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AESCULAP
Model PL579T · Aesculap AG · DI 04046963398835
FZP — Clip, Implantable · Class II · 21 CFR 878.4300
UDILibrary device dossier · generated 2026-09-11 · 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 (136)
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.
Injury: 91 · Malfunction: 45
Monthly adverse-event reports for this device versus the product-code average.
Month
This device (reports)
Product-code average (reports per device)
2019-01
0
9.07
2019-02
6
8.57
2019-03
0
12.63
2019-04
0
7.71
2019-05
0
11.6
2019-06
8
8.54
2019-07
4
8.04
2019-08
2
8.24
2019-09
2
8.9
2019-10
0
10.13
2019-11
0
9.05
2019-12
4
9.33
2020-01
0
12.14
2020-02
0
9.81
2020-03
0
14.35
2020-04
0
10.59
2020-05
0
5.25
2020-06
0
11.38
2020-07
2
9.04
2020-08
6
7.8
2020-09
2
10.18
2020-10
8
11.14
2020-11
0
14.81
2020-12
6
8.96
2021-01
0
9.95
2021-02
6
9.31
2021-03
7
10.66
2021-04
2
9.61
2021-05
3
6.71
2021-06
0
11.05
2021-07
3
7.93
2021-08
0
12.27
2021-09
0
8.94
2021-10
3
7.52
2021-11
3
7.83
2021-12
0
10.76
2022-01
0
9
2022-02
6
6.09
2022-03
0
7.55
2022-04
4
9.96
2022-05
4
7.58
2022-06
0
11.93
2022-07
0
8.33
2022-08
16
8.97
2022-09
0
10.41
2022-10
0
10.07
2022-11
4
9.12
2022-12
2
16.6
2023-01
2
10.33
2023-02
0
7.77
2023-03
0
9.2
2023-04
6
12.38
2023-05
0
8.15
2023-06
0
16.63
2023-07
0
11.26
2023-08
2
7.85
2023-09
0
14.69
2023-10
0
27.15
2023-11
0
25.5
2023-12
5
19.38
2024-01
0
19.8
2024-02
0
27.42
2024-03
0
18.08
2024-04
0
34.25
2024-05
2
13.94
2024-06
0
14.67
2024-07
0
8.54
2024-08
0
10.39
2024-09
0
18.93
2024-10
2
16.78
2024-11
0
17.14
2024-12
0
15.78
2025-01
0
17.15
2025-02
2
10.29
2025-03
0
20.08
2025-04
0
20.58
2025-05
0
18.5
2025-06
0
15.82
2025-07
0
16.69
2025-08
2
13.43
2025-09
0
15.56
2025-10
0
17.6
2025-11
0
15.55
2025-12
0
25.94
2026-01
0
21.23
2026-02
0
19.12
2026-03
0
17.8
2026-04
0
25.19
2026-05
0
15.94
2026-06
0
20.25
This device (reports/month)Average device in FZP (reports/device/month)