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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.

868 linked reportsMalfunction 632Injury 235Death 1
102131412019-01: 13 reports for this device; peer average 4.33/device2019-02: 15 reports for this device; peer average 5.22/device2019-03: 25 reports for this device; peer average 5.13/device2019-04: 17 reports for this device; peer average 5.93/device2019-05: 17 reports for this device; peer average 5.62/device2019-06: 13 reports for this device; peer average 4.83/device2019-07: 23 reports for this device; peer average 5.82/device2019-08: 10 reports for this device; peer average 3.1/device2019-09: 11 reports for this device; peer average 3.7/device2019-10: 8 reports for this device; peer average 4.36/device2019-11: 9 reports for this device; peer average 3.78/device2019-12: 17 reports for this device; peer average 5.45/device2020-01: 8 reports for this device; peer average 4.56/device2020-02: 4 reports for this device; peer average 2.78/device2020-03: 15 reports for this device; peer average 4.5/device2020-04: 6 reports for this device; peer average 3.1/device2020-05: 1 reports for this device; peer average 2/device2020-06: 6 reports for this device; peer average 2.44/device2020-07: 12 reports for this device; peer average 3.77/device2020-08: 6 reports for this device; peer average 2.3/device2020-09: 9 reports for this device; peer average 4.22/device2020-10: 21 reports for this device; peer average 4.55/device2020-11: 10 reports for this device; peer average 4.6/device2020-12: 8 reports for this device; peer average 3.54/device2021-01: 11 reports for this device; peer average 3.67/device2021-02: 5 reports for this device; peer average 3.25/device2021-03: 13 reports for this device; peer average 4/device2021-04: 10 reports for this device; peer average 3.77/device2021-05: 10 reports for this device; peer average 2.92/device2021-06: 22 reports for this device; peer average 4.33/device2021-07: 11 reports for this device; peer average 2.92/device2021-08: 8 reports for this device; peer average 4.17/device2021-09: 15 reports for this device; peer average 3.43/device2021-10: 9 reports for this device; peer average 2.91/device2021-11: 5 reports for this device; peer average 3.36/device2021-12: 9 reports for this device; peer average 3.75/device2022-01: 6 reports for this device; peer average 4/device2022-02: 9 reports for this device; peer average 4.33/device2022-03: 6 reports for this device; peer average 3.4/device2022-04: 15 reports for this device; peer average 3.27/device2022-05: 22 reports for this device; peer average 6.4/device2022-06: 41 reports for this device; peer average 6.67/device2022-07: 18 reports for this device; peer average 5/device2022-08: 22 reports for this device; peer average 4.67/device2022-09: 17 reports for this device; peer average 2.93/device2022-10: 11 reports for this device; peer average 3.82/device2022-11: 5 reports for this device; peer average 3.18/device2022-12: 7 reports for this device; peer average 2.83/device2023-01: 9 reports for this device; peer average 3.67/device2023-02: 7 reports for this device; peer average 3.5/device2023-03: 8 reports for this device; peer average 3.69/device2023-04: 5 reports for this device; peer average 3.55/device2023-05: 11 reports for this device; peer average 3.39/device2023-06: 4 reports for this device; peer average 2.68/device2023-07: 14 reports for this device; peer average 3.75/device2023-08: 8 reports for this device; peer average 3.25/device2023-09: 7 reports for this device; peer average 3.07/device2023-10: 8 reports for this device; peer average 5.38/device2023-11: 7 reports for this device; peer average 3.22/device2023-12: 5 reports for this device; peer average 4.73/device2024-01: 8 reports for this device; peer average 4.55/device2024-02: 13 reports for this device; peer average 3.22/device2024-03: 8 reports for this device; peer average 2.73/device2024-04: 2 reports for this device; peer average 3.75/device2024-05: 2 reports for this device; peer average 2.14/device2024-06: 9 reports for this device; peer average 3.54/device2024-07: 2 reports for this device; peer average 2.58/device2024-08: 7 reports for this device; peer average 2.71/device2024-09: 8 reports for this device; peer average 3.21/device2024-10: 5 reports for this device; peer average 3.6/device2024-11: 2 reports for this device; peer average 3.43/device2024-12: 3 reports for this device; peer average 1.8/device2025-01: 17 reports for this device; peer average 5/device2025-02: 4 reports for this device; peer average 4.15/device2025-03: 8 reports for this device; peer average 4.33/device2025-04: 7 reports for this device; peer average 4.22/device2025-05: 5 reports for this device; peer average 4.45/device2025-06: 13 reports for this device; peer average 4.65/device2025-07: 7 reports for this device; peer average 5.56/device2025-08: 10 reports for this device; peer average 4.33/device2025-09: 2 reports for this device; peer average 2.5/device2025-10: 4 reports for this device; peer average 3.13/device2025-11: 5 reports for this device; peer average 4.64/device2025-12: 5 reports for this device; peer average 6.5/device2026-01: 0 reports for this device; peer average 4.29/device2026-02: 7 reports for this device; peer average 4.42/device2026-03: 8 reports for this device; peer average 5.57/device2026-04: 4 reports for this device; peer average 7.07/device2026-05: 3 reports for this device; peer average 11.14/device2026-06: 6 reports for this device; peer average 7.69/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-01134.33
2019-02155.22
2019-03255.13
2019-04175.93
2019-05175.62
2019-06134.83
2019-07235.82
2019-08103.1
2019-09113.7
2019-1084.36
2019-1193.78
2019-12175.45
2020-0184.56
2020-0242.78
2020-03154.5
2020-0463.1
2020-0512
2020-0662.44
2020-07123.77
2020-0862.3
2020-0994.22
2020-10214.55
2020-11104.6
2020-1283.54
2021-01113.67
2021-0253.25
2021-03134
2021-04103.77
2021-05102.92
2021-06224.33
2021-07112.92
2021-0884.17
2021-09153.43
2021-1092.91
2021-1153.36
2021-1293.75
2022-0164
2022-0294.33
2022-0363.4
2022-04153.27
2022-05226.4
2022-06416.67
2022-07185
2022-08224.67
2022-09172.93
2022-10113.82
2022-1153.18
2022-1272.83
2023-0193.67
2023-0273.5
2023-0383.69
2023-0453.55
2023-05113.39
2023-0642.68
2023-07143.75
2023-0883.25
2023-0973.07
2023-1085.38
2023-1173.22
2023-1254.73
2024-0184.55
2024-02133.22
2024-0382.73
2024-0423.75
2024-0522.14
2024-0693.54
2024-0722.58
2024-0872.71
2024-0983.21
2024-1053.6
2024-1123.43
2024-1231.8
2025-01175
2025-0244.15
2025-0384.33
2025-0474.22
2025-0554.45
2025-06134.65
2025-0775.56
2025-08104.33
2025-0922.5
2025-1043.13
2025-1154.64
2025-1256.5
2026-0104.29
2026-0274.42
2026-0385.57
2026-0447.07
2026-05311.14
2026-0667.69
This device (reports/month)Average device in OCW (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
2026-06-309612501-2026-01772InjuryAvailableexact di
2026-06-259612501-2026-01737InjuryAvailableexact di
2026-06-249612501-2026-01715InjuryAvailableexact di
2026-06-199612501-2026-01675InjuryAvailableexact di
2026-06-0525408140MalfunctionAvailableexact di
2026-05-289612501-2026-01469MalfunctionAvailableexact di
2026-05-0725111022MalfunctionAvailablemodel number
2026-05-039612501-2026-01228MalfunctionAvailableexact di
2026-04-309612501-2026-01212InjuryAvailableexact di
2026-04-229612501-2026-01134InjuryAvailableexact di
2026-04-149612501-2026-01073InjuryAvailableexact di
2026-04-099612501-2026-01038MalfunctionAvailableexact di
2026-03-259612501-2026-00882MalfunctionAvailableexact di
2026-03-199612501-2026-00806InjuryAvailableexact di
2026-03-179612501-2026-00775InjuryAvailableexact di

