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) |
|---|---|---|
| 2019-02 | 0 | 2 |
| 2019-04 | 0 | 2 |
| 2019-08 | 0 | 2 |
| 2020-05 | 0 | 2 |
| 2020-07 | 0 | 4 |
| 2020-12 | 0 | 3 |
| 2021-01 | 0 | 1.5 |
| 2021-02 | 0 | 2 |
| 2021-03 | 0 | 14 |
| 2021-04 | 0 | 3 |
| 2021-09 | 0 | 1.67 |
| 2021-11 | 0 | 3 |
| 2022-04 | 0 | 3 |
| 2022-09 | 0 | 3 |
| 2022-10 | 0 | 3 |
| 2023-02 | 0 | 1 |
| 2023-06 | 0 | 1 |
| 2023-11 | 0 | 2 |
| 2024-01 | 0 | 1 |
| 2024-04 | 0 | 1 |
| 2024-08 | 0 | 1 |
| 2025-01 | 0 | 1 |
| 2025-03 | 0 | 1 |
| 2025-12 | 0 | 1 |
| 2026-05 | 1 | 1 |
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 |
|---|---|---|---|---|
| 2026-05-14 | 3002750084-2026-00045 | Malfunction | Available | exact di |
Regulatory clearances
None linked.
Manufacturer compliance record
| Date | Type | Outcome | Facility | Citations |
|---|---|---|---|---|
| 2017-11-08 | VAI | Voluntary action indicated | Aspen Surgical Products, Inc. | 5 |
| 2017-11-08 | VAI | Voluntary action indicated | Aspen Surgical Products, Inc. | 5 |
| 2017-03-02 | NAI | No action indicated | Aspen Surgical Products Inc | 0 |
| 2015-11-03 | NAI | No action indicated | Aspen Surgical Puerto Rico Corp. | 0 |
| 2015-02-11 | NAI | No action indicated | Aspen Surgical Products, Inc. | 0 |
| 2015-02-11 | NAI | No action indicated | Aspen Surgical Products, Inc. | 0 |
| 2014-07-01 | NAI | No action indicated | Aspen Surgical Products Inc | 0 |
| 2013-02-15 | VAI | Voluntary action indicated | Aspen Surgical Products, Inc. | 1 |
| 2013-02-15 | VAI | Voluntary action indicated | Aspen Surgical Products, Inc. | 1 |
| 2012-09-28 | NAI | No action indicated | Aspen Surgical Products Inc | 0 |
| 2010-02-26 | VAI | Voluntary action indicated | Aspen Surgical Products, Inc. | 4 |
| 2010-02-26 | VAI | Voluntary action indicated | Aspen Surgical Products, Inc. | 4 |
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