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LEISEGANG

Model 50501 · Coopersurgical, Inc. · DI 60888937009967

GEH — Unit, Cryosurgical, Accessories · Class II · 21 CFR 878.4350

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 (14)

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: 14

13452019-01: 0 reports for this device; peer average 4/device2019-02: 0 reports for this device; peer average 1.25/device2019-03: 0 reports for this device; peer average 1.8/device2019-04: 0 reports for this device; peer average 2/device2019-05: 0 reports for this device; peer average 1.75/device2019-06: 0 reports for this device; peer average 1.5/device2019-07: 0 reports for this device; peer average 2.24/device2019-08: 1 reports for this device; peer average 1.89/device2019-09: 0 reports for this device; peer average 2.38/device2019-10: 0 reports for this device; peer average 2.46/device2019-11: 0 reports for this device; peer average 4.11/device2019-12: 0 reports for this device; peer average 3/device2020-01: 0 reports for this device; peer average 3/device2020-02: 1 reports for this device; peer average 5/device2020-03: 0 reports for this device; peer average 2.85/device2020-04: 0 reports for this device; peer average 4.25/device2020-05: 0 reports for this device; peer average 2.5/device2020-06: 0 reports for this device; peer average 2.75/device2020-07: 0 reports for this device; peer average 2.38/device2020-08: 0 reports for this device; peer average 2.82/device2020-09: 0 reports for this device; peer average 3.14/device2020-10: 2 reports for this device; peer average 1.25/device2020-11: 0 reports for this device; peer average 5/device2020-12: 0 reports for this device; peer average 1.22/device2021-01: 1 reports for this device; peer average 1.8/device2021-02: 0 reports for this device; peer average 5/device2021-03: 0 reports for this device; peer average 2.38/device2021-04: 0 reports for this device; peer average 1.9/device2021-05: 0 reports for this device; peer average 2.13/device2021-06: 1 reports for this device; peer average 2.25/device2021-07: 0 reports for this device; peer average 2/device2021-08: 1 reports for this device; peer average 2.8/device2021-09: 1 reports for this device; peer average 1.86/device2021-10: 0 reports for this device; peer average 1.33/device2021-11: 0 reports for this device; peer average 3.33/device2021-12: 0 reports for this device; peer average 2.67/device2022-01: 0 reports for this device; peer average 2.36/device2022-02: 0 reports for this device; peer average 1.25/device2022-03: 0 reports for this device; peer average 2/device2022-04: 1 reports for this device; peer average 1.77/device2022-05: 1 reports for this device; peer average 1.75/device2022-06: 0 reports for this device; peer average 2/device2022-07: 2 reports for this device; peer average 2.1/device2022-08: 0 reports for this device; peer average 3.57/device2022-09: 0 reports for this device; peer average 2.11/device2022-10: 0 reports for this device; peer average 2.1/device2022-11: 0 reports for this device; peer average 2.4/device2022-12: 0 reports for this device; peer average 1.43/device2023-01: 0 reports for this device; peer average 2.14/device2023-02: 0 reports for this device; peer average 1.3/device2023-03: 0 reports for this device; peer average 2.38/device2023-04: 1 reports for this device; peer average 1.7/device2023-05: 0 reports for this device; peer average 1.25/device2023-06: 0 reports for this device; peer average 1.29/device2023-07: 1 reports for this device; peer average 1.57/device2023-08: 0 reports for this device; peer average 3.2/device2023-09: 0 reports for this device; peer average 1.71/device2023-10: 0 reports for this device; peer average 1.45/device2023-11: 0 reports for this device; peer average 3/device2023-12: 0 reports for this device; peer average 1/device2024-01: 0 reports for this device; peer average 1.25/device2024-02: 0 reports for this device; peer average 1.44/device2024-03: 0 reports for this device; peer average 1.43/device2024-04: 0 reports for this device; peer average 1/device2024-05: 0 reports for this device; peer average 1/device2024-06: 0 reports for this device; peer average 1.4/device2024-07: 0 reports for this device; peer average 1.4/device2024-08: 0 reports for this device; peer average 1.33/device2024-09: 0 reports for this device; peer average 1.67/device2024-10: 0 reports for this device; peer average 2.17/device2024-11: 0 reports for this device; peer average 2/device2024-12: 0 reports for this device; peer average 2.5/device2025-01: 0 reports for this device; peer average 1.43/device2025-02: 0 reports for this device; peer average 1.33/device2025-03: 0 reports for this device; peer average 1.3/device2025-04: 0 reports for this device; peer average 1.86/device2025-05: 0 reports for this device; peer average 1.64/device2025-07: 0 reports for this device; peer average 2/device2025-08: 0 reports for this device; peer average 1.67/device2025-09: 0 reports for this device; peer average 2.2/device2025-10: 0 reports for this device; peer average 1.33/device2025-11: 0 reports for this device; peer average 1.89/device2025-12: 0 reports for this device; peer average 3.17/device2026-01: 0 reports for this device; peer average 3/device2026-02: 0 reports for this device; peer average 3/device2026-03: 0 reports for this device; peer average 2.08/device2026-04: 0 reports for this device; peer average 2.57/device2026-05: 0 reports for this device; peer average 3.17/device2026-06: 0 reports for this device; peer average 2.71/device0102030405060708091011120102030405060708091011120102030405060708091011120102030405060708091011120102030405060708091011120102030405060708091011120102030405070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0104
2019-0201.25
2019-0301.8
2019-0402
2019-0501.75
2019-0601.5
2019-0702.24
2019-0811.89
2019-0902.38
2019-1002.46
2019-1104.11
2019-1203
2020-0103
2020-0215
2020-0302.85
2020-0404.25
2020-0502.5
2020-0602.75
2020-0702.38
2020-0802.82
2020-0903.14
2020-1021.25
2020-1105
2020-1201.22
2021-0111.8
2021-0205
2021-0302.38
2021-0401.9
2021-0502.13
2021-0612.25
2021-0702
2021-0812.8
2021-0911.86
2021-1001.33
2021-1103.33
2021-1202.67
2022-0102.36
2022-0201.25
2022-0302
2022-0411.77
2022-0511.75
2022-0602
2022-0722.1
2022-0803.57
2022-0902.11
2022-1002.1
2022-1102.4
2022-1201.43
2023-0102.14
2023-0201.3
2023-0302.38
2023-0411.7
2023-0501.25
2023-0601.29
2023-0711.57
2023-0803.2
2023-0901.71
2023-1001.45
2023-1103
2023-1201
2024-0101.25
2024-0201.44
2024-0301.43
2024-0401
2024-0501
2024-0601.4
2024-0701.4
2024-0801.33
2024-0901.67
2024-1002.17
2024-1102
2024-1202.5
2025-0101.43
2025-0201.33
2025-0301.3
2025-0401.86
2025-0501.64
2025-0702
2025-0801.67
2025-0902.2
2025-1001.33
2025-1101.89
2025-1203.17
2026-0103
2026-0203
2026-0302.08
2026-0402.57
2026-0503.17
2026-0602.71
This device (reports/month)Average device in GEH (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Manufacturer compliance record — Coopersurgical, Inc.

