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COMMUNICATION CABLE 1.8M
Model MAJ-1948 · OLYMPUS MEDICAL SYSTEMS CORP. · DI 04953170305023
FCX — Insufflator, Automatic Carbon-Dioxide For Endoscope · Class II · 21 CFR 876.1500
HIF — Insufflator, Laparoscopic · Class II · 21 CFR 884.1730
OSV — Insufflator, Endoscopic Vessel Harvesting · 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 (1)
Initiated
Recall #
Class
Status
Reason
Link basis
2023-09-22
Z-0075-2024
Class I
Open, Classified
There have been reports of patients suffering arrhythmias, reported as short cardiac arrests, during surgical procedures where UHI-4s were used. These events may have been due to an over insufflation of the abdominal cavity resulting from use of the UHI-4 during the procedures.
k number procode
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
1.67
2019-02
0
1
2019-03
0
2.27
2019-04
0
4.54
2019-05
0
1.25
2019-06
0
1.75
2019-07
0
5
2019-08
0
2.1
2019-09
0
5.86
2019-10
0
1.7
2019-11
0
1
2019-12
0
2.25
2020-01
0
1.53
2020-02
0
1.81
2020-03
0
4
2020-04
0
5.91
2020-05
0
4.9
2020-06
0
6.58
2020-07
0
14.82
2020-08
0
10.7
2020-09
0
13.55
2020-10
0
14.42
2020-11
0
16.86
2020-12
0
21.17
2021-01
0
20.27
2021-02
0
17.45
2021-03
0
16.3
2021-04
0
25
2021-05
0
14
2021-06
0
14.73
2021-07
0
17.15
2021-08
0
21.54
2021-09
0
17.4
2021-10
0
19.77
2021-11
0
31.5
2021-12
0
40.22
2022-01
0
23.82
2022-02
0
27.27
2022-03
0
29.31
2022-04
0
32.33
2022-05
0
30.82
2022-06
0
19.88
2022-07
0
16.57
2022-08
0
27.29
2022-09
0
15.3
2022-10
0
11.83
2022-11
0
19.5
2022-12
0
13.33
2023-01
0
11.25
2023-02
0
17.38
2023-03
0
40.43
2023-04
0
14.3
2023-05
0
7.78
2023-06
0
29.29
2023-07
0
21
2023-08
0
10.8
2023-09
0
11.69
2023-10
0
15.27
2023-11
0
14.67
2023-12
0
20.92
2024-01
0
37.29
2024-02
0
14.55
2024-03
0
10.68
2024-04
0
9.05
2024-05
0
20.7
2024-06
0
28.4
2024-07
0
33.57
2024-08
0
44
2024-09
0
48.63
2024-10
0
44.45
2024-11
0
16.17
2024-12
0
13
2025-01
0
5.92
2025-02
0
6.5
2025-03
0
3.82
2025-04
0
2.75
2025-05
0
2
2025-06
0
2.82
2025-07
0
2.74
2025-08
0
8.78
2025-09
0
5
2025-10
0
6.8
2025-11
0
9.1
2025-12
0
3.67
2026-01
0
1.87
2026-02
0
4.17
2026-03
0
5.62
2026-04
0
2.6
2026-05
0
2.52
2026-06
0
3.19
This device (reports/month)Average device in FCX, HIF, OSV (reports/device/month)
Regulatory clearances
K122180 SESE 2012-11-13 (k number procode)
Predicate lineage
K122180 — cited as predicate by K161554, K170784, K243527
Lineage extracted from public 510(k) summary text (heuristic).
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