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Unnamed device
Model 242302 · Medos International Sàrl · DI 10886705028702
FCW — Light Source, Fiberoptic, Routine · Class II · 21 CFR 876.1500
GCJ — Laparoscope, General & Plastic Surgery · 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 (432)
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: 429 · Injury: 3
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
2.38
2019-02
0
3.51
2019-03
0
2.91
2019-04
0
3.08
2019-05
2
2.4
2019-06
4
3.5
2019-07
4
2.43
2019-08
4
2.43
2019-09
2
2.47
2019-10
13
2.79
2019-11
12
2.22
2019-12
2
2.35
2020-01
6
2.61
2020-02
0
2.68
2020-03
1
2.29
2020-04
0
2.49
2020-05
0
2.09
2020-06
3
2.76
2020-07
2
2.73
2020-08
3
4.28
2020-09
0
4.35
2020-10
9
3.98
2020-11
0
4.36
2020-12
1
3.77
2021-01
0
3.97
2021-02
2
3.87
2021-03
0
4.82
2021-04
0
4.64
2021-05
2
4.01
2021-06
3
4.27
2021-07
0
3.81
2021-08
0
3.86
2021-09
1
3.87
2021-10
1
3.94
2021-11
1
3.38
2021-12
2
4.36
2022-01
0
4.56
2022-02
1
4.94
2022-03
1
5.49
2022-04
1
6.29
2022-05
0
5.57
2022-06
2
5.99
2022-07
0
6.26
2022-08
1
6.25
2022-09
1
5.56
2022-10
2
5.39
2022-11
1
5.47
2022-12
3
6.03
2023-01
1
5.68
2023-02
1
4.81
2023-03
2
5.73
2023-04
0
5.38
2023-05
0
5.81
2023-06
0
6.94
2023-07
5
6.1
2023-08
10
6.31
2023-09
8
5.98
2023-10
8
6.34
2023-11
16
5.83
2023-12
2
5.92
2024-01
5
5.6
2024-02
4
6.09
2024-03
7
5.56
2024-04
4
6.33
2024-05
1
5.23
2024-06
5
7.01
2024-07
8
5.8
2024-08
9
6.6
2024-09
3
6.24
2024-10
4
6.99
2024-11
1
4.46
2024-12
7
4.75
2025-01
12
4.4
2025-02
12
4.09
2025-03
16
5.2
2025-04
4
4.69
2025-05
17
4.83
2025-06
15
4.6
2025-07
20
4.85
2025-08
22
5.61
2025-09
13
4.05
2025-10
7
4.56
2025-11
15
4.9
2025-12
3
5.97
2026-01
16
4.91
2026-02
14
4.99
2026-03
13
5.89
2026-04
17
6.26
2026-05
4
5.71
2026-06
8
4.91
This device (reports/month)Average device in FCW, GCJ (reports/device/month)