 35Injury 13Death 3
257102019-01: 0 reports for this device; peer average 1.69/device2019-02: 0 reports for this device; peer average 3.17/device2019-03: 0 reports for this device; peer average 8.24/device2019-04: 0 reports for this device; peer average 4.93/device2019-05: 0 reports for this device; peer average 3.58/device2019-06: 0 reports for this device; peer average 4.13/device2019-07: 0 reports for this device; peer average 3.46/device2019-08: 0 reports for this device; peer average 4.29/device2019-09: 2 reports for this device; peer average 3.62/device2019-10: 0 reports for this device; peer average 3.65/device2019-11: 0 reports for this device; peer average 4/device2019-12: 0 reports for this device; peer average 4.41/device2020-01: 0 reports for this device; peer average 4.42/device2020-02: 0 reports for this device; peer average 3.64/device2020-03: 0 reports for this device; peer average 4.46/device2020-04: 0 reports for this device; peer average 3.95/device2020-05: 0 reports for this device; peer average 2.68/device2020-06: 0 reports for this device; peer average 5.32/device2020-07: 6 reports for this device; peer average 5/device2020-08: 2 reports for this device; peer average 3.79/device2020-09: 0 reports for this device; peer average 4.43/device2020-10: 2 reports for this device; peer average 4.07/device2020-11: 9 reports for this device; peer average 3.86/device2020-12: 5 reports for this device; peer average 5.38/device2021-01: 0 reports for this device; peer average 3.38/device2021-02: 6 reports for this device; peer average 4.09/device2021-03: 0 reports for this device; peer average 5.17/device2021-04: 0 reports for this device; peer average 3.69/device2021-05: 2 reports for this device; peer average 4.2/device2021-06: 0 reports for this device; peer average 5.35/device2021-07: 0 reports for this device; peer average 4.37/device2021-08: 0 reports for this device; peer average 4.07/device2021-09: 0 reports for this device; peer average 3.4/device2021-10: 0 reports for this device; peer average 2.62/device2021-11: 0 reports for this device; peer average 4.2/device2021-12: 6 reports for this device; peer average 3.1/device2022-01: 3 reports for this device; peer average 3.23/device2022-02: 0 reports for this device; peer average 3.12/device2022-03: 0 reports for this device; peer average 3.19/device2022-04: 0 reports for this device; peer average 3.41/device2022-05: 0 reports for this device; peer average 2.68/device2022-06: 0 reports for this device; peer average 4.21/device2022-07: 0 reports for this device; peer average 3/device2022-08: 4 reports for this device; peer average 4.21/device2022-09: 0 reports for this device; peer average 3.56/device2022-10: 0 reports for this device; peer average 3.26/device2022-11: 2 reports for this device; peer average 4.74/device2022-12: 0 reports for this device; peer average 4.26/device2023-01: 0 reports for this device; peer average 3.58/device2023-02: 0 reports for this device; peer average 3.65/device2023-03: 0 reports for this device; peer average 3.45/device2023-04: 0 reports for this device; peer average 4.71/device2023-05: 2 reports for this device; peer average 4.52/device2023-06: 0 reports for this device; peer average 3.91/device2023-07: 0 reports for this device; peer average 5.19/device2023-08: 0 reports for this device; peer average 3.08/device2023-09: 0 reports for this device; peer average 4.05/device2023-10: 0 reports for this device; peer average 3.11/device2023-11: 0 reports for this device; peer average 3.2/device2023-12: 0 reports for this device; peer average 3.5/device2024-01: 0 reports for this device; peer average 3.95/device2024-02: 0 reports for this device; peer average 4.11/device2024-03: 0 reports for this device; peer average 3.56/device2024-04: 0 reports for this device; peer average 4/device2024-05: 0 reports for this device; peer average 2.63/device2024-06: 0 reports for this device; peer average 3.5/device2024-07: 0 reports for this device; peer average 3.28/device2024-08: 0 reports for this device; peer average 3.17/device2024-09: 0 reports for this device; peer average 5.39/device2024-10: 0 reports for this device; peer average 3.38/device2024-11: 0 reports for this device; peer average 3.32/device2024-12: 0 reports for this device; peer average 4.15/device2025-01: 0 reports for this device; peer average 4/device2025-02: 0 reports for this device; peer average 7.82/device2025-03: 0 reports for this device; peer average 9.65/device2025-04: 0 reports for this device; peer average 2.83/device2025-05: 0 reports for this device; peer average 3.21/device2025-06: 0 reports for this device; peer average 3/device2025-07: 0 reports for this device; peer average 4.3/device2025-08: 0 reports for this device; peer average 3.48/device2025-09: 0 reports for this device; peer average 3.33/device2025-10: 0 reports for this device; peer average 4.67/device2025-11: 0 reports for this device; peer average 2.91/device2025-12: 0 reports for this device; peer average 2.64/device2026-01: 0 reports for this device; peer average 2.6/device2026-02: 0 reports for this device; peer average 2.94/device2026-03: 0 reports for this device; peer average 3.8/device2026-04: 0 reports for this device; peer average 3.86/device2026-05: 0 reports for this device; peer average 3/device2026-06: 0 reports for this device; peer average 1.85/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0101.69
2019-0203.17
2019-0308.24
2019-0404.93
2019-0503.58
2019-0604.13
2019-0703.46
2019-0804.29
2019-0923.62
2019-1003.65
2019-1104
2019-1204.41
2020-0104.42
2020-0203.64
2020-0304.46
2020-0403.95
2020-0502.68
2020-0605.32
2020-0765
2020-0823.79
2020-0904.43
2020-1024.07
2020-1193.86
2020-1255.38
2021-0103.38
2021-0264.09
2021-0305.17
2021-0403.69
2021-0524.2
2021-0605.35
2021-0704.37
2021-0804.07
2021-0903.4
2021-1002.62
2021-1104.2
2021-1263.1
2022-0133.23
2022-0203.12
2022-0303.19
2022-0403.41
2022-0502.68
2022-0604.21
2022-0703
2022-0844.21
2022-0903.56
2022-1003.26
2022-1124.74
2022-1204.26
2023-0103.58
2023-0203.65
2023-0303.45
2023-0404.71
2023-0524.52
2023-0603.91
2023-0705.19
2023-0803.08
2023-0904.05
2023-1003.11
2023-1103.2
2023-1203.5
2024-0103.95
2024-0204.11
2024-0303.56
2024-0404
2024-0502.63
2024-0603.5
2024-0703.28
2024-0803.17
2024-0905.39
2024-1003.38
2024-1103.32
2024-1204.15
2025-0104
2025-0207.82
2025-0309.65
2025-0402.83
2025-0503.21
2025-0603
2025-0704.3
2025-0803.48
2025-0903.33
2025-1004.67
2025-1102.91
2025-1202.64
2026-0102.6
2026-0202.94
2026-0303.8
2026-0403.86
2026-0503
2026-0601.85
This device (reports/month)Average device in HBC (reports/device/month)
Failure-mode summaryAI-generated

