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AESCULAP
Model PL536R · Aesculap AG · DI 04038653241149
OCW — Endoscopic Tissue Approximation Device · Class II · 21 CFR 876.1500
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 (42)
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: 24 · Injury: 18
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
4.33
2019-02
0
5.22
2019-03
4
5.13
2019-04
2
5.93
2019-05
0
5.62
2019-06
8
4.83
2019-07
0
5.82
2019-08
0
3.1
2019-09
0
3.7
2019-10
0
4.36
2019-11
2
3.78
2019-12
0
5.45
2020-01
0
4.56
2020-02
0
2.78
2020-03
0
4.5
2020-04
0
3.1
2020-05
0
2
2020-06
0
2.44
2020-07
4
3.77
2020-08
0
2.3
2020-09
0
4.22
2020-10
0
4.55
2020-11
0
4.6
2020-12
0
3.54
2021-01
0
3.67
2021-02
0
3.25
2021-03
2
4
2021-04
2
3.77
2021-05
0
2.92
2021-06
0
4.33
2021-07
0
2.92
2021-08
0
4.17
2021-09
0
3.43
2021-10
0
2.91
2021-11
0
3.36
2021-12
2
3.75
2022-01
0
4
2022-02
0
4.33
2022-03
0
3.4
2022-04
2
3.27
2022-05
0
6.4
2022-06
2
6.67
2022-07
0
5
2022-08
0
4.67
2022-09
0
2.93
2022-10
5
3.82
2022-11
2
3.18
2022-12
0
2.83
2023-01
0
3.67
2023-02
0
3.5
2023-03
0
3.69
2023-04
0
3.55
2023-05
0
3.39
2023-06
2
2.68
2023-07
0
3.75
2023-08
0
3.25
2023-09
0
3.07
2023-10
0
5.38
2023-11
0
3.22
2023-12
3
4.73
2024-01
0
4.55
2024-02
0
3.22
2024-03
0
2.73
2024-04
0
3.75
2024-05
0
2.14
2024-06
0
3.54
2024-07
0
2.58
2024-08
0
2.71
2024-09
0
3.21
2024-10
0
3.6
2024-11
0
3.43
2024-12
0
1.8
2025-01
0
5
2025-02
0
4.15
2025-03
0
4.33
2025-04
0
4.22
2025-05
0
4.45
2025-06
0
4.65
2025-07
0
5.56
2025-08
0
4.33
2025-09
0
2.5
2025-10
0
3.13
2025-11
0
4.64
2025-12
0
6.5
2026-01
0
4.29
2026-02
0
4.42
2026-03
0
5.57
2026-04
0
7.07
2026-05
0
11.14
2026-06
0
7.69
This device (reports/month)Average device in OCW (reports/device/month)