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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.

2 linked reportsMalfunction 2
13452019-01: 0 reports for this device; peer average 1.5/device2019-02: 2 reports for this device; peer average 5/device2019-03: 0 reports for this device; peer average 2/device2019-04: 0 reports for this device; peer average 1/device2019-05: 0 reports for this device; peer average 1/device2019-06: 0 reports for this device; peer average 1/device2019-07: 0 reports for this device; peer average 1/device2019-08: 0 reports for this device; peer average 1/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/device2020-03: 0 reports for this device; peer average 1/device2020-08: 0 reports for this device; peer average 1/device2020-09: 0 reports for this device; peer average 1/device2020-10: 0 reports for this device; peer average 1.5/device2020-11: 0 reports for this device; peer average 1.5/device2020-12: 0 reports for this device; peer average 2/device2021-01: 0 reports for this device; peer average 5/device2021-03: 0 reports for this device; peer average 1/device2021-05: 0 reports for this device; peer average 1/device2021-06: 0 reports for this device; peer average 2/device2021-07: 0 reports for this device; peer average 3/device2021-09: 0 reports for this device; peer average 1/device2021-10: 0 reports for this device; peer average 1/device2021-11: 0 reports for this device; peer average 3/device2021-12: 0 reports for this device; peer average 1/device2022-01: 0 reports for this device; peer average 1/device2022-02: 0 reports for this device; peer average 2/device2022-03: 0 reports for this device; peer average 2/device2022-04: 0 reports for this device; peer average 1/device2022-05: 0 reports for this device; peer average 1/device2022-06: 0 reports for this device; peer average 1/device2022-08: 0 reports for this device; peer average 1/device2022-11: 0 reports for this device; peer average 2/device2022-12: 0 reports for this device; peer average 1/device2023-03: 0 reports for this device; peer average 1/device2023-04: 0 reports for this device; peer average 2/device2023-05: 0 reports for this device; peer average 1/device2023-07: 0 reports for this device; peer average 1.5/device2023-08: 0 reports for this device; peer average 2/device2023-11: 0 reports for this device; peer average 2/device2023-12: 0 reports for this device; peer average 5/device2024-01: 0 reports for this device; peer average 1/device2024-02: 0 reports for this device; peer average 1/device2024-04: 0 reports for this device; peer average 1/device2024-05: 0 reports for this device; peer average 2/device2024-06: 0 reports for this device; peer average 1.5/device2024-07: 0 reports for this device; peer average 1/device2024-08: 0 reports for this device; peer average 1/device2024-09: 0 reports for this device; peer average 1/device2024-10: 0 reports for this device; peer average 2/device2024-11: 0 reports for this device; peer average 1/device2025-02: 0 reports for this device; peer average 1/device2025-03: 0 reports for this device; peer average 1/device2025-04: 0 reports for this device; peer average 1/device2025-05: 0 reports for this device; peer average 2/device2025-07: 0 reports for this device; peer average 1/device2025-08: 0 reports for this device; peer average 1/device2025-09: 0 reports for this device; peer average 1/device2025-12: 0 reports for this device; peer average 1/device2026-02: 0 reports for this device; peer average 1/device2026-04: 0 reports for this device; peer average 1/device0102030405060708101101030809101112010305060709101112010203040506081112030405070811120102040506070809101102030405070809120204
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0101.5
2019-0225
2019-0302
2019-0401
2019-0501
2019-0601
2019-0701
2019-0801
2019-1001
2019-1101
2020-0101
2020-0301
2020-0801
2020-0901
2020-1001.5
2020-1101.5
2020-1202
2021-0105
2021-0301
2021-0501
2021-0602
2021-0703
2021-0901
2021-1001
2021-1103
2021-1201
2022-0101
2022-0202
2022-0302
2022-0401
2022-0501
2022-0601
2022-0801
2022-1102
2022-1201
2023-0301
2023-0402
2023-0501
2023-0701.5
2023-0802
2023-1102
2023-1205
2024-0101
2024-0201
2024-0401
2024-0502
2024-0601.5
2024-0701
2024-0801
2024-0901
2024-1002
2024-1101
2025-0201
2025-0301
2025-0401
2025-0502
2025-0701
2025-0801
2025-0901
2025-1201
2026-0201
2026-0401
This device (reports/month)Average device in FZO (reports/device/month)
Failure-mode summaryAI-generated

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

Recall history

No recalls linked.

Individual MAUDE reports
DateReport #TypeNarrativeLink basis
2019-02-279610612-2019-00108MalfunctionAvailablecatalog number

Showing the most recent 1 of 2 linked reports.

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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