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Roth Net Platinum
Model 00715050 · US Endoscopy · DI 00816765011973
FDI — Snare, Flexible · Class II · 21 CFR 876.4300
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 (16)
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
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
2.4
2019-02
0
3.32
2019-03
0
2.84
2019-04
0
3.02
2019-05
1
2.4
2019-06
0
3.43
2019-07
1
2.34
2019-08
0
2.48
2019-09
0
2.44
2019-10
0
2.73
2019-11
0
2.14
2019-12
1
2.28
2020-01
0
2.49
2020-02
0
2.65
2020-03
0
2.28
2020-04
0
2.47
2020-05
0
2.14
2020-06
0
3.08
2020-07
1
2.89
2020-08
0
4.28
2020-09
0
4.45
2020-10
0
3.84
2020-11
0
5.44
2020-12
0
3.73
2021-01
0
3.82
2021-02
0
3.72
2021-03
0
4.63
2021-04
0
4.41
2021-05
0
3.92
2021-06
0
3.91
2021-07
0
3.72
2021-08
0
3.78
2021-09
0
3.83
2021-10
0
3.83
2021-11
0
3.48
2021-12
0
4.3
2022-01
0
4.48
2022-02
0
4.84
2022-03
0
5.2
2022-04
0
6.16
2022-05
0
5.26
2022-06
0
5.51
2022-07
0
5.89
2022-08
0
6.06
2022-09
0
5.13
2022-10
0
4.92
2022-11
0
4.93
2022-12
0
5.64
2023-01
0
5.34
2023-02
0
4.6
2023-03
0
5.59
2023-04
0
5.36
2023-05
0
5.6
2023-06
0
6.72
2023-07
0
5.73
2023-08
0
5.91
2023-09
0
5.6
2023-10
0
6.06
2023-11
0
5.54
2023-12
0
5.81
2024-01
0
5.18
2024-02
0
5.82
2024-03
0
5.28
2024-04
0
5.98
2024-05
0
5.05
2024-06
0
6.79
2024-07
0
5.54
2024-08
2
6.17
2024-09
0
5.98
2024-10
0
6.65
2024-11
0
4.63
2024-12
2
4.95
2025-01
0
4.32
2025-02
0
3.89
2025-03
0
4.94
2025-04
0
4.41
2025-05
0
5.03
2025-06
0
4.4
2025-07
0
4.52
2025-08
2
5.09
2025-09
2
3.89
2025-10
0
4.42
2025-11
0
4.58
2025-12
0
5.81
2026-01
0
4.69
2026-02
0
4.93
2026-03
0
5.57
2026-04
4
6.15
2026-05
0
5.77
2026-06
0
4.84
This device (reports/month)Average device in FDI, GCJ (reports/device/month)