Showing the most recent 200 of 868 linked reports.

Showing 1–15 of 200
Regulatory clearances

    Predicate lineage

    K934738

    Cited as predicate by: K111442

    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
    2025-07-16NAINo action indicatedCovidien LLC0
    2025-07-16NAINo action indicatedCovidien LLC0
    2024-11-21NAINo action indicatedCovidien, LP0
    2024-11-21NAINo action indicatedCovidien, LP0
    2022-11-18VAIVoluntary action indicatedCovidien LP1
    2022-11-18VAIVoluntary action indicatedCovidien LP1
    2022-09-08VAIVoluntary action indicatedCovidien0
    2022-09-08VAIVoluntary action indicatedCovidien0
    2022-04-28OAIOfficial action indicatedCovidien2
    2022-04-28OAIOfficial action indicatedCovidien2
    2020-02-28VAIVoluntary action indicatedCovidien, LP1
    2020-02-28VAIVoluntary action indicatedCovidien, LP1
    2018-09-19NAINo action indicatedCovidien0
    2018-09-19NAINo action indicatedCovidien0
    2017-09-22VAIVoluntary action indicatedCovidien, LLC2
    2017-09-22VAIVoluntary action indicatedCovidien, LLC2
    2017-08-09NAINo action indicatedCovidien0
    2017-08-09NAINo action indicatedCovidien0
    2016-10-31NAINo action indicatedCovidien0
    2016-10-31NAINo action indicatedCovidien0
    2012-06-14WLWarning LetterCovidien, LP—
    2012-06-14WLWarning LetterCovidien, LP—
    2011-10-04WLWarning LetterOridion Medical 1987 Ltd.—
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