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.
13 linked reportsInjury 8Malfunction 5
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-11 | 0 | 1 |
| 2021-07 | 0 | 1 |
| 2021-10 | 1 | 1 |
| 2022-02 | 0 | 1 |
| 2022-03 | 1 | 1 |
| 2022-06 | 0 | 1 |
| 2022-08 | 2 | 2 |
| 2022-12 | 1 | 1 |
| 2023-02 | 0 | 2 |
| 2023-03 | 0 | 1 |
| 2024-01 | 0 | 2 |
| 2024-02 | 2 | 2 |
| 2024-03 | 2 | 2 |
| 2024-04 | 0 | 1 |
| 2024-08 | 0 | 1 |
| 2024-10 | 0 | 1 |
| 2025-01 | 1 | 1 |
| 2025-05 | 0 | 10 |
| 2025-07 | 0 | 2 |
| 2025-09 | 1 | 1 |
| 2026-01 | 2 | 2 |
| 2026-04 | 0 | 4 |
Failure-mode summaryAI-generated
13 linked report narratives available — no AI summary generated yet.
Recall history
| Initiated | Recall # | Class | Status | Reason | Quantity | Link basis |
|---|---|---|---|---|---|---|
| 2022-09-16 | Z-0078-2023 | Class II | Open, Classified | Update to the Instruction for Use (IFU): Olympus is adding a new warning against the use of accessories which are not listed in the IFU. There have been reported adverse events involving the use of collection canisters which were not designed for use with the VC-10, which can lead to serious injuries as it does not fit properly with the VC-10.Distribution: Domestic distribution nationwide. Foreign distribution to Canada and Japan. | 4184 US; 191 OUS | code info di |
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2026-01-27 | 3011050570-2026-00095 | Malfunction | Available | exact di |
| 2025-09-30 | 3011050570-2025-01116 | Malfunction | Available | model number |
| 2025-01-02 | 3011050570-2025-00001 | Malfunction | Available | model number |
| 2024-03-05 | 3011050570-2024-00092 | Injury | Available | exact di |
| 2024-02-14 | 3011050570-2024-00067 | Injury | Available | exact di |
| 2022-12-19 | 1519132-2022-00022 | Injury | Available | exact di |
| 2022-08-05 | 1519132-2022-00015 | Injury | Available | exact di |
| 2022-08-05 | 1519132-2022-00016 | Injury | Available | exact di |
| 2022-03-10 | 3003790304-2022-00036 | Malfunction | Available | exact di |
| 2021-10-22 | 1519132-2021-00018 | Injury | Available | exact di |
Showing the most recent 10 of 13 linked reports.
Regulatory clearances
None linked.
Manufacturer compliance record
| Date | Type | Outcome | Facility | Citations |
|---|---|---|---|---|
| 2023-11-02 | VAI | Voluntary action indicated | Gyrus ACMI, Inc. | 3 |
| 2022-05-02 | NAI | No action indicated | Gyrus ACMI, Inc. | 0 |
| 2020-01-14 | NAI | No action indicated | Gyrus ACMI, Inc. | 0 |
| 2018-05-23 | NAI | No action indicated | Gyrus ACMI, Inc. | 0 |
| 2018-04-17 | VAI | Voluntary action indicated | Gyrus ACMI, Inc. | 1 |
| 2017-07-27 | NAI | No action indicated | Gyrus ACMI, Inc. | 0 |
| 2016-08-17 | NAI | No action indicated | Gyrus ACMI, Inc. | 0 |
| 2016-07-01 | NAI | No action indicated | Gyrus ACMI, Inc. | 0 |
| 2015-12-11 | NAI | No action indicated | Gyrus ACMI, Inc. | 0 |
| 2015-04-03 | VAI | Voluntary action indicated | Gyrus ACMI, Inc. | 1 |
| 2015-03-20 | NAI | No action indicated | Gyrus ACMI, Inc. | 0 |
| 2013-09-18 | VAI | Voluntary action indicated | Gyrus ACMI, Inc. | 4 |
| 2013-06-21 | VAI | Voluntary action indicated | Gyrus ACMI, Inc. | 1 |
| 2013-06-11 | VAI | Voluntary action indicated | Gyrus Acmi, Inc. | 2 |
| 2012-08-31 | NAI | No action indicated | Gyrus ACMI, Inc. | 0 |
| 2012-06-14 | VAI | Voluntary action indicated | Gyrus ACMI, Inc. | 2 |
| 2011-06-13 | NAI | No action indicated | Gyrus ACMI, Inc. | 0 |
| 2010-09-15 | NAI | No action indicated | Gyrus ACMI, Inc. | 0 |
| 2010-06-24 | NAI | No action indicated | Gyrus Acmi, Inc. | 0 |
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