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.
14 linked reportsMalfunction 12Injury 2
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 0 | 2.65 |
| 2019-02 | 0 | 4.85 |
| 2019-03 | 0 | 4.67 |
| 2019-04 | 0 | 3.17 |
| 2019-05 | 0 | 4.17 |
| 2019-06 | 0 | 5.17 |
| 2019-07 | 0 | 4.81 |
| 2019-08 | 0 | 5.87 |
| 2019-09 | 0 | 2.97 |
| 2019-10 | 0 | 3.17 |
| 2019-11 | 0 | 3.54 |
| 2019-12 | 0 | 4.79 |
| 2020-01 | 0 | 2.53 |
| 2020-02 | 0 | 3.88 |
| 2020-03 | 0 | 4.8 |
| 2020-04 | 0 | 4.04 |
| 2020-05 | 0 | 2.48 |
| 2020-06 | 0 | 3.1 |
| 2020-07 | 0 | 4.05 |
| 2020-08 | 0 | 2.73 |
| 2020-09 | 0 | 1.97 |
| 2020-10 | 0 | 3.78 |
| 2020-11 | 0 | 3.47 |
| 2020-12 | 0 | 4.78 |
| 2021-01 | 0 | 5.15 |
| 2021-02 | 0 | 4.14 |
| 2021-03 | 0 | 5.71 |
| 2021-04 | 0 | 3.63 |
| 2021-05 | 0 | 5 |
| 2021-06 | 0 | 4.98 |
| 2021-07 | 0 | 6.52 |
| 2021-08 | 0 | 5.93 |
| 2021-09 | 0 | 7.41 |
| 2021-10 | 0 | 5.72 |
| 2021-11 | 0 | 5.41 |
| 2021-12 | 0 | 7.97 |
| 2022-01 | 0 | 5.5 |
| 2022-02 | 0 | 7.74 |
| 2022-03 | 0 | 6.18 |
| 2022-04 | 0 | 6.57 |
| 2022-05 | 0 | 7.45 |
| 2022-06 | 0 | 6.17 |
| 2022-07 | 0 | 5.91 |
| 2022-08 | 0 | 5.09 |
| 2022-09 | 0 | 4.74 |
| 2022-10 | 0 | 4.43 |
| 2022-11 | 0 | 4.38 |
| 2022-12 | 0 | 4.81 |
| 2023-01 | 0 | 5.11 |
| 2023-02 | 0 | 4.55 |
| 2023-03 | 0 | 4.97 |
| 2023-04 | 0 | 3.69 |
| 2023-05 | 0 | 5.94 |
| 2023-06 | 0 | 4 |
| 2023-07 | 0 | 4.12 |
| 2023-08 | 0 | 5.33 |
| 2023-09 | 0 | 5.39 |
| 2023-10 | 0 | 6.24 |
| 2023-11 | 0 | 4.53 |
| 2023-12 | 0 | 4.9 |
| 2024-01 | 0 | 5.69 |
| 2024-02 | 0 | 4.3 |
| 2024-03 | 0 | 5.32 |
| 2024-04 | 0 | 5.47 |
| 2024-05 | 0 | 4.08 |
| 2024-06 | 0 | 5.54 |
| 2024-07 | 0 | 4.78 |
| 2024-08 | 0 | 5.3 |
| 2024-09 | 0 | 5.27 |
| 2024-10 | 0 | 5.75 |
| 2024-11 | 0 | 3.89 |
| 2024-12 | 0 | 9.38 |
| 2025-01 | 0 | 4 |
| 2025-02 | 0 | 3.85 |
| 2025-03 | 0 | 6.11 |
| 2025-04 | 0 | 3.21 |
| 2025-05 | 0 | 4.2 |
| 2025-06 | 0 | 4.15 |
| 2025-07 | 0 | 4.17 |
| 2025-08 | 0 | 5.65 |
| 2025-09 | 0 | 6.56 |
| 2025-10 | 0 | 9.4 |
| 2025-11 | 0 | 11.48 |
| 2025-12 | 0 | 16.54 |
| 2026-01 | 0 | 10.77 |
| 2026-02 | 0 | 6.4 |
| 2026-03 | 0 | 8.18 |
| 2026-04 | 2 | 10.63 |
| 2026-05 | 6 | 15.69 |
| 2026-06 | 6 | 14.42 |
Failure-mode summaryAI-generated
14 linked report narratives available — no AI summary generated yet.
Recall history
No recalls linked.
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2026-06-19 | 1216677-2026-00053 | Malfunction | Available | exact di |
| 2026-06-19 | 1216677-2026-00054 | Malfunction | Available | exact di |
| 2026-06-17 | 1216677-2026-00049 | Malfunction | Available | exact di |
| 2026-05-29 | 1216677-2026-00042 | Malfunction | Available | exact di |
| 2026-05-29 | 1216677-2026-00040 | Malfunction | Available | exact di |
| 2026-05-29 | 1216677-2026-00041 | Malfunction | Available | exact di |
| 2026-04-29 | 1216677-2026-00036 | Injury | Available | exact di |
Showing the most recent 7 of 14 linked reports.
Regulatory clearances
- 510(k)K171272Substantially equivalent (SESE) · 2018-07-17clearance family
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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