Adverse-event reports (MAUDE)
Read this first: 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 shows reporting volume for the average device in the same FDA product code — a reporting baseline, not a risk measure.
236 linked reportsMalfunction 234Injury 2
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 2 | 2 |
| 2019-02 | 1 | 1.4 |
| 2019-03 | 2 | 1.86 |
| 2019-04 | 1 | 1.63 |
| 2019-05 | 5 | 2.9 |
| 2019-06 | 2 | 1.5 |
| 2019-07 | 0 | 2.8 |
| 2019-08 | 4 | 3 |
| 2019-09 | 3 | 4.17 |
| 2019-10 | 5 | 6 |
| 2019-11 | 1 | 3.5 |
| 2019-12 | 2 | 1.88 |
| 2020-01 | 2 | 2 |
| 2020-02 | 5 | 2.29 |
| 2020-03 | 2 | 2.4 |
| 2020-04 | 1 | 1 |
| 2020-05 | 0 | 2 |
| 2020-06 | 3 | 2 |
| 2020-07 | 1 | 1.25 |
| 2020-08 | 5 | 2.67 |
| 2020-09 | 1 | 1 |
| 2020-10 | 3 | 3 |
| 2020-11 | 2 | 2.88 |
| 2020-12 | 1 | 1.5 |
| 2021-01 | 2 | 2.67 |
| 2021-02 | 3 | 4.2 |
| 2021-03 | 1 | 3.86 |
| 2021-04 | 4 | 4 |
| 2021-05 | 5 | 7.71 |
| 2021-06 | 5 | 5.25 |
| 2021-07 | 2 | 5.25 |
| 2021-08 | 1 | 3.83 |
| 2021-09 | 2 | 5 |
| 2021-10 | 7 | 15.33 |
| 2021-11 | 0 | 5.67 |
| 2021-12 | 3 | 9.29 |
| 2022-01 | 1 | 2.5 |
| 2022-02 | 4 | 5.25 |
| 2022-03 | 11 | 6.2 |
| 2022-04 | 1 | 4.33 |
| 2022-05 | 5 | 7.71 |
| 2022-06 | 0 | 12.8 |
| 2022-07 | 1 | 7.83 |
| 2022-08 | 3 | 8.67 |
| 2022-09 | 0 | 3.63 |
| 2022-10 | 6 | 8.8 |
| 2022-11 | 0 | 9.6 |
| 2022-12 | 0 | 4.75 |
| 2023-01 | 13 | 6.4 |
| 2023-02 | 0 | 7.57 |
| 2023-03 | 2 | 5.56 |
| 2023-04 | 0 | 3.5 |
| 2023-05 | 4 | 6.63 |
| 2023-06 | 5 | 5.5 |
| 2023-07 | 2 | 3.43 |
| 2023-08 | 2 | 6 |
| 2023-09 | 3 | 3.67 |
| 2023-10 | 5 | 5.14 |
| 2023-11 | 4 | 3.17 |
| 2023-12 | 6 | 3.67 |
| 2024-01 | 0 | 3.83 |
| 2024-02 | 0 | 2.67 |
| 2024-03 | 5 | 2.6 |
| 2024-04 | 1 | 4.57 |
| 2024-05 | 2 | 3.8 |
| 2024-06 | 4 | 2.5 |
| 2024-07 | 3 | 3.5 |
| 2024-08 | 2 | 2.86 |
| 2024-09 | 0 | 2.25 |
| 2024-10 | 2 | 2.83 |
| 2024-11 | 4 | 3.6 |
| 2024-12 | 1 | 2.2 |
| 2025-01 | 4 | 3.5 |
| 2025-02 | 0 | 3.5 |
| 2025-03 | 4 | 2.75 |
| 2025-04 | 8 | 5.2 |
| 2025-05 | 6 | 4.75 |
| 2025-06 | 0 | 1.6 |
| 2025-07 | 2 | 3.5 |
| 2025-08 | 0 | 3 |
| 2025-09 | 0 | 2 |
| 2025-10 | 1 | 4.5 |
| 2025-11 | 6 | 6.2 |
| 2025-12 | 2 | 4 |
| 2026-01 | 4 | 4 |
| 2026-02 | 0 | 3.25 |
| 2026-03 | 0 | 4.17 |
| 2026-04 | 2 | 4 |
| 2026-05 | 0 | 6.2 |
| 2026-06 | 6 | 6.17 |
Failure-mode summaryAI-generated
40 linked report narratives available — no AI summary generated yet.
