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.
1 linked reportMalfunction 1
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-06 | 1 | 1 |
| 2019-07 | 0 | 1 |
| 2020-11 | 0 | 1 |
| 2020-12 | 0 | 1 |
| 2021-03 | 0 | 1 |
| 2021-04 | 0 | 2 |
| 2021-10 | 0 | 1 |
| 2022-01 | 0 | 1 |
| 2022-02 | 0 | 1 |
| 2022-03 | 0 | 3 |
| 2022-06 | 0 | 1 |
| 2023-01 | 0 | 1 |
| 2023-03 | 0 | 2 |
| 2023-04 | 0 | 2 |
| 2024-04 | 0 | 1 |
| 2025-11 | 0 | 1 |
| 2025-12 | 0 | 1 |
| 2026-01 | 0 | 1 |
| 2026-02 | 0 | 1.5 |
| 2026-03 | 0 | 1.5 |
| 2026-04 | 0 | 2 |
| 2026-05 | 0 | 2 |
Failure-mode summaryAI-generated
1 linked report narrative available — no AI summary generated yet.
Recall history
No recalls linked.
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2019-06-17 | 1421101-2019-00001 | Malfunction | Available | exact di |
Regulatory clearances
None linked.
Manufacturer compliance record
| Date | Type | Outcome | Facility | Citations |
|---|---|---|---|---|
| 2023-12-05 | VAI | Voluntary action indicated | Instrumed International Inc | 5 |
| 2022-06-28 | VAI | Voluntary action indicated | Avalign Integrated Medical Solutions, Inc. | 3 |
| 2019-11-20 | VAI | Voluntary action indicated | Instrumed International Inc | 2 |
| 2018-10-25 | NAI | No action indicated | Instrumed GmbH | 0 |
| 2016-11-30 | NAI | No action indicated | Instrumed International Inc | 0 |
| 2015-09-22 | NAI | No action indicated | Millennium Surgical Corp | 0 |
| 2015-01-29 | NAI | No action indicated | Instrumed GmbH | 0 |
| 2014-03-28 | WL | Warning Letter | Instrumed GmbH | — |
| 2013-08-20 | VAI | Voluntary action indicated | Instrumed International Inc | 17 |
| 2013-08-01 | OAI | Official action indicated | Instrumed GmbH | 0 |
| 2013-04-24 | VAI | Voluntary action indicated | Avalign Integrated Medical Solutions, Inc. | 4 |
| 2011-02-28 | NAI | No action indicated | Instrumed International Inc | 0 |
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