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.
113 linked reportsMalfunction 74Injury 39
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 0 | 2.29 |
| 2019-02 | 0 | 3 |
| 2019-03 | 0 | 4.43 |
| 2019-04 | 0 | 3.67 |
| 2019-05 | 0 | 5.83 |
| 2019-06 | 0 | 1.75 |
| 2019-07 | 0 | 4.17 |
| 2019-08 | 0 | 5 |
| 2019-09 | 0 | 2.57 |
| 2019-10 | 0 | 4.22 |
| 2019-11 | 0 | 4.25 |
| 2019-12 | 0 | 2.5 |
| 2020-01 | 0 | 2.78 |
| 2020-02 | 0 | 3.2 |
| 2020-03 | 0 | 2.43 |
| 2020-04 | 0 | 2.17 |
| 2020-05 | 0 | 3.33 |
| 2020-06 | 0 | 2.5 |
| 2020-07 | 0 | 2.71 |
| 2020-08 | 0 | 3.5 |
| 2020-09 | 0 | 4.86 |
| 2020-10 | 0 | 2.83 |
| 2020-11 | 0 | 3.6 |
| 2020-12 | 0 | 8 |
| 2021-01 | 0 | 2.67 |
| 2021-02 | 0 | 4 |
| 2021-03 | 0 | 8.2 |
| 2021-04 | 0 | 6.5 |
| 2021-05 | 0 | 7.8 |
| 2021-06 | 0 | 8 |
| 2021-07 | 0 | 4.83 |
| 2021-08 | 0 | 8.67 |
| 2021-09 | 0 | 3.71 |
| 2021-10 | 0 | 4 |
| 2021-11 | 0 | 13 |
| 2021-12 | 0 | 13.75 |
| 2022-01 | 0 | 4.33 |
| 2022-02 | 0 | 2.17 |
| 2022-03 | 0 | 5.83 |
| 2022-04 | 0 | 2.25 |
| 2022-05 | 0 | 2.5 |
| 2022-06 | 0 | 3.43 |
| 2022-07 | 0 | 5.5 |
| 2022-08 | 0 | 7.75 |
| 2022-09 | 0 | 3.4 |
| 2022-10 | 0 | 5.43 |
| 2022-11 | 0 | 4.63 |
| 2022-12 | 0 | 11.2 |
| 2023-01 | 0 | 5.83 |
| 2023-02 | 0 | 3.71 |
| 2023-03 | 0 | 5.57 |
| 2023-04 | 0 | 7.2 |
| 2023-05 | 0 | 5.6 |
| 2023-06 | 5 | 6.17 |
| 2023-07 | 0 | 5.75 |
| 2023-08 | 10 | 6 |
| 2023-09 | 2 | 3.22 |
| 2023-10 | 0 | 4 |
| 2023-11 | 3 | 5.44 |
| 2023-12 | 0 | 7 |
| 2024-01 | 2 | 4.22 |
| 2024-02 | 0 | 12.75 |
| 2024-03 | 0 | 6.17 |
| 2024-04 | 7 | 3.8 |
| 2024-05 | 33 | 10.5 |
| 2024-06 | 5 | 3.71 |
| 2024-07 | 0 | 2.75 |
| 2024-08 | 0 | 2.33 |
| 2024-09 | 3 | 5.67 |
| 2024-10 | 5 | 3.8 |
| 2024-11 | 3 | 5.5 |
| 2024-12 | 0 | 3 |
| 2025-01 | 0 | 4.56 |
| 2025-02 | 0 | 4.67 |
| 2025-03 | 3 | 6.33 |
| 2025-04 | 3 | 5.14 |
| 2025-05 | 0 | 7.25 |
| 2025-06 | 5 | 6.14 |
| 2025-07 | 8 | 3 |
| 2025-08 | 0 | 9 |
| 2025-09 | 3 | 4.17 |
| 2025-10 | 5 | 4 |
| 2025-11 | 3 | 3 |
| 2025-12 | 2 | 5.33 |
| 2026-01 | 0 | 5.5 |
| 2026-02 | 0 | 4.4 |
| 2026-03 | 0 | 11 |
| 2026-04 | 0 | 4.5 |
| 2026-05 | 3 | 2.33 |
| 2026-06 | 0 | 8.5 |
Failure-mode summaryAI-generated
40 linked report narratives available — no AI summary generated yet.
Recall history
| Initiated | Recall # | Class | Status | Reason | Quantity | Link basis |
|---|---|---|---|---|---|---|
| 2025-03-20 | Z-1584-2025 | Class II | Open, Classified | Due to evaporator gasket not sealing which can cause liquid nitrous oxide to drip/leak from the bottom of the device handle during treatment or after treatment during venting of the deviceDistribution: U.S Nationwide distribution in the states of AL, AZ, CA, CO, CT, DE, FL, GA, IL, IN, KY, LA, MD, MO, NC, NY, OH, PA, PR, RI, TN, TX. | 281 | code info di |
| 2024-05-03 | Z-1889-2024 | Class II | Open, Classified | Error code 003 was not listed in certain rows of the Device Instructions for Use Troubleshooting section (i.e., Table 22. Summary of LCD Messages and Error Codes).Distribution: Worldwide - US Nationwide distribution including in the states of Alabama, Arizona, Arkansas, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New York, North Carolina, Ohio, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Wisconsin and the country of Netherlands. | 1772 | code info di |
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2026-05-13 | 3012018285-2026-00001 | Injury | Available | exact di |
| 2025-12-24 | 3012018285-2025-00011 | Injury | Available | model number |
| 2025-11-26 | 3012018285-2025-00010 | Malfunction | Available | exact di |
| 2025-10-28 | 3012018285-2025-00009 | Injury | Available | exact di |
| 2025-10-02 | 3012018285-2025-00008 | Injury | Available | model number |
| 2025-09-05 | 3012018285-2025-00007 | Malfunction | Available | exact di |
| 2025-07-31 | 3012018285-2025-00006 | Malfunction | Available | exact di |
| 2025-07-14 | 3012018285-2025-00005 | Injury | Available | model number |
| 2025-07-10 | 3012018285-2025-00004 | Injury | Available | exact di |
| 2025-06-07 | 3012018285-2025-00003 | Malfunction | Available | exact di |
| 2025-06-02 | 22122313 | Malfunction | Available | model number |
| 2025-04-21 | 3012018285-2025-00002 | Malfunction | Available | exact di |
| 2025-03-07 | 3012018285-2025-00001 | Malfunction | Available | exact di |
| 2024-11-21 | 3012018285-2024-00024 | Malfunction | Available | exact di |
| 2024-10-15 | 3012018285-2024-00023 | Malfunction | Available | exact di |
Showing the most recent 43 of 113 linked reports.
Showing 1–15 of 43
Regulatory clearances
- PMAP180032Approved (APPR) · 2025-12-18 · +19 earlier decisionsclearance family
Manufacturer compliance record
| Date | Type | Outcome | Facility | Citations |
|---|---|---|---|---|
| 2019-02-01 | NAI | No action indicated | Channel Medsystems, Inc. | 0 |
| 2019-02-01 | NAI | No action indicated | Channel Medsystems, Inc. | 0 |
| 2018-10-04 | VAI | Voluntary action indicated | Channel Medsystems Inc. | 0 |
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