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.
95 linked reportsMalfunction 95
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 0 | 4 |
| 2019-02 | 0 | 1.25 |
| 2019-03 | 0 | 1.8 |
| 2019-04 | 1 | 2 |
| 2019-05 | 3 | 1.75 |
| 2019-06 | 1 | 1.5 |
| 2019-07 | 2 | 2.24 |
| 2019-08 | 2 | 1.89 |
| 2019-09 | 2 | 2.38 |
| 2019-10 | 1 | 2.46 |
| 2019-11 | 4 | 4.11 |
| 2019-12 | 2 | 3 |
| 2020-01 | 0 | 3 |
| 2020-02 | 0 | 5 |
| 2020-03 | 1 | 2.85 |
| 2020-04 | 0 | 4.25 |
| 2020-05 | 0 | 2.5 |
| 2020-06 | 0 | 2.75 |
| 2020-07 | 1 | 2.38 |
| 2020-08 | 2 | 2.82 |
| 2020-09 | 0 | 3.14 |
| 2020-10 | 1 | 1.25 |
| 2020-11 | 0 | 5 |
| 2020-12 | 1 | 1.22 |
| 2021-01 | 0 | 1.8 |
| 2021-02 | 2 | 5 |
| 2021-03 | 0 | 2.38 |
| 2021-04 | 1 | 1.9 |
| 2021-05 | 1 | 2.13 |
| 2021-06 | 1 | 2.25 |
| 2021-07 | 2 | 2 |
| 2021-08 | 5 | 2.8 |
| 2021-09 | 2 | 1.86 |
| 2021-10 | 0 | 1.33 |
| 2021-11 | 3 | 3.33 |
| 2021-12 | 0 | 2.67 |
| 2022-01 | 5 | 2.36 |
| 2022-02 | 0 | 1.25 |
| 2022-03 | 2 | 2 |
| 2022-04 | 4 | 1.77 |
| 2022-05 | 2 | 1.75 |
| 2022-06 | 5 | 2 |
| 2022-07 | 4 | 2.1 |
| 2022-08 | 5 | 3.57 |
| 2022-09 | 4 | 2.11 |
| 2022-10 | 5 | 2.1 |
| 2022-11 | 5 | 2.4 |
| 2022-12 | 0 | 1.43 |
| 2023-01 | 1 | 2.14 |
| 2023-02 | 1 | 1.3 |
| 2023-03 | 3 | 2.38 |
| 2023-04 | 2 | 1.7 |
| 2023-05 | 0 | 1.25 |
| 2023-06 | 0 | 1.29 |
| 2023-07 | 2 | 1.57 |
| 2023-08 | 4 | 3.2 |
| 2023-09 | 0 | 1.71 |
| 2023-10 | 0 | 1.45 |
| 2023-11 | 0 | 3 |
| 2023-12 | 0 | 1 |
| 2024-01 | 0 | 1.25 |
| 2024-02 | 0 | 1.44 |
| 2024-03 | 0 | 1.43 |
| 2024-04 | 0 | 1 |
| 2024-05 | 0 | 1 |
| 2024-06 | 0 | 1.4 |
| 2024-07 | 0 | 1.4 |
| 2024-08 | 0 | 1.33 |
| 2024-09 | 0 | 1.67 |
| 2024-10 | 0 | 2.17 |
| 2024-11 | 0 | 2 |
| 2024-12 | 0 | 2.5 |
| 2025-01 | 0 | 1.43 |
| 2025-02 | 0 | 1.33 |
| 2025-03 | 0 | 1.3 |
| 2025-04 | 0 | 1.86 |
| 2025-05 | 0 | 1.64 |
| 2025-07 | 0 | 2 |
| 2025-08 | 0 | 1.67 |
| 2025-09 | 0 | 2.2 |
| 2025-10 | 0 | 1.33 |
| 2025-11 | 0 | 1.89 |
| 2025-12 | 0 | 3.17 |
| 2026-01 | 0 | 3 |
| 2026-02 | 0 | 3 |
| 2026-03 | 0 | 2.08 |
| 2026-04 | 0 | 2.57 |
| 2026-05 | 0 | 3.17 |
| 2026-06 | 0 | 2.71 |
Failure-mode summaryAI-generated
40 linked report narratives available — no AI summary generated yet.
Recall history
No recalls linked.
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2023-08-24 | 1216677-2023-00122 | Malfunction | Available | procode brand trgm |
| 2023-08-24 | 1216677-2023-00120 | Malfunction | Available | procode brand trgm |
| 2023-08-23 | 1216677-2023-00121 | Malfunction | Available | procode brand trgm |
| 2023-08-09 | 1216677-2023-00114 | Malfunction | Available | procode brand trgm |
| 2023-07-11 | 1216677-2023-00101 | Malfunction | Available | procode brand trgm |
| 2023-07-11 | 1216677-2023-00102 | Malfunction | Available | procode brand trgm |
| 2023-04-10 | 1216677-2023-00062 | Malfunction | Available | procode brand trgm |
| 2023-04-10 | 1216677-2023-00060 | Malfunction | Available | procode brand trgm |
| 2023-03-23 | 1216677-2023-00054 | Malfunction | Available | procode brand trgm |
| 2023-03-03 | 1216677-2023-00041 | Malfunction | Available | procode brand trgm |
| 2023-03-01 | 1216677-2023-00031 | Malfunction | Available | procode brand trgm |
| 2023-02-03 | 1216677-2023-00023 | Malfunction | Available | procode brand trgm |
| 2023-01-27 | 1216677-2023-00012 | Malfunction | Available | procode brand trgm |
| 2022-11-28 | 1216677-2022-00310 | Malfunction | Available | procode brand trgm |
| 2022-11-18 | 1216677-2022-00305 | Malfunction | Available | procode brand trgm |
Showing 1–15 of 95
Regulatory clearances
Predicate lineage
K935010
Cited as predicate by: K193619
Lineage each submission cites, walked transitively (indented = the cited device's own predicates). Extracted from public 510(k) summary text — heuristic, and includes reference devices mentioned alongside true predicates.
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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