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SERFAS Energy

Model 0279401200 · STRYKER CORPORATION · DI 07613327057034

GEI — Electrosurgical, Cutting & Coagulation & Accessories · Class II · 21 CFR 878.4400

UDILibrary device dossier · generated 2026-09-06 · 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 (355)

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: 336 · Injury: 19

61217232019-01: 0 reports for this device; peer average 6.86/device2019-02: 3 reports for this device; peer average 4.35/device2019-03: 1 reports for this device; peer average 4.42/device2019-04: 2 reports for this device; peer average 6.12/device2019-05: 3 reports for this device; peer average 4.8/device2019-06: 3 reports for this device; peer average 5.04/device2019-07: 3 reports for this device; peer average 5.86/device2019-08: 3 reports for this device; peer average 6.1/device2019-09: 0 reports for this device; peer average 4.99/device2019-10: 2 reports for this device; peer average 5.85/device2019-11: 2 reports for this device; peer average 5.62/device2019-12: 4 reports for this device; peer average 5.41/device2020-01: 0 reports for this device; peer average 4.81/device2020-02: 1 reports for this device; peer average 5.57/device2020-03: 2 reports for this device; peer average 5.68/device2020-04: 0 reports for this device; peer average 3.57/device2020-05: 0 reports for this device; peer average 3.76/device2020-06: 0 reports for this device; peer average 5.14/device2020-07: 2 reports for this device; peer average 6.56/device2020-08: 1 reports for this device; peer average 4.64/device2020-09: 2 reports for this device; peer average 5.86/device2020-10: 1 reports for this device; peer average 5.55/device2020-11: 4 reports for this device; peer average 5.14/device2020-12: 3 reports for this device; peer average 5.31/device2021-01: 3 reports for this device; peer average 5.17/device2021-02: 4 reports for this device; peer average 4.89/device2021-03: 0 reports for this device; peer average 5.7/device2021-04: 3 reports for this device; peer average 5.26/device2021-05: 2 reports for this device; peer average 5.14/device2021-06: 6 reports for this device; peer average 5.83/device2021-07: 2 reports for this device; peer average 4.89/device2021-08: 10 reports for this device; peer average 4.3/device2021-09: 3 reports for this device; peer average 4.77/device2021-10: 11 reports for this device; peer average 6.17/device2021-11: 7 reports for this device; peer average 5.57/device2021-12: 1 reports for this device; peer average 5.56/device2022-01: 0 reports for this device; peer average 5.04/device2022-02: 7 reports for this device; peer average 5.15/device2022-03: 4 reports for this device; peer average 5.75/device2022-04: 5 reports for this device; peer average 4.98/device2022-05: 2 reports for this device; peer average 5.78/device2022-06: 8 reports for this device; peer average 6.3/device2022-07: 3 reports for this device; peer average 4.36/device2022-08: 5 reports for this device; peer average 4.59/device2022-09: 3 reports for this device; peer average 5/device2022-10: 5 reports for this device; peer average 4.76/device2022-11: 6 reports for this device; peer average 4.61/device2022-12: 11 reports for this device; peer average 4.04/device2023-01: 9 reports for this device; peer average 5.52/device2023-02: 7 reports for this device; peer average 4.59/device2023-03: 6 reports for this device; peer average 4.87/device2023-04: 5 reports for this device; peer average 4.78/device2023-05: 4 reports for this device; peer average 5.14/device2023-06: 5 reports for this device; peer average 4.78/device2023-07: 2 reports for this device; peer average 4.82/device2023-08: 3 reports for this