Recall history
| Initiated | Recall # | Class | Status | Reason | Quantity | Link basis |
|---|---|---|---|---|---|---|
| 2021-09-29 | Z-0263-2022 | Class II | Open, Classified | XXXDistribution: US Nationwide Distribution Foreign: ARMENIA, BOLIVIA, CAMBODIA, CANADA, CHILE, CHINA, COSTA RICA, DOMINICAN REPUBLIC, ECUADOR, ENGLAND, GERMANY, HONG KONG, INDIA, INDONESIA, IRAN, ITALY, JORDAN, KENYA, MALAYSIA, MAURITIUS, MEXICO, NEW ZEALAND, NICARAGUA, NIGERIA, PHILIPPINES, PUERTO RICO, QATAR, RWANDA, SINGAPORE, SOUTH AFRICA, SRI LANKA, TAIWAN, TANZANIA, THAILAND, TRINIDAD, TURKEY, UGANDA, UNITED ARAB EMIRATES, VIETNAM | 154 Units | clearance family |
| 2021-09-29 | Z-0259-2022 | Class II | Open, Classified | Coagulate 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.Distribution: US Nationwide Distribution Foreign: ARMENIA, BOLIVIA, CAMBODIA, CANADA, CHILE, CHINA, COSTA RICA, DOMINICAN REPUBLIC, ECUADOR, ENGLAND, GERMANY, HONG KONG, INDIA, INDONESIA, IRAN, ITALY, JORDAN, KENYA, MALAYSIA, MAURITIUS, MEXICO, NEW ZEALAND, NICARAGUA, NIGERIA, PHILIPPINES, PUERTO RICO, QATAR, RWANDA, SINGAPORE, SOUTH AFRICA, SRI LANKA, TAIWAN, TANZANIA, THAILAND, TRINIDAD, TURKEY, UGANDA, UNITED ARAB EMIRATES, VIETNAM | 244 Units | clearance family |
| 2021-09-29 | Z-0260-2022 | Class II | Open, Classified | Coagulate 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.Distribution: US Nationwide Distribution Foreign: ARMENIA, BOLIVIA, CAMBODIA, CANADA, CHILE, CHINA, COSTA RICA, DOMINICAN REPUBLIC, ECUADOR, ENGLAND, GERMANY, HONG KONG, INDIA, INDONESIA, IRAN, ITALY, JORDAN, KENYA, MALAYSIA, MAURITIUS, MEXICO, NEW ZEALAND, NICARAGUA, NIGERIA, PHILIPPINES, PUERTO RICO, QATAR, RWANDA, SINGAPORE, SOUTH AFRICA, SRI LANKA, TAIWAN, TANZANIA, THAILAND, TRINIDAD, TURKEY, UGANDA, UNITED ARAB EMIRATES, VIETNAM | 75 Units | clearance family |
| 2021-09-29 | Z-0261-2022 | Class II | Open, Classified | Coagulate 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.Distribution: US Nationwide Distribution Foreign: ARMENIA, BOLIVIA, CAMBODIA, CANADA, CHILE, CHINA, COSTA RICA, DOMINICAN REPUBLIC, ECUADOR, ENGLAND, GERMANY, HONG KONG, INDIA, INDONESIA, IRAN, ITALY, JORDAN, KENYA, MALAYSIA, MAURITIUS, MEXICO, NEW ZEALAND, NICARAGUA, NIGERIA, PHILIPPINES, PUERTO RICO, QATAR, RWANDA, SINGAPORE, SOUTH AFRICA, SRI LANKA, TAIWAN, TANZANIA, THAILAND, TRINIDAD, TURKEY, UGANDA, UNITED ARAB EMIRATES, VIETNAM | 193 Units | clearance family |
| 2021-09-29 | Z-0262-2022 | Class II | Open, Classified | Coagulate 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.Distribution: US Nationwide Distribution Foreign: ARMENIA, BOLIVIA, CAMBODIA, CANADA, CHILE, CHINA, COSTA RICA, DOMINICAN REPUBLIC, ECUADOR, ENGLAND, GERMANY, HONG KONG, INDIA, INDONESIA, IRAN, ITALY, JORDAN, KENYA, MALAYSIA, MAURITIUS, MEXICO, NEW ZEALAND, NICARAGUA, NIGERIA, PHILIPPINES, PUERTO RICO, QATAR, RWANDA, SINGAPORE, SOUTH AFRICA, SRI LANKA, TAIWAN, TANZANIA, THAILAND, TRINIDAD, TURKEY, UGANDA, UNITED ARAB EMIRATES, VIETNAM | 700 Units | clearance family |
| 2019-10-16 | Z-0600-2020 | Class II | Terminated | Potential 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.Distribution: US: AL, AZ, CA, CO, FL, GA, HI, ID, IL, IN, LA, MA, ME, Ml, MT, ND, NJ, NV, NY, OK, PA, SC, SD, TN, TX, UT, VA, WA, & WV. International: China, Indonesia, South Africa, & Tanzania. | 105 | clearance family |
| 2019-10-16 | Z-0601-2020 | Class II | Terminated | Potential 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.Distribution: US: AL, AZ, CA, CO, FL, GA, HI, ID, IL, IN, LA, MA, ME, Ml, MT, ND, NJ, NV, NY, OK, PA, SC, SD, TN, TX, UT, VA, WA, & WV. International: China, Indonesia, South Africa, & Tanzania. | 110 | clearance family |
