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.
303 linked reportsMalfunction 291Injury 12
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 5 | 13.41 |
| 2019-02 | 3 | 3.29 |
| 2019-03 | 5 | 3.78 |
| 2019-04 | 1 | 4.27 |
| 2019-05 | 0 | 4.18 |
| 2019-06 | 0 | 3.67 |
| 2019-07 | 0 | 3.38 |
| 2019-08 | 0 | 3.9 |
| 2019-09 | 8 | 4.55 |
| 2019-10 | 5 | 5.02 |
| 2019-11 | 6 | 4.63 |
| 2019-12 | 5 | 5.21 |
| 2020-01 | 9 | 5.18 |
| 2020-02 | 9 | 5.84 |
| 2020-03 | 0 | 5.61 |
| 2020-04 | 3 | 5 |
| 2020-05 | 7 | 3.51 |
| 2020-06 | 10 | 5.69 |
| 2020-07 | 3 | 6.15 |
| 2020-08 | 3 | 5.71 |
| 2020-09 | 6 | 7.49 |
| 2020-10 | 1 | 8.72 |
| 2020-11 | 0 | 5.95 |
| 2020-12 | 2 | 8.86 |
| 2021-01 | 1 | 6.31 |
| 2021-02 | 1 | 5.77 |
| 2021-03 | 2 | 7.8 |
| 2021-04 | 3 | 6.1 |
| 2021-05 | 3 | 5.63 |
| 2021-06 | 6 | 5.7 |
| 2021-07 | 0 | 4.96 |
| 2021-08 | 0 | 5.25 |
| 2021-09 | 2 | 3.47 |
| 2021-10 | 1 | 5.1 |
| 2021-11 | 2 | 3.78 |
| 2021-12 | 2 | 5.41 |
| 2022-01 | 1 | 4.97 |
| 2022-02 | 5 | 3.74 |
| 2022-03 | 4 | 4.39 |
| 2022-04 | 1 | 4.17 |
| 2022-05 | 3 | 4.13 |
| 2022-06 | 4 | 4.35 |
| 2022-07 | 0 | 4.38 |
| 2022-08 | 2 | 4.33 |
| 2022-09 | 7 | 4.16 |
| 2022-10 | 0 | 4.1 |
| 2022-11 | 1 | 4.7 |
| 2022-12 | 0 | 4.67 |
| 2023-01 | 6 | 5.09 |
| 2023-02 | 0 | 4.36 |
| 2023-03 | 20 | 5.24 |
| 2023-04 | 13 | 4.82 |
| 2023-05 | 2 | 4.84 |
| 2023-06 | 4 | 4.5 |
| 2023-07 | 4 | 4.29 |
| 2023-08 | 4 | 5.05 |
| 2023-09 | 3 | 4.83 |
| 2023-10 | 6 | 4.41 |
| 2023-11 | 4 | 7.93 |
| 2023-12 | 1 | 8.8 |
| 2024-01 | 0 | 6.2 |
| 2024-02 | 6 | 6.57 |
| 2024-03 | 21 | 5.26 |
| 2024-04 | 5 | 5.97 |
| 2024-05 | 2 | 8.82 |
| 2024-06 | 2 | 8.82 |
| 2024-07 | 0 | 4.91 |
| 2024-08 | 1 | 4.86 |
| 2024-09 | 1 | 4.76 |
| 2024-10 | 3 | 6.15 |
| 2024-11 | 1 | 5.22 |
| 2024-12 | 2 | 7.58 |
| 2025-01 | 0 | 8.91 |
| 2025-02 | 1 | 6.11 |
| 2025-03 | 2 | 5.08 |
| 2025-04 | 2 | 5.43 |
| 2025-05 | 6 | 5.98 |
| 2025-06 | 3 | 5.09 |
| 2025-07 | 6 | 5.28 |
| 2025-08 | 3 | 4.37 |
| 2025-09 | 2 | 4.58 |
| 2025-10 | 6 | 5.09 |
| 2025-11 | 3 | 5.68 |
| 2025-12 | 0 | 5.94 |
| 2026-01 | 2 | 5.53 |
| 2026-02 | 3 | 5.56 |
| 2026-03 | 3 | 5.59 |
| 2026-04 | 4 | 7 |
| 2026-05 | 3 | 4.7 |
| 2026-06 | 1 | 4.85 |
Failure-mode summaryAI-generated
40 linked report narratives available — no AI summary generated yet.
Recall history
| Initiated | Recall # | Class | Status | Reason | Quantity | Link basis |
|---|---|---|---|---|---|---|
| 2013-08-29 | Z-0191-2014 | Class II | Terminated | Pillow valve included in the FMS Duo outflow tubing set and the FMS Solo intermediary tubing set may not perform as intended. may result in backflow of irrigation fluid into the One Day Set which may potentially lead to patient cross-contaminationDistribution: Worldwide Distribution - USA (Nationwide) and in the countries of: Australia , Austria , Belgium , Canada , Czech Republic , Denmark , Finland , France, Germany , India, Ireland , Israel, Italy , Latvia , Netherlands , Norway , Nepal, Poland , Portugal , Spain , Sweden , Switzerland , United Kingdom. | 368 pk | clearance family |
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2026-06-25 | 1221934-2026-02786 | Malfunction | Available | exact di |
| 2026-05-28 | 1221934-2026-02292 | Malfunction | Available | exact di |
| 2026-05-27 | 1221934-2026-02244 | Malfunction | Available | exact di |
| 2026-05-08 | 1221934-2026-01962 | Malfunction | Available | exact di |
| 2026-04-30 | 1221934-2026-01811 | Malfunction | Available | exact di |
| 2026-04-27 | 1221934-2026-01699 | Malfunction | Available | exact di |
| 2026-04-16 | 1221934-2026-01510 | Malfunction | Available | exact di |
| 2026-04-02 | 1221934-2026-01367 | Malfunction | Available | exact di |
| 2026-03-25 | 1221934-2026-01230 | Malfunction | Available | exact di |
| 2026-03-25 | 1221934-2026-01231 | Malfunction | Available | exact di |
| 2026-03-20 | 1221934-2026-01177 | Malfunction | Available | exact di |
| 2026-02-25 | 1221934-2026-00884 | Malfunction | Available | exact di |
| 2026-02-04 | 1221934-2026-00517 | Malfunction | Available | exact di |
| 2026-02-04 | 1221934-2026-00504 | Malfunction | Available | exact di |
| 2026-01-12 | 1221934-2026-00185 | Malfunction | Available | exact di |
Showing the most recent 200 of 303 linked reports.
Showing 1–15 of 200
Regulatory clearances
Predicate lineage
K951843
Cited as predicate by: K132883
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
None in the loaded window.
Similar devices
- 0 Deg 4mm AC Arthroscope Poc
- 1.2mm InnerVue II Scope Kit BIOVISION TECHNOLOGIES, LLC
- 1.9mm Arthroscope, 30°, Autoclavable Nexus Cmf, L.L.C.
- 10K Conmed Corporation
- 10K Conmed Corporation
- 10K Conmed Corporation
- 10K Conmed Corporation
- 10K/24K Conmed Corporation
- 10K/24K Conmed Corporation
- 10K/24K Conmed Corporation
- 10K/24K Conmed Corporation
- 24K Conmed Corporation
Select up to two to place side-by-side with this device.