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

Recall history

No recalls linked.

Individual MAUDE reports
DateReport #TypeNarrativeLink basis
2023-05-269610612-2023-00124MalfunctionAvailablecatalog number
2022-11-239610612-2022-00350MalfunctionAvailablecatalog number
2022-08-259610612-2022-00207InjuryAvailablecatalog number
2022-08-159610612-2022-00246InjuryAvailablecatalog number
2022-01-109610612-2021-00809DeathAvailablecatalog number
2021-12-319610612-2021-00789MalfunctionAvailablecatalog number
2021-12-019610612-2021-00737InjuryAvailablecatalog number
2021-05-119610612-2021-00376MalfunctionAvailablecatalog number
2021-02-109610612-2021-00071InjuryAvailablecatalog number
2021-02-029610612-2021-00018MalfunctionAvailablecatalog number
2020-12-099610612-2020-00875MalfunctionAvailablecatalog number
2020-12-019610612-2020-00840MalfunctionAvailablecatalog number
2020-11-309610612-2020-00839InjuryAvailablecatalog number
2020-11-059610612-2020-00639MalfunctionAvailablecatalog number
2020-11-059610612-2020-00640MalfunctionAvailablecatalog number

Showing the most recent 22 of 51 linked reports.

Showing 1–15 of 22
Regulatory clearances

None linked.

Manufacturer compliance record
DateTypeOutcomeFacilityCitations
2025-07-11NAINo action indicatedAesculap Inc0
2025-07-11NAINo action indicatedAesculap Inc0
2022-07-21NAINo action indicatedAesculap AG0
2022-07-21NAINo action indicatedAesculap AG0
2021-08-11VAIVoluntary action indicatedAesculap Inc3
2021-08-11VAIVoluntary action indicatedAesculap Inc3
2018-06-13VAIVoluntary action indicatedAesculap Inc0
2018-06-13VAIVoluntary action indicatedAesculap Inc0
2016-09-22NAINo action indicatedAesculap AG0
2016-09-22NAINo action indicatedAesculap AG0
2016-09-14VAIVoluntary action indicatedAesculap Inc0
2016-09-14VAIVoluntary action indicatedAesculap Inc0
2016-07-13NAINo action indicatedAesculap Inc0
2016-07-13NAINo action indicatedAesculap Inc0
2015-07-16NAINo action indicatedAesculap AG1
2015-07-16NAINo action indicatedAesculap AG1
2015-05-05NAINo action indicatedAesculap Inc0
2015-05-05NAINo action indicatedAesculap Inc0
2014-10-23NAINo action indicatedAesculap Inc0
2014-10-23NAINo action indicatedAesculap Inc0
2011-09-26WLWarning LetterAesculap AG—
2011-09-26WLWarning LetterAesculap AG—
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