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.
32 linked reportsMalfunction 28Injury 4
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 0 | 2 |
| 2019-02 | 0 | 4 |
| 2019-03 | 0 | 3 |
| 2019-04 | 0 | 6.5 |
| 2019-05 | 0 | 2.33 |
| 2019-06 | 4 | 4.25 |
| 2019-07 | 2 | 2 |
| 2019-08 | 1 | 2 |
| 2019-09 | 6 | 4 |
| 2019-10 | 4 | 2.4 |
| 2019-11 | 0 | 2 |
| 2019-12 | 0 | 1.8 |
| 2020-01 | 0 | 1.5 |
| 2020-02 | 2 | 1.5 |
| 2020-03 | 0 | 2.33 |
| 2020-04 | 0 | 2 |
| 2020-05 | 0 | 1.33 |
| 2020-07 | 0 | 2 |
| 2020-08 | 0 | 1.67 |
| 2020-09 | 0 | 1.5 |
| 2020-10 | 0 | 2.2 |
| 2020-11 | 0 | 1 |
| 2020-12 | 0 | 2 |
| 2021-02 | 0 | 7 |
| 2021-03 | 0 | 6.67 |
| 2021-04 | 5 | 3 |
| 2021-05 | 0 | 2.5 |
| 2021-06 | 0 | 12.25 |
| 2021-07 | 0 | 22.5 |
| 2021-08 | 0 | 16.5 |
| 2021-09 | 0 | 8.5 |
| 2021-10 | 0 | 30 |
| 2021-11 | 0 | 22 |
| 2021-12 | 0 | 11.75 |
| 2022-01 | 0 | 12.67 |
| 2022-02 | 0 | 9 |
| 2022-03 | 0 | 34 |
| 2022-04 | 0 | 3.25 |
| 2022-05 | 0 | 3 |
| 2022-06 | 0 | 1.67 |
| 2022-07 | 0 | 3 |
| 2022-08 | 0 | 2 |
| 2022-09 | 0 | 4 |
| 2022-10 | 0 | 2 |
| 2022-11 | 0 | 2 |
| 2022-12 | 2 | 2 |
| 2023-02 | 0 | 2.67 |
| 2023-03 | 0 | 3 |
| 2023-04 | 0 | 2 |
| 2023-05 | 0 | 2.33 |
| 2023-06 | 4 | 2.5 |
| 2023-07 | 0 | 3 |
| 2023-08 | 0 | 1.67 |
| 2023-09 | 0 | 2.75 |
| 2023-10 | 0 | 2 |
| 2023-11 | 0 | 3 |
| 2023-12 | 0 | 2.33 |
| 2024-01 | 0 | 3.5 |
| 2024-02 | 0 | 3.5 |
| 2024-03 | 0 | 2 |
| 2024-04 | 0 | 3.25 |
| 2024-05 | 0 | 2 |
| 2024-06 | 0 | 2.33 |
| 2024-07 | 0 | 3.5 |
| 2024-08 | 0 | 1.67 |
| 2024-09 | 0 | 1.5 |
| 2024-10 | 0 | 5 |
| 2024-11 | 0 | 6.67 |
| 2024-12 | 0 | 4 |
| 2025-01 | 0 | 1.6 |
| 2025-02 | 0 | 3.5 |
| 2025-03 | 0 | 3 |
| 2025-04 | 0 | 1 |
| 2025-05 | 0 | 3 |
| 2025-06 | 0 | 1.8 |
| 2025-07 | 0 | 5 |
| 2025-09 | 0 | 1.5 |
| 2025-10 | 2 | 2.83 |
| 2025-11 | 0 | 3 |
| 2025-12 | 0 | 2 |
| 2026-01 | 0 | 2 |
| 2026-02 | 0 | 2.5 |
| 2026-03 | 0 | 3.2 |
| 2026-04 | 0 | 2 |
| 2026-05 | 0 | 1.25 |
| 2026-06 | 0 | 3.83 |
Failure-mode summaryAI-generated
32 linked report narratives available — no AI summary generated yet.
Recall history
| Initiated | Recall # | Class | Status | Reason | Quantity | Link basis |
|---|---|---|---|---|---|---|
| 2023-07-17 | Z-2629-2023 | Class II | Open, Classified | The display of inflow volume can reach its limit of 30,000 ml during long procdeure and the inflow volume display will freeze at the maximum value while the deficit will start counting backwards until 0 ml is reached and may result in fluid overloadDistribution: Nationwide Foreign: Canada, Australia, New Zealand, Belgium, France, Germany, Ireland, Netherlands, Spain, Sweden, Norway, Switzerland, UK, Kuwait, Qatar, Turkey, UAE | 1287 units | clearance family |
| 2019-08-14 | Z-2767-2019 | Class II | Terminated | The deficit displayed by the pump can differ from the real deficit, leading potentially to patient risk.Distribution: US Nationwide Distribution | 322 units | code info di |
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2025-10-28 | 3002914049-2025-00004 | Malfunction | Available | exact di |
| 2023-06-08 | 3002914049-2023-00005 | Malfunction | Available | exact di |
| 2023-06-07 | 3002914049-2023-00004 | Injury | Available | exact di |
| 2022-12-16 | 3002914049-2022-00012 | Malfunction | Available | exact di |
| 2021-04-06 | 3002914049-2021-00005 | Malfunction | Available | exact di |
| 2021-04-06 | 3002914049-2021-00002 | Malfunction | Available | exact di |
| 2021-04-06 | 3002914049-2021-00004 | Malfunction | Available | exact di |
| 2020-02-14 | 3002914049-2020-00002 | Malfunction | Available | exact di |
| 2019-10-18 | 3002914049-2019-00015 | Malfunction | Available | exact di |
| 2019-10-11 | 3002914049-2019-00013 | Injury | Available | exact di |
| 2019-09-17 | 3002914049-2019-00011 | Malfunction | Available | exact di |
| 2019-09-17 | 3002914049-2019-00012 | Malfunction | Available | exact di |
| 2019-09-17 | 3002914049-2019-00010 | Malfunction | Available | exact di |
| 2019-08-07 | 3002914049-2019-00008 | Malfunction | Available | exact di |
| 2019-07-08 | 3002914049-2019-00007 | Malfunction | Available | exact di |
Showing the most recent 17 of 32 linked reports.
Showing 1–15 of 17
Regulatory clearances
- 510(k)K172040Substantially equivalent (SESE) · 2018-02-05clearance family
Manufacturer compliance record
None in the loaded window.
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