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Air/water valve
Model MH-438 · OLYMPUS MEDICAL SYSTEMS CORP. · DI 04953170071249
FDF — Colonoscope And Accessories, Flexible/Rigid · Class II · 21 CFR 876.1500
FDS — Gastroscope And Accessories, Flexible/Rigid · Class II · 21 CFR 876.1500
FDT — Duodenoscope And Accessories, Flexible/Rigid · Class II · 21 CFR 876.1500
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 2026-09-16 · 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 (18)
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: 16 · Death: 2
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
2019-02
0
2.86
2019-03
0
4.21
2019-04
2
6.72
2019-05
0
3.91
2019-06
0
3.3
2019-07
0
5.61
2019-08
0
2.73
2019-09
0
2.63
2019-10
0
2.93
2019-11
0
3.76
2019-12
0
3.19
2020-01
0
2.61
2020-02
0
4.5
2020-03
0
3.17
2020-04
0
2.83
2020-05
0
5.2
2020-06
2
3.57
2020-07
0
7.61
2020-08
0
5.23
2020-09
0
5.43
2020-10
0
6.32
2020-11
0
6.38
2020-12
0
8.66
2021-01
0
8.6
2021-02
0
9.19
2021-03
0
11.2
2021-04
0
10.29
2021-05
0
9.29
2021-06
2
8.09
2021-07
0
8.62
2021-08
0
8.75
2021-09
0
12
2021-10
0
8.69
2021-11
0
9.94
2021-12
0
12.07
2022-01
2
9.73
2022-02
0
12.16
2022-03
0
13.2
2022-04
0
13.5
2022-05
0
12.94
2022-06
0
13.66
2022-07
0
11.74
2022-08
2
11.86
2022-09
0
11.65
2022-10
0
11.84
2022-11
1
10.69
2022-12
2
11.53
2023-01
0
10.33
2023-02
0
10.62
2023-03
0
13.57
2023-04
0
12.86
2023-05
0
11.57
2023-06
1
11.03
2023-07
0
11.8
2023-08
0
12.95
2023-09
1
11.73
2023-10
0
13.29
2023-11
0
13.37
2023-12
1
12.32
2024-01
0
13.25
2024-02
0
13.7
2024-03
0
16
2024-04
0
13.12
2024-05
0
12.18
2024-06
0
13.61
2024-07
0
13.86
2024-08
0
11.6
2024-09
0
12.09
2024-10
0
15.65
2024-11
0
8.67
2024-12
0
7.26
2025-01
0
7.94
2025-02
0
6.75
2025-03
0
8.21
2025-04
0
8.5
2025-05
0
8.79
2025-06
0
9.18
2025-07
0
8.85
2025-08
0
10.5
2025-09
0
7.14
2025-10
0
12.94
2025-11
1
20.16
2025-12
0
39.56
2026-01
0
31.61
2026-02
1
18.46
2026-03
0
18.15
2026-04
0
26.31
2026-05
0
27.58
2026-06
0
26.71
This device (reports/month)Average device in FDF, FDS, FDT, FET, NWB (reports/device/month)
Regulatory clearances
None linked in the loaded window.
Manufacturer compliance record — OLYMPUS MEDICAL SYSTEMS CORP.
Warning Letter 2022-12-12 Olympus Medical Systems Corporation
Warning Letter 2018-03-09 Olympus Medical Systems Corporation
OAI 2022-09-09 Olympus Medical Systems Corporation · 1 citations
OAI 2015-04-24 Olympus Medical Systems Corporation · 2 citations