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Model OLYMPUS CH-S400-XZ-EB · OLYMPUS MEDICAL SYSTEMS CORP. · DI 04953170374609
EOB — Nasopharyngoscope (Flexible Or Rigid) · Class II · 21 CFR 874.4760
EOQ — Bronchoscope (Flexible Or Rigid) · Class II · 21 CFR 874.4680
FET — Endoscopic Video Imaging System/Component, Gastroenterology-Urology · Class II · 21 CFR 876.1500
FGB — Ureteroscope And Accessories, Flexible/Rigid · Class II · 21 CFR 876.1500
GCJ — Laparoscope, General & Plastic Surgery · Class II · 21 CFR 876.1500
HET — Laparoscope, Gynecologic (And Accessories) · Class II · 21 CFR 884.1720
NWB — Endoscope, Accessories, Narrow Band Spectrum · Class II · 21 CFR 876.1500
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 (2482)
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: 2468 · Injury: 14
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
2.73
2019-02
0
3.29
2019-03
0
4.74
2019-04
0
10.44
2019-05
0
3.16
2019-06
0
3.46
2019-07
0
3.27
2019-08
0
3.05
2019-09
0
2.7
2019-10
1
2.95
2019-11
0
2.78
2019-12
0
2.94
2020-01
0
2.88
2020-02
0
3.76
2020-03
0
2.61
2020-04
1
3.19
2020-05
3
3.17
2020-06
2
3.7
2020-07
12
4.73
2020-08
1
5.23
2020-09
4
5.04
2020-10
3
5.87
2020-11
5
6.22
2020-12
12
6.95
2021-01
4
6.4
2021-02
13
5.79
2021-03
19
8.07
2021-04
25
7.13
2021-05
20
6.86
2021-06
19
6.04
2021-07
12
5.84
2021-08
8
6.8
2021-09
11
7.51
2021-10
16
6.43
2021-11
18
6.03
2021-12
22
7.87
2022-01
34
7.54
2022-02
19
8.2
2022-03
33
9.8
2022-04
43
10.68
2022-05
40
9.52
2022-06
44
10.36
2022-07
44
9.49
2022-08
54
9.34
2022-09
34
8.39
2022-10
30
8.41
2022-11
35
8.09
2022-12
53
9.03
2023-01
39
9.06
2023-02
39
7.77
2023-03
59
10.28
2023-04
47
8.8
2023-05
42
8.62
2023-06
43
8.69
2023-07
39
8.39
2023-08
50
9.79
2023-09
51
9.44
2023-10
54
9.71
2023-11
53
9.84
2023-12
43
9.07
2024-01
42
9.15
2024-02
65
10.16
2024-03
67
10.4
2024-04
47
10.43
2024-05
62
10.33
2024-06
93
12.6
2024-07
78
11.83
2024-08
67
11.4
2024-09
65
11.56
2024-10
82
13.58
2024-11
51
9.3
2024-12
39
8.09
2025-01
27
8.3
2025-02
9
7.07
2025-03
32
7.83
2025-04
30
8.04
2025-05
22
7.6
2025-06
31
7.49
2025-07
33
8.08
2025-08
44
8.68
2025-09
17
6.53
2025-10
29
9.22
2025-11
18
11.77
2025-12
35
19.05
2026-01
18
15.04
2026-02
17
10.75
2026-03
22
11.99
2026-04
34
15.07
2026-05
31
15.73
2026-06
22
13.46
This device (reports/month)Average device in EOB, EOQ, FET, FGB, GCJ, HET, NWB (reports/device/month)