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.
35 linked reportsMalfunction 35
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 0 | 2 |
| 2019-02 | 0 | 2 |
| 2019-03 | 2 | 1.67 |
| 2019-04 | 0 | 2 |
| 2019-05 | 0 | 1.5 |
| 2019-06 | 2 | 1.33 |
| 2019-07 | 0 | 1.5 |
| 2019-08 | 0 | 1 |
| 2019-09 | 0 | 2 |
| 2019-10 | 0 | 1 |
| 2019-11 | 6 | 3.25 |
| 2019-12 | 0 | 2 |
| 2020-01 | 0 | 2 |
| 2020-02 | 0 | 1.33 |
| 2020-03 | 4 | 4 |
| 2020-04 | 6 | 6 |
| 2020-05 | 4 | 4 |
| 2020-06 | 0 | 2 |
| 2020-07 | 0 | 2 |
| 2020-09 | 0 | 2 |
| 2020-10 | 0 | 1 |
| 2020-11 | 0 | 2 |
| 2020-12 | 0 | 2 |
| 2021-01 | 0 | 1 |
| 2021-02 | 0 | 4 |
| 2021-04 | 0 | 2 |
| 2021-05 | 4 | 3.33 |
| 2021-06 | 2 | 2 |
| 2021-07 | 2 | 2 |
| 2021-11 | 0 | 2 |
| 2021-12 | 0 | 3 |
| 2022-01 | 1 | 1 |
| 2022-04 | 0 | 2 |
| 2022-05 | 1 | 1 |
| 2022-07 | 0 | 1.33 |
| 2022-08 | 0 | 2 |
| 2022-09 | 0 | 1 |
| 2022-10 | 0 | 2 |
| 2023-02 | 0 | 2 |
| 2023-03 | 0 | 2 |
| 2023-04 | 0 | 1 |
| 2023-05 | 0 | 6 |
| 2023-06 | 0 | 2.5 |
| 2023-08 | 1 | 1 |
| 2023-11 | 0 | 2 |
| 2024-01 | 0 | 1.5 |
| 2024-02 | 0 | 6 |
| 2024-03 | 0 | 1 |
| 2024-04 | 0 | 4 |
| 2024-06 | 0 | 1.5 |
| 2024-08 | 0 | 2 |
| 2024-10 | 0 | 2 |
| 2024-11 | 0 | 3 |
| 2024-12 | 0 | 1 |
| 2025-01 | 0 | 2 |
| 2025-04 | 0 | 1 |
| 2025-06 | 0 | 1 |
| 2025-10 | 0 | 2.5 |
| 2025-11 | 0 | 2 |
| 2026-01 | 0 | 1 |
| 2026-02 | 0 | 1 |
| 2026-03 | 0 | 7.5 |
| 2026-04 | 0 | 2 |
| 2026-06 | 0 | 2 |
Failure-mode summaryAI-generated
35 linked report narratives available — no AI summary generated yet.
Recall history
No recalls linked.
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2023-08-31 | 17660832 | Malfunction | Available | model number |
| 2022-05-13 | 1216677-2022-00149 | Malfunction | Available | model number |
| 2022-01-08 | 1216677-2021-00315 | Malfunction | Available | model number |
| 2021-07-12 | 1216677-2021-00144 | Malfunction | Available | exact di |
| 2021-06-04 | 1216677-2021-00120 | Malfunction | Available | exact di |
| 2021-05-07 | 1216677-2021-00089 | Malfunction | Available | exact di |
| 2021-05-07 | 1216677-2021-00088 | Malfunction | Available | exact di |
| 2020-05-25 | 1216677-2020-00124 | Malfunction | Available | exact di |
| 2020-05-25 | 1216677-2020-00123 | Malfunction | Available | exact di |
| 2020-04-23 | 1216677-2020-00097 | Malfunction | Available | exact di |
| 2020-04-23 | 1216677-2020-00098 | Malfunction | Available | exact di |
| 2020-04-16 | 1216677-2020-00093 | Malfunction | Available | exact di |
| 2020-03-31 | 9902792 | Malfunction | Available | exact di |
| 2020-03-05 | 1216677-2020-00075 | Malfunction | Available | exact di |
| 2019-11-26 | 1216677-2019-00308 | Malfunction | Available | exact di |
Showing the most recent 20 of 35 linked reports.
Showing 1–15 of 20
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 | — |
Similar devices
- Accessories for Vario 18 pump Medela AG
- Angle piece Orange DCS Medela AG
- Angle piece yellow DCS Medela AG
- Basic portable Medela AG
- Basic rack Medela AG
- CMI UTAH MEDICAL PRODUCTS, INC.
- CMI UTAH MEDICAL PRODUCTS, INC.
- CMI UTAH MEDICAL PRODUCTS, INC.
- CMI UTAH MEDICAL PRODUCTS, INC.
- CMI UTAH MEDICAL PRODUCTS, INC.
- CMI UTAH MEDICAL PRODUCTS, INC.
- CMI UTAH MEDICAL PRODUCTS, INC.
Select up to two to place side-by-side with this device.