Print-ready dossier — use your browser's print dialog to save as PDF.
4K CAMERA HEAD
Model OLYMPUS CH-S400-XZ-EA · OLYMPUS MEDICAL SYSTEMS CORP. · DI 04953170375552
FET — Endoscopic Video Imaging System/Component, Gastroenterology-Urology · Class II · 21 CFR 876.1500
NWB — Endoscope, Accessories, Narrow Band Spectrum · Class II · 21 CFR 876.1500
UDILibrary device dossier · generated 2026-09-15 · 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 (2296)
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: 2289 · 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
0
4.7
2019-02
0
3.4
2019-03
0
7.2
2019-04
0
13.23
2019-05
0
4.62
2019-06
0
3.5
2019-07
0
7.22
2019-08
0
3.33
2019-09
0
3.04
2019-10
0
3.36
2019-11
0
4.46
2019-12
0
3.43
2020-01
0
3.29
2020-02
0
6.15
2020-03
0
3.3
2020-04
0
3.33
2020-05
0
4.58
2020-06
0
4.43
2020-07
2
8.51
2020-08
1
6.64
2020-09
1
6.27
2020-10
5
8
2020-11
3
8.01
2020-12
8
9.79
2021-01
10
9.88
2021-02
5
8.9
2021-03
9
12.32
2021-04
6
11.06
2021-05
15
10.53
2021-06
13
8.79
2021-07
19
9.92
2021-08
7
10.57
2021-09
12
13.5
2021-10
16
9.62
2021-11
7
10.46
2021-12
14
13.08
2022-01
16
10.29
2022-02
19
11.72
2022-03
33
14.92
2022-04
30
14.96
2022-05
19
14.5
2022-06
39
14.59
2022-07
30
11.84
2022-08
30
11.64
2022-09
48
10.97
2022-10
38
11.52
2022-11
41
10.1
2022-12
45
11.06
2023-01
24
10.73
2023-02
32
11.12
2023-03
43
13.94
2023-04
54
12.47
2023-05
53
11.83
2023-06
39
10.03
2023-07
35
10.35
2023-08
45
12.82
2023-09
21
11.96
2023-10
48
12.94
2023-11
38
12.69
2023-12
41
12.02
2024-01
49
13.63
2024-02
58
14.99
2024-03
67
16.58
2024-04
56
14.37
2024-05
58
13.64
2024-06
65
16.31
2024-07
71
16.14
2024-08
44
13.92
2024-09
55
15.03
2024-10
80
18.79
2024-11
30
11.13
2024-12
20
9.25
2025-01
34
9.63
2025-02
10
7.55
2025-03
30
8.84
2025-04
44
9.55
2025-05
29
8.87
2025-06
31
9.12
2025-07
38
9.46
2025-08
56
10.76
2025-09
16
7.57
2025-10
44
12.9
2025-11
36
18
2025-12
32
33.13
2026-01
31
27.5
2026-02
37
15.56
2026-03
33
15.61
2026-04
40
24.06
2026-05
55
25.6
2026-06
33
23.12
This device (reports/month)Average device in FET, NWB (reports/device/month)