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WALLACH

Model 909075 · Coopersurgical, Inc. · DI 00888937013993

HGI — Electrocautery, Gynecologic (And Accessories) · Class II · 21 CFR 884.4120

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 (9)

InitiatedRecall #ClassStatusReasonLink basis
2021-09-29Z-0263-2022Class IIOpen, ClassifiedXXXk number procode
2021-09-29Z-0259-2022Class IIOpen, ClassifiedCoagulate function may not operate with the use of the Hand Switch, failure of the device to coagulate tissue may lead to a prolonged procedure requiring medical intervention to control any intraoperative bleeding and complete the case.k number procode
2021-09-29Z-0260-2022Class IIOpen, ClassifiedCoagulate function may not operate with the use of the Hand Switch, failure of the device to coagulate tissue may lead to a prolonged procedure requiring medical intervention to control any intraoperative bleeding and complete the case.k number procode
2021-09-29Z-0261-2022Class IIOpen, ClassifiedCoagulate function may not operate with the use of the Hand Switch, failure of the device to coagulate tissue may lead to a prolonged procedure requiring medical intervention to control any intraoperative bleeding and complete the case.k number procode
2021-09-29Z-0262-2022Class IIOpen, ClassifiedCoagulate function may not operate with the use of the Hand Switch, failure of the device to coagulate tissue may lead to a prolonged procedure requiring medical intervention to control any intraoperative bleeding and complete the case.k number procode
2019-10-16Z-0600-2020Class IITerminatedPotential for the Quantum 2000 Electrosurgery Generator, part numbers 909075, 909075-05 and 909075-05W, to cease to either cut, coagulate, or blend during a procedure when the foot pedal is used for activation.k number procode
2019-10-16Z-0601-2020Class IITerminatedPotential for the Quantum 2000 Electrosurgery Generator, part numbers 909075, 909075-05 and 909075-05W, to cease to either cut, coagulate, or blend during a procedure when the foot pedal is used for activation.k number procode
2019-10-16Z-0602-2020Class IITerminatedPotential for the Quantum 2000 Electrosurgery Generator, part numbers 909075, 909075-05 and 909075-05W, to cease to either cut, coagulate, or blend during a procedure when the foot pedal is used for activation.k number procode
2019-06-18Z-2057-2019Class IITerminatedThe products' cut, coagulate, or blend function may not operate with the use of the Foot Pedal.k number procode

