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Mara

Model DDK-16-050 · Coopersurgical, Inc. · DI 00888937026887

MNB — Device, Thermal Ablation, Endometrial · Class III

UDILibrary device dossier · generated 2026-09-13 · 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 (24)

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 · Injury: 10

3710142019-01: 0 reports for this device; peer average 2.29/device2019-02: 0 reports for this device; peer average 3/device2019-03: 0 reports for this device; peer average 4.43/device2019-04: 0 reports for this device; peer average 3.67/device2019-05: 0 reports for this device; peer average 5.83/device2019-06: 0 reports for this device; peer average 1.75/device2019-07: 0 reports for this device; peer average 4.17/device2019-08: 0 reports for this device; peer average 5/device2019-09: 0 reports for this device; peer average 2.57/device2019-10: 0 reports for this device; peer average 4.22/device2019-11: 0 reports for this device; peer average 4.25/device2019-12: 0 reports for this device; peer average 2.5/device2020-01: 0 reports for this device; peer average 2.78/device2020-02: 0 reports for this device; peer average 3.2/device2020-03: 0 reports for this device; peer average 2.43/device2020-04: 0 reports for this device; peer average 2.17/device2020-05: 0 reports for this device; peer average 3.33/device2020-06: 0 reports for this device; peer average 2.5/device2020-07: 0 reports for this device; peer average 2.71/device2020-08: 0 reports for this device; peer average 3.5/device2020-09: 0 reports for this device; peer average 4.86/device2020-10: 0 reports for this device; peer average 2.83/device2020-11: 0 reports for this device; peer average 3.6/device2020-12: 0 reports for this device; peer average 8/device2021-01: 0 reports for this device; peer average 2.67/device2021-02: 0 reports for this device; peer average 4/device2021-03: 0 reports for this device; peer average 8.2/device2021-04: 0 reports for this device; peer average 6.5/device2021-05: 0 reports for this device; peer average 7.8/device2021-06: 0 reports for this device; peer average 8/device2021-07: 1 reports for this device; peer average 4.83/device2021-08: 0 reports for this device; peer average 8.67/device2021-09: 0 reports for this device; peer average 3.71/device2021-10: 0 reports for this device; peer average 4/device2021-11: 0 reports for this device; peer average 13/device2021-12: 0 reports for this device; peer average 13.75/device2022-01: 0 reports for this device; peer average 4.33/device2022-02: 0 reports for this device; peer average 2.17/device2022-03: 1 reports for this device; peer average 5.83/device2022-04: 2 reports for this device; peer average 2.25/device2022-05: 1 reports for this device; peer average 2.5/device2022-06: 0 reports for this device; peer average 3.43/device2022-07: 0 reports for this device; peer average 5.5/device2022-08: 0 reports for this device; peer average 7.75/device2022-09: 0 reports for this device; peer average 3.4/device2022-10: 3 reports for this device; peer average 5.43/device2022-11: 0 reports for this device; peer average 4.63/device2022-12: 0 reports for this device; peer average 11.2/device2023-01: 2 reports for this device; peer average 5.83/device2023-02: 3 reports for this device; peer average 3.71/device2023-03: 0 reports for this device; peer average 5.57/device2023-04: 0 reports for this device; peer average 7.2/device2023-05: 0 reports for this device; peer average 5.6/device2023-06: 0 reports for this device; peer average 6.17/device2023-07: 0 reports for this device; peer average 5.75/device2023-08: 0 reports for this device; peer average 6/device2023-09: 3 reports for this device; peer average 3.22/device2023-10: 0 reports for this device; peer average 4/device2023-11: 4 reports for this device; peer average 5.44/device2023-12: 0 reports for this device; peer average 7/device2024-01: 0 reports for this device; peer average 