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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.

20 linked reportsMalfunction 18Injury 2
369122019-01: 0 reports for this device; peer average 2.2/device2019-02: 0 reports for this device; peer average 5.33/device2019-03: 0 reports for this device; peer average 2.33/device2019-04: 0 reports for this device; peer average 1.67/device2019-05: 0 reports for this device; peer average 5/device2019-06: 0 reports for this device; peer average 2.5/device2019-07: 0 reports for this device; peer average 1.67/device2019-08: 0 reports for this device; peer average 2.33/device2019-09: 0 reports for this device; peer average 2.25/device2019-10: 0 reports for this device; peer average 1.73/device2019-11: 0 reports for this device; peer average 2/device2019-12: 0 reports for this device; peer average 1.67/device2020-01: 0 reports for this device; peer average 2.6/device2020-02: 0 reports for this device; peer average 1.33/device2020-03: 0 reports for this device; peer average 2/device2020-05: 0 reports for this device; peer average 4/device2020-06: 0 reports for this device; peer average 2.5/device2020-07: 0 reports for this device; peer average 3.8/device2020-08: 0 reports for this device; peer average 1.67/device2020-09: 0 reports for this device; peer average 2.33/device2020-10: 0 reports for this device; peer average 5/device2020-11: 0 reports for this device; peer average 6.33/device2020-12: 0 reports for this device; peer average 4.75/device2021-01: 0 reports for this device; peer average 1/device2021-02: 0 reports for this device; peer average 1.67/device2021-03: 0 reports for this device; peer average 4.13/device2021-04: 0 reports for this device; peer average 5.33/device2021-05: 0 reports for this device; peer average 3/device2021-06: 0 reports for this device; peer average 1.29/device2021-07: 0 reports for this device; peer average 12/device2021-08: 0 reports for this device; peer average 2.67/device2021-09: 0 reports for this device; peer average 5/device2021-10: 0 reports for this device; peer average 2.25/device2021-11: 0 reports for this device; peer average 4.33/device2021-12: 0 reports for this device; peer average 1.75/device2022-01: 0 reports for this device; peer average 2/device2022-02: 0 reports for this device; peer average 1.67/device2022-03: 0 reports for this device; peer average 6.43/device2022-04: 0 reports for this device; peer average 3.67/device2022-05: 0 reports for this device; peer average 4.67/device2022-06: 0 reports for this device; peer average 2.17/device2022-07: 0 reports for this device; peer average 2.8/device2022-08: 0 reports for this device; peer average 10.5/device2022-09: 0 reports for this device; peer average 6.67/device2022-10: 0 reports for this device; peer average 2.4/device2022-11: 0 reports for this device; peer average 2.33/device2022-12: 0 reports for this device; peer average 2.33/device2023-01: 0 reports for this device; peer average 3/device2023-02: 0 reports for this device; peer average 2.43/device2023-03: 0 reports for this device; peer average 2.5/device2023-04: 0 reports for this device; peer average 2/device2023-05: 0 reports for this device; peer average 7.5/device2023-06: 0 reports for this device; peer average 3.5/device2023-07: 0 reports for this device; peer average 6.6/device2023-08: 0 reports for this device; peer average 2.25/device2023-09: 0 reports for this device; peer average 3/device2023-10: 0 reports for this device; peer average 5.8/device2023-11: 0 reports for this device; peer average 4.33/device2023-12: 0 reports for this device; peer average 5.2/device2024-01: 0 reports for this device; peer average 1.89/device2024-02: 0 reports for this device; peer average 3.57/device2024-03: 0 reports for this device; peer average 2.5/device2024-04: 0 reports for this device; peer average 3.29/device2024-05: 0 reports for this device; peer average 3.8/device2024-06: 0 reports for this device; peer average 3/device2024-07: 2 reports for this device; peer average 2.07/device2024-08: 0 reports for this device; peer average 2.86/device2024-09: 4 reports for this device; peer average 4.5/device2024-10: 1 reports for this device; peer average 3.33/device2024-11: 3 reports for this device; peer average 2.71/device2024-12: 2 reports for this device; peer average 2.5/device2025-01: 0 reports for this device; peer average 3.33/device2025-02: 0 reports for this device; peer average 4.14/device2025-03: 1 reports for this device; peer average 2.2/device2025-04: 0 reports for this device; peer average 6/device2025-05: 3 reports for this device; peer average 2.67/device2025-06: 0 reports for this device; peer average 4.14/device2025-07: 0 reports for this device; peer average 2/device2025-08: 1 reports for this device; peer average 3.88/device2025-09: 0 reports for this device; peer average 2.67/device2025-10: 3 reports for this device; peer average 6.75/device2025-11: 0 reports for this device; peer average 2.25/device2025-12: 0 reports for this device; peer average 4.5/device2026-01: 0 reports for this device; peer average 2.5/device2026-02: 0 reports for this device; peer average 2.11/device2026-03: 0 reports for this device; peer average 2.75/device2026-04: 0 reports for this device; peer average 3.5/device2026-05: 0 reports for this device; peer average 2.56/device2026-06: 0 reports for this device; peer average 4.86/device0102030405060708091011120102030506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0102.2
2019-0205.33
2019-0302.33
2019-0401.67
2019-0505
2019-0602.5
2019-0701.67
2019-0802.33
2019-0902.25
2019-1001.73
2019-1102
2019-1201.67
2020-0102.6
2020-0201.33
2020-0302
2020-0504
2020-0602.5
2020-0703.8
2020-0801.67
2020-0902.33
2020-1005
2020-1106.33
2020-1204.75
2021-0101
2021-0201.67
2021-0304.13
2021-0405.33
2021-0503
2021-0601.29
2021-07012
2021-0802.67
2021-0905
2021-1002.25
2021-1104.33
2021-1201.75
2022-0102
2022-0201.67
2022-0306.43
2022-0403.67
2022-0504.67
2022-0602.17
2022-0702.8
2022-08010.5
2022-0906.67
2022-1002.4
2022-1102.33
2022-1202.33
2023-0103
2023-0202.43
2023-0302.5
2023-0402
2023-0507.5
2023-0603.5
2023-0706.6
2023-0802.25
2023-0903
2023-1005.8
2023-1104.33
2023-1205.2
2024-0101.89
2024-0203.57
2024-0302.5
2024-0403.29
2024-0503.8
2024-0603
2024-0722.07
2024-0802.86
2024-0944.5
2024-1013.33
2024-1132.71
2024-1222.5
2025-0103.33
2025-0204.14
2025-0312.2
2025-0406
2025-0532.67
2025-0604.14
2025-0702
2025-0813.88
2025-0902.67
2025-1036.75
2025-1102.25
2025-1204.5
2026-0102.5
2026-0202.11
2026-0302.75
2026-0403.5
2026-0502.56
2026-0604.86
This device (reports/month)Average device in JOL (reports/device/month)
Failure-mode summaryAI-generated

