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Sonicision

Model SCD396 · Covidien LP · DI 10884521807877

LFL — Instrument, Ultrasonic Surgical

UDILibrary device dossier · generated 2026-09-12 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.

Recall history (0)

No recalls linked in the loaded window.

Adverse-event reports — MAUDE (12)

Caveat (required reading): 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 is a reporting baseline (average device in the same product code), not a risk measure.

Malfunction: 12

81523302019-01: 0 reports for this device; peer average 21.43/device2019-02: 0 reports for this device; peer average 18.76/device2019-03: 0 reports for this device; peer average 17.38/device2019-04: 0 reports for this device; peer average 19.33/device2019-05: 0 reports for this device; peer average 13.96/device2019-06: 0 reports for this device; peer average 13.78/device2019-07: 0 reports for this device; peer average 13.72/device2019-08: 0 reports for this device; peer average 17.95/device2019-09: 0 reports for this device; peer average 18.36/device2019-10: 0 reports for this device; peer average 18.02/device2019-11: 0 reports for this device; peer average 15.86/device2019-12: 0 reports for this device; peer average 17.13/device2020-01: 0 reports for this device; peer average 16.71/device2020-02: 0 reports for this device; peer average 20.62/device2020-03: 1 reports for this device; peer average 18.02/device2020-04: 0 reports for this device; peer average 17.91/device2020-05: 0 reports for this device; peer average 18.04/device2020-06: 0 reports for this device; peer average 23/device2020-07: 0 reports for this device; peer average 18.62/device2020-08: 1 reports for this device; peer average 16.63/device2020-09: 0 reports for this device; peer average 17.67/device2020-10: 0 reports for this device; peer average 14.94/device2020-11: 0 reports for this device; peer average 24.82/device2020-12: 1 reports for this device; peer average 22.21/device2021-01: 1 reports for this device; peer average 15.96/device2021-02: 2 reports for this device; peer average 16.49/device2021-03: 2 reports for this device; peer average 19.12/device2021-04: 0 reports for this device; peer average 15.19/device2021-05: 1 reports for this device; peer average 15.95/device2021-06: 1 reports for this device; peer average 19/device2021-07: 1 reports for this device; peer average 16.37/device2021-08: 1 reports for this device; peer average 18/device2021-09: 0 reports for this device; peer average 23.38/device2021-10: 0 reports for this device; peer average 22.3/device2021-11: 0 reports for this device; peer average 22.43/device2021-12: 0 reports for this device; peer average 30.38/device2022-01: 0 reports for this device; peer average 17.63/device2022-02: 0 reports for this device; peer average 20.54/device2022-03: 0 reports for this device; peer average 24.04/device2022-04: 0 reports for this device; peer average 20.64/device2022-05: 0 reports for this device; peer average 19.24/device2022-06: 0 reports for this device; peer average 25.56/device2022-07: 0 reports for this device; peer average 14.88/device2022-08: 0 reports for this device; peer average 22.97/device2022-09: 0 reports for this device; peer average 23.4/device2022-10: 0 reports for this device; peer average 24.15/device2022-11: 0 reports for this device; peer average 27.41/device2022-12: 0 reports for this device; peer average 24.35/device2023-01: 0 reports for this device; peer average 25.31/device2023-02: 0 reports for this device; peer average 18/device2023-03: 0 reports for this device; peer average 17.71/device2023-04: 0 reports for this device; peer average 24.73/device2023-05: 0 reports for this device; peer average 20.82/device2023-06: 0 reports for this device; peer average 21.58/device2023-07: 0 reports for this device; peer average 19.96/device2023-08: 0 reports for this device; peer average 18.26/device2023-09: 0 reports for this device; peer average 17.14/device2023-10: 0 reports for this device; peer average 20.16/device2023-11: 0 reports for this device; peer average 16.89/device2023-12: 0 reports for this device; peer average 23.32/device2024-01: 0 reports for this device; peer average 18.64/device2024-02: 0 reports for this device; peer average 16.59/device2024-03: 0 reports for this device; peer average 13.58/device2024-04: 0 reports for this device; peer average 14.97/device2024-05: 0 reports for this device; peer average 12.78/device2024-06: 0 reports for this device; peer average 18.13/device2024-07: 0 reports for this device; peer average 13.33/device2024-08: 0 reports for this device; peer average 15.55/device2024-09: 0 reports for this device; peer average 17.28/device2024-10: 0 reports for this device; peer average 12.35/device2024-11: 0 reports for this device; peer average 11.41/device2024-12: 0 reports for this device; peer average 16.73/device2025-01: 0 reports for this device; peer average 13.56/device2025-02: 0 reports for this device; peer average 13.63/device2025-03: 0 reports for this device; peer average 12.54/device2025-04: 0 reports for this device; peer average 11.36/device2025-05: 0 reports for this device; peer average 16.95/device2025-06: 0 reports for this device; peer average 13.06/device2025-07: 0 reports for this device; peer average 18/device2025-08: 0 reports for this device; peer average 17.47/device2025-09: 0 reports for this device; peer average 14.61/device2025-10: 0 reports for this device; peer average 11.11/device2025-11: 0 reports for this device; peer average 10.08/device2025-12: 0 reports for this device; peer average 16.79/device2026-01: 0 reports for this device; peer average 14.68/device2026-02: 0 reports for this device; peer average 15.06/device2026-03: 0 reports for this device; peer average 11.26/device2026-04: 0 reports for this device; peer average 12.27/device2026-05: 0 reports for this device; peer average 12.42/device2026-06: 0 reports for this device; peer average 16.46/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-01021.43
2019-02018.76
2019-03017.38
2019-04019.33
2019-05013.96
2019-06013.78
2019-07013.72
2019-08017.95
2019-09018.36
2019-10018.02
2019-11015.86
2019-12017.13
2020-01016.71
2020-02020.62
2020-03118.02
2020-04017.91
2020-05018.04
2020-06023
2020-07018.62
2020-08116.63
2020-09017.67
2020-10014.94
2020-11024.82
2020-12122.21
2021-01115.96
2021-02216.49
2021-03219.12
2021-04015.19
2021-05115.95
2021-06119
2021-07116.37
2021-08118
2021-09023.38
2021-10022.3
2021-11022.43
2021-12030.38
2022-01017.63
2022-02020.54
2022-03024.04
2022-04020.64
2022-05019.24
2022-06025.56
2022-07014.88
2022-08022.97
2022-09023.4
2022-10024.15
2022-11027.41
2022-12024.35
2023-01025.31
2023-02018
2023-03017.71
2023-04024.73
2023-05020.82
2023-06021.58
2023-07019.96
2023-08018.26
2023-09017.14
2023-10020.16
2023-11016.89
2023-12023.32
2024-01018.64
2024-02016.59
2024-03013.58
2024-04014.97
2024-05012.78
2024-06018.13
2024-07013.33
2024-08015.55
2024-09017.28
2024-10012.35
2024-11011.41
2024-12016.73
2025-01013.56
2025-02013.63
2025-03012.54
2025-04011.36
2025-05016.95
2025-06013.06
2025-07018
2025-08017.47
2025-09014.61
2025-10011.11
2025-11010.08
2025-12016.79
2026-01014.68
2026-02015.06
2026-03011.26
2026-04012.27
2026-05012.42
2026-06016.46
This device (reports/month)Average device in LFL (reports/device/month)