  • Warning Letter 2015-06-09 CooperSurgical, Inc.
  • Warning Letter 2015-06-09 CooperSurgical, Inc.
  • Warning Letter 2013-04-25 Lone Star Medical Products, Inc.
  • Warning Letter 2012-07-11 Leisegang Feinmechanick-Optik GmbH
  • VAI 2024-02-01 CooperSurgical, Inc. · 0 citations
  • NAI 2023-05-16 CooperSurgical, Inc. · 0 citations
  • NAI 2023-05-16 CooperSurgical, Inc. · 0 citations
  • VAI 2023-04-27 Lone Star Medical Products, Inc. · 5 citations
  • NAI 2022-12-15 Leisegang Feinmechanick-Optik GmbH · 0 citations
  • VAI 2021-07-15 CooperSurgical, Inc. · 4 citations
  • VAI 2021-07-15 CooperSurgical, Inc. · 4 citations
  • NAI 2019-08-01 CooperSurgical, Inc. · 2 citations
  • NAI 2018-05-02 Lone Star Medical Products, Inc. · 0 citations
  • NAI 2017-12-07 CooperSurgical, Inc. · 0 citations
  • NAI 2017-12-07 CooperSurgical, Inc. · 0 citations
  • NAI 2017-05-04 Lone Star Medical Products, Inc. · 0 citations
  • NAI 2016-03-31 CooperSurgical, Inc. · 0 citations
  • NAI 2016-03-31 CooperSurgical, Inc. · 0 citations
  • NAI 2015-12-10 Leisegang Feinmechanick-Optik GmbH · 0 citations
  • OAI 2014-12-17 CooperSurgical, Inc. · 8 citations
  • OAI 2014-12-17 CooperSurgical, Inc. · 8 citations
  • NAI 2014-12-01 CooperSurgical, Inc. · 0 citations
  • NAI 2014-12-01 CooperSurgical, Inc. · 0 citations
  • VAI 2014-09-23 Lone Star Medical Products, Inc. · 0 citations