| 2019-10-16 | Z-0602-2020 | Class II | Terminated | Potential 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.Distribution: US: AL, AZ, CA, CO, FL, GA, HI, ID, IL, IN, LA, MA, ME, Ml, MT, ND, NJ, NV, NY, OK, PA, SC, SD, TN, TX, UT, VA, WA, & WV. International: China, Indonesia, South Africa, & Tanzania. | 4 | clearance family |
| 2019-06-18 | Z-2057-2019 | Class II | Terminated | The products' cut, coagulate, or blend function may not operate with the use of the Foot Pedal.Distribution: Nationwide domestic distribution. International distribution to Canada and Costa Rica. | 358 | clearance family |
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2026-06-02 | 1216677-2026-00045 | Malfunction | Available | exact di |
| 2026-06-02 | 1216677-2026-00044 | Malfunction | Available | exact di |
| 2026-06-01 | 1216677-2026-00043 | Malfunction | Available | exact di |
| 2026-04-21 | 1216677-2026-00034 | Malfunction | Available | exact di |
| 2026-01-23 | 1216677-2026-00003 | Malfunction | Available | exact di |
| 2026-01-06 | 1216677-2026-00002 | Malfunction | Available | exact di |
| 2025-12-16 | 1216677-2025-00058 | Malfunction | Available | exact di |
| 2025-11-24 | 1216677-2025-00052 | Malfunction | Available | exact di |
| 2025-11-05 | 1216677-2025-00050 | Malfunction | Available | exact di |
| 2025-11-05 | 1216677-2025-00051 | Malfunction | Available | exact di |
| 2025-10-06 | 1216677-2025-00042 | Malfunction | Available | model number |
| 2025-07-01 | 1216677-2025-00036 | Malfunction | Available | exact di |
| 2025-05-13 | 1216677-2025-00029 | Malfunction | Available | exact di |
| 2025-05-12 | 1216677-2025-00028 | Malfunction | Available | exact di |
| 2025-05-12 | 1216677-2025-00027 | Malfunction | Available | exact di |
Showing the most recent 189 of 236 linked reports.
Showing 1–15 of 189
Regulatory clearances
None linked.
Manufacturer compliance record
| Date | Type | Outcome | Facility | Citations |
|---|---|---|---|---|
| 2024-02-01 | VAI | Voluntary action indicated | CooperSurgical, Inc. | 0 |
| 2023-05-16 | NAI | No action indicated | CooperSurgical, Inc. | 0 |
| 2023-05-16 | NAI | No action indicated | CooperSurgical, Inc. | 0 |
| 2023-04-27 | VAI | Voluntary action indicated | Lone Star Medical Products, Inc. | 5 |
| 2022-12-15 | NAI | No action indicated | Leisegang Feinmechanick-Optik GmbH | 0 |
| 2021-07-15 | VAI | Voluntary action indicated | CooperSurgical, Inc. | 4 |
| 2021-07-15 | VAI | Voluntary action indicated | CooperSurgical, Inc. | 4 |
| 2019-08-01 | NAI | No action indicated | CooperSurgical, Inc. | 2 |
| 2018-05-02 | NAI | No action indicated | Lone Star Medical Products, Inc. | 0 |
| 2017-12-07 | NAI | No action indicated | CooperSurgical, Inc. | 0 |
| 2017-12-07 | NAI | No action indicated | CooperSurgical, Inc. | 0 |
| 2017-05-04 | NAI | No action indicated | Lone Star Medical Products, Inc. | 0 |
| 2016-03-31 | NAI | No action indicated | CooperSurgical, Inc. | 0 |
| 2016-03-31 | NAI | No action indicated | CooperSurgical, Inc. | 0 |
| 2015-12-10 | NAI | No action indicated | Leisegang Feinmechanick-Optik GmbH | 0 |
| 2015-06-09 | WL | Warning Letter | CooperSurgical, Inc. | — |
| 2015-06-09 | WL | Warning Letter | CooperSurgical, Inc. | — |
| 2014-12-17 | OAI | Official action indicated | CooperSurgical, Inc. | 8 |
| 2014-12-17 | OAI | Official action indicated | CooperSurgical, Inc. | 8 |
| 2014-12-01 | NAI | No action indicated | CooperSurgical, Inc. | 0 |
| 2014-12-01 | NAI | No action indicated | CooperSurgical, Inc. | 0 |
| 2014-09-23 | VAI | Voluntary action indicated | Lone Star Medical Products, Inc. | 0 |
| 2013-04-25 | WL | Warning Letter | Lone Star Medical Products, Inc. | — |
| 2012-07-11 | WL | Warning Letter | Leisegang Feinmechanick-Optik GmbH | — |
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