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

Recall history

No recalls linked.

Individual MAUDE reports
DateReport #TypeNarrativeLink basis
2025-10-161527821-2025-00024MalfunctionAvailablecatalog number
2025-08-14MW5174574MalfunctionAvailablemodel number
2025-05-021527821-2025-00006MalfunctionAvailablecatalog number
2025-03-21MW5167953MalfunctionAvailablemodel number
2024-12-181527821-2024-00016MalfunctionAvailablecatalog number
2024-11-151527821-2024-00020MalfunctionAvailablecatalog number
2024-10-16MW5161165InjuryAvailablemodel number
2024-09-26MW5160245InjuryAvailablemodel number
2024-09-051527821-2024-00012MalfunctionAvailablecatalog number
2024-07-121527821-2024-00005MalfunctionAvailableexact di

Showing the most recent 10 of 20 linked reports.

Regulatory clearances

None linked.

Manufacturer compliance record
DateTypeOutcomeFacilityCitations
2026-04-16NAINo action indicatedSteris Corporation0
2026-04-16NAINo action indicatedSteris Corporation0
2026-04-03NAINo action indicatedIsomedix Operations Inc.0
2026-03-12NAINo action indicatedIsomedix Operations Inc0
2026-02-26VAIVoluntary action indicatedSteris S.p.A.1
2026-02-12VAIVoluntary action indicatedSynergy Health Ede BV2
2026-02-12NAINo action indicatedSynergy Health Marseille0
2025-12-12OAIOfficial action indicatedBlack Diamond Video Inc.3
2025-08-01VAIVoluntary action indicatedSTERIS Laboratories, Inc.2
2025-06-18NAINo action indicatedIsomedix Operations Inc.0
2025-06-17NAINo action indicatedIsomedix Operations Inc0
2025-06-05NAINo action indicatedIsomedix Operations, Inc.0
2025-04-01NAINo action indicatedSteris Corporation0
2025-02-21NAINo action indicatedIsomedix Operations Inc.0
2025-01-23NAINo action indicatedSynergy Health Allershausen GmbH0
2024-12-12VAIVoluntary action indicatedIsomedix Operations, Inc0
2024-12-05NAINo action indicatedSteris (Synergy Health Ede BV)0
2024-11-21VAIVoluntary action indicatedSteris Applied Sterilization Technologies ULC2
2024-09-23NAINo action indicatedIsomedix Operations, Inc.0
2024-09-19NAINo action indicatedIsomedix Operations, Inc.0
2015-02-20WLWarning LetterKey Surgical LLC—
2014-05-22WLWarning LetterIsomedix Operations, Inc.—
2012-05-29WLWarning LetterAlbert Browne Ltd.—
2011-02-09WLWarning LetterSteris Corporation—
2011-02-09WLWarning LetterSteris Corporation—
2010-09-27WLWarning LetterIsomedix Operations, Inc.—
2010-04-20INJInjunctionSteris Corporation—
2010-04-20INJInjunctionSteris Corporation—
2009-07-31WLWarning LetterMedivators Inc—
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