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.
21 linked reportsMalfunction 21
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 0 | 2 |
| 2019-02 | 0 | 1.4 |
| 2019-03 | 0 | 1.86 |
| 2019-04 | 1 | 1.63 |
| 2019-05 | 0 | 2.9 |
| 2019-06 | 0 | 1.5 |
| 2019-07 | 0 | 2.8 |
| 2019-08 | 0 | 3 |
| 2019-09 | 1 | 4.17 |
| 2019-10 | 0 | 6 |
| 2019-11 | 0 | 3.5 |
| 2019-12 | 0 | 1.88 |
| 2020-01 | 0 | 2 |
| 2020-02 | 0 | 2.29 |
| 2020-03 | 0 | 2.4 |
| 2020-04 | 1 | 1 |
| 2020-05 | 2 | 2 |
| 2020-06 | 0 | 2 |
| 2020-07 | 0 | 1.25 |
| 2020-08 | 0 | 2.67 |
| 2020-09 | 0 | 1 |
| 2020-10 | 4 | 3 |
| 2020-11 | 0 | 2.88 |
| 2020-12 | 0 | 1.5 |
| 2021-01 | 0 | 2.67 |
| 2021-02 | 0 | 4.2 |
| 2021-03 | 0 | 3.86 |
| 2021-04 | 1 | 4 |
| 2021-05 | 2 | 7.71 |
| 2021-06 | 0 | 5.25 |
| 2021-07 | 0 | 5.25 |
| 2021-08 | 0 | 3.83 |
| 2021-09 | 0 | 5 |
| 2021-10 | 0 | 15.33 |
| 2021-11 | 0 | 5.67 |
| 2021-12 | 0 | 9.29 |
| 2022-01 | 0 | 2.5 |
| 2022-02 | 0 | 5.25 |
| 2022-03 | 0 | 6.2 |
| 2022-04 | 0 | 4.33 |
| 2022-05 | 0 | 7.71 |
| 2022-06 | 0 | 12.8 |
| 2022-07 | 0 | 7.83 |
| 2022-08 | 0 | 8.67 |
| 2022-09 | 0 | 3.63 |
| 2022-10 | 0 | 8.8 |
| 2022-11 | 0 | 9.6 |
| 2022-12 | 6 | 4.75 |
| 2023-01 | 1 | 6.4 |
| 2023-02 | 0 | 7.57 |
| 2023-03 | 0 | 5.56 |
| 2023-04 | 0 | 3.5 |
| 2023-05 | 0 | 6.63 |
| 2023-06 | 0 | 5.5 |
| 2023-07 | 0 | 3.43 |
| 2023-08 | 0 | 6 |
| 2023-09 | 0 | 3.67 |
| 2023-10 | 0 | 5.14 |
| 2023-11 | 0 | 3.17 |
| 2023-12 | 0 | 3.67 |
| 2024-01 | 0 | 3.83 |
| 2024-02 | 0 | 2.67 |
| 2024-03 | 0 | 2.6 |
| 2024-04 | 2 | 4.57 |
| 2024-05 | 0 | 3.8 |
| 2024-06 | 0 | 2.5 |
| 2024-07 | 0 | 3.5 |
| 2024-08 | 0 | 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 | 0 | 5.2 |
| 2025-05 | 0 | 4.75 |
| 2025-06 | 0 | 1.6 |
| 2025-07 | 0 | 3.5 |
| 2025-08 | 0 | 3 |
| 2025-09 | 0 | 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
21 linked report narratives available — no AI summary generated yet.
Recall history
| Initiated | Recall # | Class | Status | Reason | Quantity | Link basis |
|---|---|---|---|---|---|---|
| 2022-05-25 | Z-1612-2022 | Class II | Open, Classified | Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.Distribution: US Nationwide | 5 each | clearance family |
| 2018-03-12 | Z-1879-2018 | Class II | Terminated | Products have been packaged with an incorrect product size.Distribution: CA, SC, WI, MI, NH, MD, OH, NJ, Australia, France, Spain | 500 | clearance family |
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2024-04-09 | 1216677-2021-00232 | Malfunction | Available | exact di |
| 2023-01-02 | 1216677-2022-00337 | Malfunction | Available | model number |
| 2022-12-30 | 1216677-2022-00333 | Malfunction | Available | model number |
| 2022-12-30 | 1216677-2022-00336 | Malfunction | Available | model number |
| 2022-12-30 | 1216677-2022-00332 | Malfunction | Available | model number |
| 2022-12-30 | 1216677-2022-00330 | Malfunction | Available | model number |
| 2022-12-30 | 1216677-2022-00334 | Malfunction | Available | model number |
| 2022-12-29 | 1216677-2022-00331 | Malfunction | Available | model number |
| 2021-05-21 | 1216677-2021-00115 | Malfunction | Available | exact di |
| 2021-04-21 | 11700335 | Malfunction | Available | model number |
| 2020-10-21 | 1216677-2020-00226 | Malfunction | Available | exact di |
| 2020-10-16 | 1216677-2020-00224 | Malfunction | Available | exact di |
| 2020-05-14 | 1216677-2020-00119 | Malfunction | Available | exact di |
| 2020-04-09 | MW5094096 | Malfunction | Available | exact di |
| 2019-09-10 | 1216677-2019-00252 | Malfunction | Available | model number |
Showing the most recent 16 of 21 linked reports.
Showing 1–15 of 16
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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