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AESCULAP
Model EJ995 · Aesculap AG · DI 04038653316199
HIF — Insufflator, Laparoscopic · Class II · 21 CFR 884.1730
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 (0)
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.
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
2.2
2019-02
0
1
2019-03
0
2.3
2019-04
0
4.78
2019-05
0
1.3
2019-06
0
2
2019-07
0
5
2019-08
0
2.4
2019-09
0
6.5
2019-10
0
1.8
2019-11
0
1
2019-12
0
2
2020-01
0
1.71
2020-02
0
1.8
2020-03
0
3.5
2020-04
0
4.8
2020-05
0
3.5
2020-06
0
4.83
2020-07
0
9.57
2020-08
0
7.17
2020-09
0
7.86
2020-10
0
10.5
2020-11
0
8.8
2020-12
0
11.75
2021-01
0
14.63
2021-02
0
13.2
2021-03
0
11.17
2021-04
0
17.5
2021-05
0
9.75
2021-06
0
9.71
2021-07
0
12
2021-08
0
14.86
2021-09
0
13.13
2021-10
0
13.22
2021-11
0
20.29
2021-12
0
33.75
2022-01
0
12.42
2022-02
0
15.43
2022-03
0
18.86
2022-04
0
22
2022-05
0
20
2022-06
0
14.63
2022-07
0
11.75
2022-08
0
13.8
2022-09
0
9.33
2022-10
0
8.33
2022-11
0
11
2022-12
0
10.25
2023-01
0
7
2023-02
0
8.83
2023-03
0
32
2023-04
0
8.83
2023-05
0
5.56
2023-06
0
18
2023-07
0
16.25
2023-08
0
7.18
2023-09
0
8.86
2023-10
0
8.78
2023-11
0
9.5
2023-12
0
13.14
2024-01
0
23.25
2024-02
0
9.83
2024-03
0
6.29
2024-04
0
5.83
2024-05
0
12.5
2024-06
0
17.17
2024-07
0
21.5
2024-08
0
24
2024-09
0
26.8
2024-10
0
28.83
2024-11
0
10
2024-12
0
7.8
2025-01
0
4.43
2025-02
0
4.8
2025-03
0
2.83
2025-04
0
2.17
2025-05
0
1.78
2025-06
0
1.78
2025-07
0
2.63
2025-08
0
10.5
2025-09
0
3.4
2025-10
0
4.1
2025-11
0
7.2
2025-12
0
3.5
2026-01
0
1.77
2026-02
0
4
2026-03
0
5.11
2026-04
0
2.33
2026-05
0
2.46
2026-06
0
2.57
This device (reports/month)Average device in HIF (reports/device/month)