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.
10 linked reportsMalfunction 8Injury 2
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-07 | 0 | 6 |
| 2019-08 | 0 | 4 |
| 2019-10 | 0 | 4.33 |
| 2019-11 | 0 | 1.67 |
| 2019-12 | 0 | 2 |
| 2020-01 | 0 | 1.5 |
| 2020-02 | 0 | 1.4 |
| 2020-06 | 0 | 1.5 |
| 2020-07 | 0 | 1.5 |
| 2020-10 | 0 | 3 |
| 2020-11 | 0 | 4 |
| 2020-12 | 0 | 1 |
| 2021-01 | 0 | 1 |
| 2021-02 | 0 | 2 |
| 2021-05 | 0 | 1.5 |
| 2021-07 | 0 | 2 |
| 2021-08 | 0 | 17 |
| 2021-09 | 0 | 7.5 |
| 2021-10 | 0 | 1.33 |
| 2021-11 | 0 | 3 |
| 2021-12 | 0 | 8 |
| 2022-01 | 0 | 4 |
| 2022-03 | 0 | 5.33 |
| 2022-04 | 0 | 1 |
| 2022-05 | 0 | 4.33 |
| 2022-06 | 0 | 1.2 |
| 2022-07 | 0 | 1.25 |
| 2022-08 | 0 | 2.67 |
| 2022-09 | 0 | 2.75 |
| 2022-10 | 0 | 2.5 |
| 2022-11 | 0 | 2 |
| 2023-01 | 0 | 2.5 |
| 2023-02 | 0 | 6 |
| 2023-03 | 0 | 5 |
| 2023-05 | 0 | 6 |
| 2023-06 | 0 | 2 |
| 2023-07 | 0 | 1 |
| 2023-08 | 0 | 2 |
| 2023-09 | 0 | 1.5 |
| 2023-10 | 0 | 2 |
| 2023-11 | 0 | 4 |
| 2023-12 | 0 | 4 |
| 2024-01 | 1 | 1 |
| 2024-02 | 2 | 5.33 |
| 2024-03 | 0 | 1 |
| 2024-04 | 0 | 2 |
| 2024-05 | 0 | 5 |
| 2024-06 | 1 | 2.67 |
| 2024-07 | 0 | 4.25 |
| 2024-08 | 0 | 3.75 |
| 2024-10 | 0 | 4.67 |
| 2024-11 | 0 | 2.88 |
| 2024-12 | 0 | 1.5 |
| 2025-01 | 0 | 3.57 |
| 2025-02 | 0 | 2.25 |
| 2025-03 | 0 | 2.5 |
| 2025-04 | 0 | 3.17 |
| 2025-05 | 0 | 2.25 |
| 2025-06 | 0 | 1.33 |
| 2025-07 | 0 | 2 |
| 2025-08 | 0 | 3.5 |
| 2025-09 | 0 | 3.75 |
| 2025-10 | 0 | 1.4 |
| 2025-11 | 0 | 5.29 |
| 2025-12 | 2 | 2.11 |
| 2026-01 | 0 | 4 |
| 2026-02 | 0 | 5.5 |
| 2026-03 | 0 | 3.5 |
| 2026-04 | 0 | 3.5 |
| 2026-05 | 0 | 2.8 |
| 2026-06 | 4 | 2.83 |
Failure-mode summaryAI-generated
10 linked report narratives available — no AI summary generated yet.
Recall history
No recalls linked.
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2026-06-24 | 2936999-2026-00255 | Injury | Available | exact di |
| 2026-06-15 | 2936999-2026-00223 | Malfunction | Available | exact di |
| 2025-12-30 | 2936999-2025-00606 | Malfunction | Available | exact di |
| 2024-06-26 | 2936999-2024-00977 | Malfunction | Available | exact di |
| 2024-02-02 | 2936999-2024-00232 | Malfunction | Available | exact di |
| 2024-02-02 | 2936999-2024-00221 | Malfunction | Available | exact di |
| 2024-01-03 | 2936999-2024-00015 | Malfunction | Available | exact di |
Showing the most recent 7 of 10 linked reports.
Regulatory clearances
Predicate lineage
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 |
|---|---|---|---|---|
| 2025-07-16 | NAI | No action indicated | Covidien LLC | 0 |
| 2025-07-16 | NAI | No action indicated | Covidien LLC | 0 |
| 2024-11-21 | NAI | No action indicated | Covidien, LP | 0 |
| 2024-11-21 | NAI | No action indicated | Covidien, LP | 0 |
| 2022-11-18 | VAI | Voluntary action indicated | Covidien LP | 1 |
| 2022-11-18 | VAI | Voluntary action indicated | Covidien LP | 1 |
| 2022-09-08 | VAI | Voluntary action indicated | Covidien | 0 |
| 2022-09-08 | VAI | Voluntary action indicated | Covidien | 0 |
| 2022-04-28 | OAI | Official action indicated | Covidien | 2 |
| 2022-04-28 | OAI | Official action indicated | Covidien | 2 |
| 2020-02-28 | VAI | Voluntary action indicated | Covidien, LP | 1 |
| 2020-02-28 | VAI | Voluntary action indicated | Covidien, LP | 1 |
| 2018-09-19 | NAI | No action indicated | Covidien | 0 |
| 2018-09-19 | NAI | No action indicated | Covidien | 0 |
| 2017-09-22 | VAI | Voluntary action indicated | Covidien, LLC | 2 |
| 2017-09-22 | VAI | Voluntary action indicated | Covidien, LLC | 2 |
| 2017-08-09 | NAI | No action indicated | Covidien | 0 |
| 2017-08-09 | NAI | No action indicated | Covidien | 0 |
| 2016-10-31 | NAI | No action indicated | Covidien | 0 |
| 2016-10-31 | NAI | No action indicated | Covidien | 0 |
| 2012-06-14 | WL | Warning Letter | Covidien, LP | — |
| 2012-06-14 | WL | Warning Letter | Covidien, LP | — |
| 2011-10-04 | WL | Warning Letter | Oridion Medical 1987 Ltd. | — |
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