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Sonicision
Model SCD391 · Covidien LP · DI 10884521052659
LFL — Instrument, Ultrasonic Surgical
UDILibrary device dossier · generated 2026-09-13 · 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 (119)
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: 112 · Injury: 7
Monthly adverse-event reports for this device versus the product-code average.
Month
This device (reports)
Product-code average (reports per device)
2019-01
4
21.43
2019-02
3
18.76
2019-03
3
17.38
2019-04
1
19.33
2019-05
5
13.96
2019-06
4
13.78
2019-07
5
13.72
2019-08
6
17.95
2019-09
2
18.36
2019-10
5
18.02
2019-11
4
15.86
2019-12
5
17.13
2020-01
4
16.71
2020-02
3
20.62
2020-03
6
18.02
2020-04
4
17.91
2020-05
3
18.04
2020-06
5
23
2020-07
3
18.62
2020-08
4
16.63
2020-09
1
17.67
2020-10
0
14.94
2020-11
0
24.82
2020-12
4
22.21
2021-01
2
15.96
2021-02
2
16.49
2021-03
6
19.12
2021-04
2
15.19
2021-05
4
15.95
2021-06
0
19
2021-07
1
16.37
2021-08
0
18
2021-09
2
23.38
2021-10
0
22.3
2021-11
0
22.43
2021-12
1
30.38
2022-01
1
17.63
2022-02
0
20.54
2022-03
1
24.04
2022-04
0
20.64
2022-05
0
19.24
2022-06
0
25.56
2022-07
0
14.88
2022-08
3
22.97
2022-09
0
23.4
2022-10
1
24.15
2022-11
1
27.41
2022-12
1
24.35
2023-01
2
25.31
2023-02
1
18
2023-03
1
17.71
2023-04
0
24.73
2023-05
1
20.82
2023-06
0
21.58
2023-07
0
19.96
2023-08
0
18.26
2023-09
0
17.14
2023-10
0
20.16
2023-11
0
16.89
2023-12
0
23.32
2024-01
0
18.64
2024-02
1
16.59
2024-03
0
13.58
2024-04
0
14.97
2024-05
0
12.78
2024-06
0
18.13
2024-07
0
13.33
2024-08
0
15.55
2024-09
0
17.28
2024-10
0
12.35
2024-11
0
11.41
2024-12
0
16.73
2025-01
1
13.56
2025-02
0
13.63
2025-03
0
12.54
2025-04
0
11.36
2025-05
0
16.95
2025-06
0
13.06
2025-07
0
18
2025-08
0
17.47
2025-09
0
14.61
2025-10
0
11.11
2025-11
0
10.08
2025-12
0
16.79
2026-01
0
14.68
2026-02
0
15.06
2026-03
0
11.26
2026-04
0
12.27
2026-05
0
12.42
2026-06
0
16.46
This device (reports/month)Average device in LFL (reports/device/month)