Regulatory clearances

  • K101797 SESE 2011-02-24 (k number procode)

Predicate lineage

K101797 — cites (transitively): K002906 (d1), K042777 (d1), K060245 (d1) — cited as predicate by K141371, K143562, K151359, K151511, K153371, K170955, K173627, K180149, K200427

Lineage extracted from public 510(k) summary text (heuristic).

Manufacturer compliance record — Covidien LP

  • Warning Letter 2012-06-14 Covidien, LP
  • Warning Letter 2012-06-14 Covidien, LP
  • Warning Letter 2011-10-04 Oridion Medical 1987 Ltd.
  • NAI 2025-07-16 Covidien LLC · 0 citations
  • NAI 2025-07-16 Covidien LLC · 0 citations
  • NAI 2024-11-21 Covidien, LP · 0 citations
  • NAI 2024-11-21 Covidien, LP · 0 citations
  • VAI 2022-11-18 Covidien LP · 1 citations
  • VAI 2022-11-18 Covidien LP · 1 citations
  • VAI 2022-09-08 Covidien · 0 citations
  • VAI 2022-09-08 Covidien · 0 citations
  • OAI 2022-04-28 Covidien · 2 citations
  • OAI 2022-04-28 Covidien · 2 citations
  • VAI 2020-02-28 Covidien, LP · 1 citations
  • VAI 2020-02-28 Covidien, LP · 1 citations
  • NAI 2018-09-19 Covidien · 0 citations
  • NAI 2018-09-19 Covidien · 0 citations
  • VAI 2017-09-22 Covidien, LLC · 2 citations
  • VAI 2017-09-22 Covidien, LLC · 2 citations
  • NAI 2017-08-09 Covidien · 0 citations
  • NAI 2017-08-09 Covidien · 0 citations
  • NAI 2016-10-31 Covidien · 0 citations
  • NAI 2016-10-31 Covidien · 0 citations