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: 22 · Injury: 2

4811152019-01: 1 reports for this device; peer average 2/device2019-02: 0 reports for this device; peer average 1.4/device2019-03: 1 reports for this device; peer average 1.86/device2019-04: 3 reports for this device; peer average 1.63/device2019-05: 1 reports for this device; peer average 2.9/device2019-06: 2 reports for this device; peer average 1.5/device2019-07: 1 reports for this device; peer average 2.8/device2019-08: 2 reports for this device; peer average 3/device2019-09: 0 reports for this device; peer average 4.17/device2019-10: 0 reports for this device; peer average 6/device2019-11: 1 reports for this device; peer average 3.5/device2019-12: 0 reports for this device; peer average 1.88/device2020-01: 0 reports for this device; peer average 2/device2020-02: 1 reports for this device; peer average 2.29/device2020-03: 0 reports for this device; peer average 2.4/device2020-04: 1 reports for this device; peer average 1/device2020-05: 0 reports for this device; peer average 2/device2020-06: 0 reports for this device; peer average 2/device2020-07: 0 reports for this device; peer average 1.25/device2020-08: 0 reports for this device; peer average 2.67/device2020-09: 1 reports for this device; peer average 1/device2020-10: 1 reports for this device; peer average 3/device2020-11: 1 reports for this device; peer average 2.88/device2020-12: 0 reports for this device; peer average 1.5/device2021-01: 0 reports for this device; peer average 2.67/device2021-02: 0 reports for this device; peer average 4.2/device2021-03: 0 reports for this device; peer average 3.86/device2021-04: 0 reports for this device; peer average 4/device2021-05: 0 reports for this device; peer average 7.71/device2021-06: 0 reports for this device; peer average 5.25/device2021-07: 0 reports for this device; peer average 5.25/device2021-08: 0 reports for this device; peer average 3.83/device2021-09: 0 reports for this device; peer average 5/device2021-10: 0 reports for this device; peer average 15.33/device2021-11: 0 reports for this device; peer average 5.67/device2021-12: 0 reports for this device; peer average 9.29/device2022-01: 0 reports for this device; peer average 2.5/device2022-02: 1 reports for this device; peer average 5.25/device2022-03: 2 reports for this device; peer average 6.2/device2022-04: 1 reports for this device; peer average 4.33/device2022-05: 0 reports for this device; peer average 7.71/device2022-06: 0 reports for this device; peer average 12.8/device2022-07: 0 reports for this device; peer average 7.83/device2022-08: 0 reports for this device; peer average 8.67/device2022-09: 1 reports for this device; peer average 3.63/device2022-10: 0 reports for this device; peer average 8.8/device2022-11: 0 reports for this device; peer average 9.6/device2022-12: 0 reports for this device; peer average 4.75/device2023-01: 0 reports for this device; peer average 6.4/device2023-02: 0 reports for this device; peer average 7.57/device2023-03: 0 reports for this device; peer average 5.56/device2023-04: 0 reports for this device; peer average 3.5/device2023-05: 0 reports for this device; peer average 6.63/device2023-06: 0 reports for this device; peer average 5.5/device2023-07: 0 reports for this device; peer average 3.43/device2023-08: 0 reports for this device; peer average 6/device2023-09: 0 reports for this device; peer average 3.67/device2023-10: 0 reports for this device; peer average 5.14/device2023-11: 0 reports for this device; peer average 3.17/device2023-12: 0 reports for this device; peer average 3.67/device2024-01: 0 reports for this device; peer average 3.83/device2024-02: 0 reports for this device; peer average 2.67/device2024-03: 0 reports for this device; peer average 2.6/device2024-04: 0 reports for this device; peer average 4.57/device2024-05: 0 reports for this device; peer average 3.8/device2024-06: 0 reports for this device; peer average 2.5/device2024-07: 0 reports for this device; peer average 3.5/device2024-08: 0 reports for this device; peer average 2.86/device2024-09: 0 reports for this device; peer average 2.25/device2024-10: 0 reports for this device; peer average 2.83/device2024-11: 0 reports for this device; peer average 3.6/device2024-12: 0 reports for this device; peer average 2.2/device2025-01: 0 reports for this device; peer average 3.5/device2025-02: 0 reports for this device; peer average 3.5/device2025-03: 0 reports for this device; peer average 2.75/device2025-04: 0 reports for this device; peer average 5.2/device2025-05: 0 reports for this device; peer average 4.75/device2025-06: 0 reports for this device; peer average 1.6/device2025-07: 0 reports for this device; peer average 3.5/device2025-08: 0 reports for this device; peer average 3/device2025-09: 0 reports for this device; peer average 2/device2025-10: 0 reports for this device; peer average 4.5/device2025-11: 0 reports for this device; peer average 6.2/device2025-12: 0 reports for this device; peer average 4/device2026-01: 0 reports for this device; peer average 4/device2026-02: 0 reports for this device; peer average 3.25/device2026-03: 2 reports for this device; peer average 4.17/device2026-04: 0 reports for this device; peer average 4/device2026-05: 0 reports for this device; peer average 6.2/device2026-06: 0 reports for this device; peer average 6.17/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0112
2019-0201.4
2019-0311.86
2019-0431.63
2019-0512.9
2019-0621.5
2019-0712.8
2019-0823
2019-0904.17
2019-1006
2019-1113.5
2019-1201.88
2020-0102
2020-0212.29
2020-0302.4
2020-0411
2020-0502
2020-0602
2020-0701.25
2020-0802.67
2020-0911
2020-1013
2020-1112.88
2020-1201.5
2021-0102.67
2021-0204.2
2021-0303.86
2021-0404
2021-0507.71
2021-0605.25
2021-0705.25
2021-0803.83
2021-0905
2021-10015.33
2021-1105.67
2021-1209.29
2022-0102.5
2022-0215.25
2022-0326.2
2022-0414.33
2022-0507.71
2022-06012.8
2022-0707.83
2022-0808.67
2022-0913.63
2022-1008.8
2022-1109.6
2022-1204.75
2023-0106.4
2023-0207.57
2023-0305.56
2023-0403.5
2023-0506.63
2023-0605.5
2023-0703.43
2023-0806
2023-0903.67
2023-1005.14
2023-1103.17
2023-1203.67
2024-0103.83
2024-0202.67
2024-0302.6
2024-0404.57
2024-0503.8
2024-0602.5
2024-0703.5
2024-0802.86
2024-0902.25
2024-1002.83
2024-1103.6
2024-1202.2
2025-0103.5
2025-0203.5
2025-0302.75
2025-0405.2
2025-0504.75
2025-0601.6
2025-0703.5
2025-0803
2025-0902
2025-1004.5
2025-1106.2
2025-1204
2026-0104
2026-0203.25
2026-0324.17
2026-0404
2026-0506.2
2026-0606.17
This device (reports/month)Average device in HGI (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