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Mystic

Model 10057 · Coopersurgical, Inc. · DI 00888937003109

HDB — Extractor, Vacuum, Fetal · Class II · 21 CFR 884.4340

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 (35)

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: 35

24682019-01: 0 reports for this device; peer average 2/device2019-02: 0 reports for this device; peer average 2/device2019-03: 2 reports for this device; peer average 1.67/device2019-04: 0 reports for this device; peer average 2/device2019-05: 0 reports for this device; peer average 1.5/device2019-06: 2 reports for this device; peer average 1.33/device2019-07: 0 reports for this device; peer average 1.5/device2019-08: 0 reports for this device; peer average 1/device2019-09: 0 reports for this device; peer average 2/device2019-10: 0 reports for this device; peer average 1/device2019-11: 6 reports for this device; peer average 3.25/device2019-12: 0 reports for this device; peer average 2/device2020-01: 0 reports for this device; peer average 2/device2020-02: 0 reports for this device; peer average 1.33/device2020-03: 4 reports for this device; peer average 4/device2020-04: 6 reports for this device; peer average 6/device2020-05: 4 reports for this device; peer average 4/device2020-06: 0 reports for this device; peer average 2/device2020-07: 0 reports for this device; peer average 2/device2020-09: 0 reports for this device; peer average 2/device2020-10: 0 reports for this device; peer average 1/device2020-11: 0 reports for this device; peer average 2/device2020-12: 0 reports for this device; peer average 2/device2021-01: 0 reports for this device; peer average 1/device2021-02: 0 reports for this device; peer average 4/device2021-04: 0 reports for this device; peer average 2/device2021-05: 4 reports for this device; peer average 3.33/device2021-06: 2 reports for this device; peer average 2/device2021-07: 2 reports for this device; peer average 2/device2021-11: 0 reports for this device; peer average 2/device2021-12: 0 reports for this device; peer average 3/device2022-01: 1 reports for this device; peer average 1/device2022-04: 0 reports for this device; peer average 2/device2022-05: 1 reports for this device; peer average 1/device2022-07: 0 reports for this device; peer average 1.33/device2022-08: 0 reports for this device; peer average 2/device2022-09: 0 reports for this device; peer average 1/device2022-10: 0 reports for this device; peer average 2/device2023-02: 0 reports for this device; peer average 2/device2023-03: 0 reports for this device; peer average 2/device2023-04: 0 reports for this device; peer average 1/device2023-05: 0 reports for this device; peer average 6/device2023-06: 0 reports for this device; peer average 2.5/device2023-08: 1 reports for this device; peer average 1/device2023-11: 0 reports for this device; peer average 2/device2024-01: 0 reports for this device; peer average 1.5/device2024-02: 0 reports for this device; peer average 6/device2024-03: 0 reports for this device; peer average 1/device2024-04: 0 reports for this device; peer average 4/device2024-06: 0 reports for this device; peer average 1.5/device2024-08: 0 reports for this device; peer average 2/device2024-10: 0 reports for this device; peer average 2/device2024-11: 0 reports for this device; peer average 3/device2024-12: 0 reports for this device; peer average 1/device2025-01: 0 reports for this device; peer average 2/device2025-04: 0 reports for this device; peer average 1/device2025-06: 0 reports for this device; peer average 1/device2025-10: 0 reports for this device; peer average 2.5/device2025-11: 0 reports for this device; peer average 2/device2026-01: 0 reports for this device; peer average 1/device2026-02: 0 reports for this device; peer average 1/device2026-03: 0 reports for this device; peer average 7.5/device2026-04: 0 reports for this device; peer average 2/device2026-06: 0 reports for this device; peer average 2/device01020304050607080910111201020304050607091011120102040506071112010405070809100203040506081101020304060810111201040610110102030406
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0102
2019-0202
2019-0321.67
2019-0402
2019-0501.5
2019-0621.33
2019-0701.5
2019-0801
2019-0902
2019-1001
2019-1163.25
2019-1202
2020-0102
2020-0201.33
2020-0344
2020-0466
2020-0544
2020-0602
2020-0702
2020-0902
2020-1001
2020-1102
2020-1202
2021-0101
2021-0204
2021-0402
2021-0543.33
2021-0622
2021-0722
2021-1102
2021-1203
2022-0111
2022-0402
2022-0511
2022-0701.33
2022-0802
2022-0901
2022-1002
2023-0202
2023-0302
2023-0401
2023-0506
2023-0602.5
2023-0811
2023-1102
2024-0101.5
2024-0206
2024-0301
2024-0404
2024-0601.5
2024-0802
2024-1002
2024-1103
2024-1201
2025-0102
2025-0401
2025-0601
2025-1002.5
2025-1102
2026-0101
2026-0201
2026-0307.5
2026-0402
2026-0602
This device (reports/month)Average device in HDB (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