4.22/device2024-02: 0 reports for this device; peer average 12.75/device2024-03: 0 reports for this device; peer average 6.17/device2024-04: 0 reports for this device; peer average 3.8/device2024-05: 0 reports for this device; peer average 10.5/device2024-06: 2 reports for this device; peer average 3.71/device2024-07: 0 reports for this device; peer average 2.75/device2024-08: 0 reports for this device; peer average 2.33/device2024-09: 0 reports for this device; peer average 5.67/device2024-10: 0 reports for this device; peer average 3.8/device2024-11: 0 reports for this device; peer average 5.5/device2024-12: 0 reports for this device; peer average 3/device2025-01: 2 reports for this device; peer average 4.56/device2025-02: 0 reports for this device; peer average 4.67/device2025-03: 0 reports for this device; peer average 6.33/device2025-04: 0 reports for this device; peer average 5.14/device2025-05: 0 reports for this device; peer average 7.25/device2025-06: 0 reports for this device; peer average 6.14/device2025-07: 0 reports for this device; peer average 3/device2025-08: 0 reports for this device; peer average 9/device2025-09: 0 reports for this device; peer average 4.17/device2025-10: 0 reports for this device; peer average 4/device2025-11: 0 reports for this device; peer average 3/device2025-12: 0 reports for this device; peer average 5.33/device2026-01: 0 reports for this device; peer average 5.5/device2026-02: 0 reports for this device; peer average 4.4/device2026-03: 0 reports for this device; peer average 11/device2026-04: 0 reports for this device; peer average 4.5/device2026-05: 0 reports for this device; peer average 2.33/device2026-06: 0 reports for this device; peer average 8.5/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0102.29
2019-0203
2019-0304.43
2019-0403.67
2019-0505.83
2019-0601.75
2019-0704.17
2019-0805
2019-0902.57
2019-1004.22
2019-1104.25
2019-1202.5
2020-0102.78
2020-0203.2
2020-0302.43
2020-0402.17
2020-0503.33
2020-0602.5
2020-0702.71
2020-0803.5
2020-0904.86
2020-1002.83
2020-1103.6
2020-1208
2021-0102.67
2021-0204
2021-0308.2
2021-0406.5
2021-0507.8
2021-0608
2021-0714.83
2021-0808.67
2021-0903.71
2021-1004
2021-11013
2021-12013.75
2022-0104.33
2022-0202.17
2022-0315.83
2022-0422.25
2022-0512.5
2022-0603.43
2022-0705.5
2022-0807.75
2022-0903.4
2022-1035.43
2022-1104.63
2022-12011.2
2023-0125.83
2023-0233.71
2023-0305.57
2023-0407.2
2023-0505.6
2023-0606.17
2023-0705.75
2023-0806
2023-0933.22
2023-1004
2023-1145.44
2023-1207
2024-0104.22
2024-02012.75
2024-0306.17
2024-0403.8
2024-05010.5
2024-0623.71
2024-0702.75
2024-0802.33
2024-0905.67
2024-1003.8
2024-1105.5
2024-1203
2025-0124.56
2025-0204.67
2025-0306.33
2025-0405.14
2025-0507.25
2025-0606.14
2025-0703
2025-0809
2025-0904.17
2025-1004
2025-1103
2025-1205.33
2026-0105.5
2026-0204.4
2026-03011
2026-0404.5
2026-0502.33
2026-0608.5
This device (reports/month)Average device in MNB (reports/device/month)

Regulatory clearances

  • P160047 OK30 2025-01-07 (k number procode)
  • P160047 APPR 2024-07-11 (k number procode)
  • P160047 APPR 2024-07-09 (k number procode)
  • P160047 OK30 2024-05-10 (k number procode)
  • P160047 APPR 2023-12-08 (k number procode)
  • P160047 APPR 2023-10-25 (k number procode)
  • P160047 APPR 2023-07-28 (k number procode)
  • P160047 OK30 2023-07-27 (k number procode)
  • P160047 APPR 2023-06-30 (k number procode)
  • P160047 OK30 2023-03-13 (k number procode)
  • P160047 OK30 2023-01-19 (k number procode)
  • P160047 OK30 2022-12-12 (k number procode)
  • P160047 OK30 2022-01-25 (k number procode)
  • P160047 OK30 2021-10-29 (k number procode)
  • P160047 APPR 2021-06-09 (k number procode)
  • P160047 OK30 2021-04-21 (k number procode)
  • P160047 OK30 2021-04-19 (k number procode)
  • P160047 OK30 2021-04-12 (k number procode)
  • P160047 OK30 2021-01-27 (k number procode)
  • P160047 OK30 2021-01-14 (k number procode)

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