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.
119 linked reportsMalfunction 112Injury 7
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 4 | 21.43 |
| 2019-02 | 3 | 18.76 |
| 2019-03 | 3 | 17.38 |
| 2019-04 | 1 | 19.33 |
| 2019-05 | 5 | 13.96 |
| 2019-06 | 4 | 13.78 |
| 2019-07 | 5 | 13.72 |
| 2019-08 | 6 | 17.95 |
| 2019-09 | 2 | 18.36 |
| 2019-10 | 5 | 18.02 |
| 2019-11 | 4 | 15.86 |
| 2019-12 | 5 | 17.13 |
| 2020-01 | 4 | 16.71 |
| 2020-02 | 3 | 20.62 |
| 2020-03 | 6 | 18.02 |
| 2020-04 | 4 | 17.91 |
| 2020-05 | 3 | 18.04 |
| 2020-06 | 5 | 23 |
| 2020-07 | 3 | 18.62 |
| 2020-08 | 4 | 16.63 |
| 2020-09 | 1 | 17.67 |
| 2020-10 | 0 | 14.94 |
| 2020-11 | 0 | 24.82 |
| 2020-12 | 4 | 22.21 |
| 2021-01 | 2 | 15.96 |
| 2021-02 | 2 | 16.49 |
| 2021-03 | 6 | 19.12 |
| 2021-04 | 2 | 15.19 |
| 2021-05 | 4 | 15.95 |
| 2021-06 | 0 | 19 |
| 2021-07 | 1 | 16.37 |
| 2021-08 | 0 | 18 |
| 2021-09 | 2 | 23.38 |
| 2021-10 | 0 | 22.3 |
| 2021-11 | 0 | 22.43 |
| 2021-12 | 1 | 30.38 |
| 2022-01 | 1 | 17.63 |
| 2022-02 | 0 | 20.54 |
| 2022-03 | 1 | 24.04 |
| 2022-04 | 0 | 20.64 |
| 2022-05 | 0 | 19.24 |
| 2022-06 | 0 | 25.56 |
| 2022-07 | 0 | 14.88 |
| 2022-08 | 3 | 22.97 |
| 2022-09 | 0 | 23.4 |
| 2022-10 | 1 | 24.15 |
| 2022-11 | 1 | 27.41 |
| 2022-12 | 1 | 24.35 |
| 2023-01 | 2 | 25.31 |
| 2023-02 | 1 | 18 |
| 2023-03 | 1 | 17.71 |
| 2023-04 | 0 | 24.73 |
| 2023-05 | 1 | 20.82 |
| 2023-06 | 0 | 21.58 |
| 2023-07 | 0 | 19.96 |
| 2023-08 | 0 | 18.26 |
| 2023-09 | 0 | 17.14 |
| 2023-10 | 0 | 20.16 |
| 2023-11 | 0 | 16.89 |
| 2023-12 | 0 | 23.32 |
| 2024-01 | 0 | 18.64 |
| 2024-02 | 1 | 16.59 |
| 2024-03 | 0 | 13.58 |
| 2024-04 | 0 | 14.97 |
| 2024-05 | 0 | 12.78 |
| 2024-06 | 0 | 18.13 |
| 2024-07 | 0 | 13.33 |
| 2024-08 | 0 | 15.55 |
| 2024-09 | 0 | 17.28 |
| 2024-10 | 0 | 12.35 |
| 2024-11 | 0 | 11.41 |
| 2024-12 | 0 | 16.73 |
| 2025-01 | 1 | 13.56 |
| 2025-02 | 0 | 13.63 |
| 2025-03 | 0 | 12.54 |
| 2025-04 | 0 | 11.36 |
| 2025-05 | 0 | 16.95 |
| 2025-06 | 0 | 13.06 |
| 2025-07 | 0 | 18 |
| 2025-08 | 0 | 17.47 |
| 2025-09 | 0 | 14.61 |
| 2025-10 | 0 | 11.11 |
| 2025-11 | 0 | 10.08 |
| 2025-12 | 0 | 16.79 |
| 2026-01 | 0 | 14.68 |
| 2026-02 | 0 | 15.06 |
| 2026-03 | 0 | 11.26 |
| 2026-04 | 0 | 12.27 |
| 2026-05 | 0 | 12.42 |
| 2026-06 | 0 | 16.46 |
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 |
|---|---|---|---|---|
| 2025-01-10 | 1717344-2025-00070 | Malfunction | Available | exact di |
| 2024-02-20 | 1717344-2024-00486 | Malfunction | Available | exact di |
| 2023-05-15 | 1717344-2023-00581 | Malfunction | Available | exact di |
| 2023-03-27 | 1717344-2023-00381 | Malfunction | Available | exact di |
| 2023-02-28 | 1717344-2023-00254 | Malfunction | Available | exact di |
| 2023-01-06 | 1717344-2023-00040 | Injury | Available | exact di |
| 2023-01-03 | 1717344-2023-00003 | Malfunction | Available | exact di |
| 2022-12-20 | 1717344-2022-01562 | Malfunction | Available | exact di |
| 2022-11-08 | 1717344-2022-01378 | Malfunction | Available | exact di |
| 2022-10-06 | 1717344-2022-01252 | Malfunction | Available | exact di |
| 2022-08-30 | 1717344-2022-01046 | Malfunction | Available | exact di |
| 2022-08-26 | 1717344-2022-01035 | Malfunction | Available | exact di |
| 2022-08-26 | 1717344-2022-01031 | Malfunction | Available | exact di |
| 2022-03-07 | 1717344-2022-00259 | Malfunction | Available | exact di |
| 2022-01-28 | 1717344-2022-00104 | Malfunction | Available | exact di |
Showing 1–15 of 119
Regulatory clearances
- 510(k)K101797Substantially equivalent (SESE) · 2011-02-24clearance family
Predicate lineage
Cited as predicate by: K141371, K143562, K151359, K151511, K153371, K170955, K173627, K180149, K200427
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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