device; peer average 4.44/device2023-09: 2 reports for this device; peer average 5.23/device2023-10: 8 reports for this device; peer average 5.1/device2023-11: 4 reports for this device; peer average 4.38/device2023-12: 10 reports for this device; peer average 4.79/device2024-01: 10 reports for this device; peer average 5.54/device2024-02: 4 reports for this device; peer average 5.46/device2024-03: 14 reports for this device; peer average 6.16/device2024-04: 5 reports for this device; peer average 6.04/device2024-05: 3 reports for this device; peer average 6.28/device2024-06: 1 reports for this device; peer average 5.39/device2024-07: 3 reports for this device; peer average 5.05/device2024-08: 2 reports for this device; peer average 5.01/device2024-09: 6 reports for this device; peer average 5.19/device2024-10: 6 reports for this device; peer average 5.7/device2024-11: 23 reports for this device; peer average 5.29/device2024-12: 17 reports for this device; peer average 4.06/device2025-01: 6 reports for this device; peer average 5.17/device2025-02: 5 reports for this device; peer average 4.46/device2025-03: 1 reports for this device; peer average 6.28/device2025-04: 1 reports for this device; peer average 4.39/device2025-05: 4 reports for this device; peer average 5.16/device2025-06: 4 reports for this device; peer average 5.08/device2025-07: 3 reports for this device; peer average 5.2/device2025-08: 1 reports for this device; peer average 5.45/device2025-09: 1 reports for this device; peer average 4.85/device2025-10: 2 reports for this device; peer average 5.14/device2025-11: 0 reports for this device; peer average 5.55/device2025-12: 1 reports for this device; peer average 5.81/device2026-01: 2 reports for this device; peer average 5.63/device2026-02: 4 reports for this device; peer average 5.98/device2026-03: 1 reports for this device; peer average 6.2/device2026-04: 3 reports for this device; peer average 5.43/device2026-05: 4 reports for this device; peer average 6.19/device2026-06: 0 reports for this device; peer average 5.56/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0106.86
2019-0234.35
2019-0314.42
2019-0426.12
2019-0534.8
2019-0635.04
2019-0735.86
2019-0836.1
2019-0904.99
2019-1025.85
2019-1125.62
2019-1245.41
2020-0104.81
2020-0215.57
2020-0325.68
2020-0403.57
2020-0503.76
2020-0605.14
2020-0726.56
2020-0814.64
2020-0925.86
2020-1015.55
2020-1145.14
2020-1235.31
2021-0135.17
2021-0244.89
2021-0305.7
2021-0435.26
2021-0525.14
2021-0665.83
2021-0724.89
2021-08104.3
2021-0934.77
2021-10116.17
2021-1175.57
2021-1215.56
2022-0105.04
2022-0275.15
2022-0345.75
2022-0454.98
2022-0525.78
2022-0686.3
2022-0734.36
2022-0854.59
2022-0935
2022-1054.76
2022-1164.61
2022-12114.04
2023-0195.52
2023-0274.59
2023-0364.87
2023-0454.78
2023-0545.14
2023-0654.78
2023-0724.82
2023-0834.44
2023-0925.23
2023-1085.1
2023-1144.38
2023-12104.79
2024-01105.54
2024-0245.46
2024-03146.16
2024-0456.04
2024-0536.28
2024-0615.39
2024-0735.05
2024-0825.01
2024-0965.19
2024-1065.7
2024-11235.29
2024-12174.06
2025-0165.17
2025-0254.46
2025-0316.28
2025-0414.39
2025-0545.16
2025-0645.08
2025-0735.2
2025-0815.45
2025-0914.85
2025-1025.14
2025-1105.55
2025-1215.81
2026-0125.63
2026-0245.98
2026-0316.2
2026-0435.43
2026-0546.19
2026-0605.56
This device (reports/month)Average device in GEI (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Manufacturer compliance record — STRYKER CORPORATION

  • Warning Letter 2017-04-06 Entellus Medical Inc.
  • Warning Letter 2015-04-08 Thermedx LLC
  • Injunction 2013-11-26 Physio-Control, Inc.
  • Warning Letter 2013-03-06 Stryker Corporation
  • Warning Letter 2013-03-06 Stryker Corporation
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