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Model MAJ-2255 · OLYMPUS MEDICAL SYSTEMS CORP. · DI 04953170374692
EOB — Nasopharyngoscope (Flexible Or Rigid) · Class II · 21 CFR 874.4760
EOQ — Bronchoscope (Flexible Or Rigid) · Class II · 21 CFR 874.4680
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 2026-09-16 · 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 (1)
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: 1
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
3.3
2019-03
0
4.77
2019-04
0
10.78
2019-05
0
3.17
2019-06
0
3.52
2019-07
0
3.32
2019-08
0
3.06
2019-09
0
2.7
2019-10
0
2.99
2019-11
0
2.79
2019-12
0
2.95
2020-01
0
2.88
2020-02
0
3.78
2020-03
0
2.62
2020-04
0
3.22
2020-05
0
3.13
2020-06
0
3.65
2020-07
0
4.63
2020-08
0
5.16
2020-09
0
4.92
2020-10
0
5.66
2020-11
0
6.13
2020-12
0
6.79
2021-01
1
6.26
2021-02
0
5.7
2021-03
0
8.03
2021-04
0
6.97
2021-05
0
6.71
2021-06
0
6.05
2021-07
0
5.61
2021-08
0
6.51
2021-09
0
7.05
2021-10
0
6.16
2021-11
0
5.79
2021-12
0
7.45
2022-01
0
7.47
2022-02
0
8.04
2022-03
0
9.48
2022-04
0
10.37
2022-05
0
9.12
2022-06
0
9.96
2022-07
0
9.25
2022-08
0
9.11
2022-09
0
8.08
2022-10
0
8.15
2022-11
0
8.03
2022-12
0
8.86
2023-01
0
8.91
2023-02
0
7.53
2023-03
0
9.96
2023-04
0
8.46
2023-05
0
8.4
2023-06
0
8.53
2023-07
0
8.18
2023-08
0
9.45
2023-09
0
9.1
2023-10
0
9.38
2023-11
0
9.59
2023-12
0
8.77
2024-01
0
8.62
2024-02
0
9.44
2024-03
0
9.63
2024-04
0
9.7
2024-05
0
9.5
2024-06
0
11.61
2024-07
0
10.88
2024-08
0
10.78
2024-09
0
10.72
2024-10
0
12.65
2024-11
0
9
2024-12
0
7.55
2025-01
0
7.86
2025-02
0
6.97
2025-03
0
7.63
2025-04
0
7.77
2025-05
0
7.52
2025-06
0
7.38
2025-07
0
7.98
2025-08
0
8.39
2025-09
0
6.47
2025-10
0
9.15
2025-11
0
11.82
2025-12
0
18.92
2026-01
0
14.94
2026-02
0
10.96
2026-03
0
11.96
2026-04
0
14.91
2026-05
0
15.76
2026-06
0
13.53
This device (reports/month)Average device in EOB, EOQ, FGB, GCJ, HET, 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