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.
63 linked reportsMalfunction 62Injury 1
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 0 | 2 |
| 2019-02 | 1 | 1.4 |
| 2019-03 | 0 | 1.86 |
| 2019-04 | 0 | 1.63 |
| 2019-05 | 2 | 2.9 |
| 2019-06 | 0 | 1.5 |
| 2019-07 | 2 | 2.8 |
| 2019-08 | 0 | 3 |
| 2019-09 | 3 | 4.17 |
| 2019-10 | 0 | 6 |
| 2019-11 | 0 | 3.5 |
| 2019-12 | 0 | 1.88 |
| 2020-01 | 0 | 2 |
| 2020-02 | 1 | 2.29 |
| 2020-03 | 0 | 2.4 |
| 2020-04 | 0 | 1 |
| 2020-05 | 1 | 2 |
| 2020-06 | 1 | 2 |
| 2020-07 | 0 | 1.25 |
| 2020-08 | 0 | 2.67 |
| 2020-09 | 0 | 1 |
| 2020-10 | 1 | 3 |
| 2020-11 | 1 | 2.88 |
| 2020-12 | 1 | 1.5 |
| 2021-01 | 0 | 2.67 |
| 2021-02 | 0 | 4.2 |
| 2021-03 | 0 | 3.86 |
| 2021-04 | 1 | 4 |
| 2021-05 | 0 | 7.71 |
| 2021-06 | 0 | 5.25 |
| 2021-07 | 2 | 5.25 |
| 2021-08 | 0 | 3.83 |
| 2021-09 | 0 | 5 |
| 2021-10 | 0 | 15.33 |
| 2021-11 | 2 | 5.67 |
| 2021-12 | 1 | 9.29 |
| 2022-01 | 5 | 2.5 |
| 2022-02 | 1 | 5.25 |
| 2022-03 | 1 | 6.2 |
| 2022-04 | 3 | 4.33 |
| 2022-05 | 3 | 7.71 |
| 2022-06 | 1 | 12.8 |
| 2022-07 | 1 | 7.83 |
| 2022-08 | 0 | 8.67 |
| 2022-09 | 0 | 3.63 |
| 2022-10 | 0 | 8.8 |
| 2022-11 | 3 | 9.6 |
| 2022-12 | 0 | 4.75 |
| 2023-01 | 2 | 6.4 |
| 2023-02 | 0 | 7.57 |
| 2023-03 | 0 | 5.56 |
| 2023-04 | 1 | 3.5 |
| 2023-05 | 2 | 6.63 |
| 2023-06 | 1 | 5.5 |
| 2023-07 | 0 | 3.43 |
| 2023-08 | 0 | 6 |
| 2023-09 | 2 | 3.67 |
| 2023-10 | 4 | 5.14 |
| 2023-11 | 0 | 3.17 |
| 2023-12 | 0 | 3.67 |
| 2024-01 | 0 | 3.83 |
| 2024-02 | 0 | 2.67 |
| 2024-03 | 1 | 2.6 |
| 2024-04 | 0 | 4.57 |
| 2024-05 | 1 | 3.8 |
| 2024-06 | 1 | 2.5 |
| 2024-07 | 0 | 3.5 |
| 2024-08 | 4 | 2.86 |
| 2024-09 | 0 | 2.25 |
| 2024-10 | 0 | 2.83 |
| 2024-11 | 0 | 3.6 |
| 2024-12 | 0 | 2.2 |
| 2025-01 | 0 | 3.5 |
| 2025-02 | 0 | 3.5 |
| 2025-03 | 0 | 2.75 |
| 2025-04 | 2 | 5.2 |
| 2025-05 | 0 | 4.75 |
| 2025-06 | 2 | 1.6 |
| 2025-07 | 0 | 3.5 |
| 2025-08 | 0 | 3 |
| 2025-09 | 2 | 2 |
| 2025-10 | 0 | 4.5 |
| 2025-11 | 0 | 6.2 |
| 2025-12 | 0 | 4 |
| 2026-01 | 0 | 4 |
| 2026-02 | 0 | 3.25 |
| 2026-03 | 0 | 4.17 |
| 2026-04 | 0 | 4 |
| 2026-05 | 0 | 6.2 |
| 2026-06 | 0 | 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-0257-2022 | 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 | 1587 Units | clearance family |
| 2021-09-29 | Z-0258-2022 | 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 |
| 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 |
| 2019-04-23 | Z-1840-2019 | Class II | Terminated | 2.5A slow blow fuses may have been installed in the LEEP RPECISION Generator rather than the appropriate 3.15A slow blow fuses.Distribution: US Nationwide Distribution in the states of CA, CT, IN, MA, MI, MN, NC, NV, NY, OH, TX, WA and WI. | 19 | clearance family |
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2025-09-19 | 1216677-2025-00040 | Malfunction | Available | exact di |
| 2025-06-16 | 1216677-2025-00034 | Malfunction | Available | exact di |
| 2025-04-02 | 1216677-2025-00014 | Malfunction | Available | exact di |
| 2024-08-22 | 1216677-2024-00045 | Malfunction | Available | exact di |
| 2024-08-21 | 1216677-2024-00043 | Malfunction | Available | exact di |
| 2024-06-25 | MW5156625 | Malfunction | Available | model number |
| 2024-05-01 | 1216677-2024-00019 | Malfunction | Available | model number |
| 2024-03-06 | 1216677-2024-00007 | Malfunction | Available | model number |
| 2023-10-24 | 1216677-2023-00137 | Malfunction | Available | exact di |
| 2023-10-13 | 1216677-2023-00135 | Malfunction | Available | exact di |
| 2023-09-25 | 1216677-2023-00132 | Malfunction | Available | exact di |
| 2023-06-05 | MW5118161 | Injury | Available | model number |
| 2023-05-22 | 1216677-2023-00082 | Malfunction | Available | exact di |
| 2023-04-25 | 1216677-2023-00066 | Malfunction | Available | model number |
| 2023-01-26 | 1216677-2023-00008 | Malfunction | Available | model number |
Showing the most recent 52 of 63 linked reports.
Showing 1–15 of 52
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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