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.
16 linked reportsMalfunction 15Death 1
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 0 | 2.42 |
| 2019-02 | 0 | 3.53 |
| 2019-03 | 0 | 2.95 |
| 2019-04 | 0 | 3.13 |
| 2019-05 | 0 | 2.46 |
| 2019-06 | 2 | 3.58 |
| 2019-07 | 0 | 2.42 |
| 2019-08 | 0 | 2.47 |
| 2019-09 | 0 | 2.47 |
| 2019-10 | 0 | 2.71 |
| 2019-11 | 0 | 2.12 |
| 2019-12 | 0 | 2.35 |
| 2020-01 | 0 | 2.55 |
| 2020-02 | 0 | 2.7 |
| 2020-03 | 0 | 2.28 |
| 2020-04 | 0 | 2.54 |
| 2020-05 | 0 | 1.98 |
| 2020-06 | 0 | 2.78 |
| 2020-07 | 1 | 2.77 |
| 2020-08 | 0 | 4.33 |
| 2020-09 | 1 | 4.4 |
| 2020-10 | 0 | 3.99 |
| 2020-11 | 0 | 4.47 |
| 2020-12 | 3 | 3.87 |
| 2021-01 | 0 | 3.99 |
| 2021-02 | 0 | 3.89 |
| 2021-03 | 0 | 4.83 |
| 2021-04 | 0 | 4.7 |
| 2021-05 | 0 | 4.05 |
| 2021-06 | 0 | 4.28 |
| 2021-07 | 0 | 3.88 |
| 2021-08 | 0 | 3.87 |
| 2021-09 | 0 | 3.91 |
| 2021-10 | 0 | 3.99 |
| 2021-11 | 0 | 3.49 |
| 2021-12 | 0 | 4.46 |
| 2022-01 | 0 | 4.57 |
| 2022-02 | 0 | 5.03 |
| 2022-03 | 0 | 5.45 |
| 2022-04 | 0 | 6.48 |
| 2022-05 | 0 | 5.46 |
| 2022-06 | 0 | 6.07 |
| 2022-07 | 0 | 6.34 |
| 2022-08 | 3 | 6.38 |
| 2022-09 | 0 | 5.53 |
| 2022-10 | 0 | 5.35 |
| 2022-11 | 0 | 5.52 |
| 2022-12 | 0 | 6 |
| 2023-01 | 0 | 5.73 |
| 2023-02 | 0 | 4.87 |
| 2023-03 | 0 | 5.86 |
| 2023-04 | 0 | 5.47 |
| 2023-05 | 0 | 5.86 |
| 2023-06 | 0 | 7.1 |
| 2023-07 | 0 | 6.1 |
| 2023-08 | 0 | 6.28 |
| 2023-09 | 0 | 5.92 |
| 2023-10 | 0 | 6.38 |
| 2023-11 | 0 | 5.76 |
| 2023-12 | 2 | 6.05 |
| 2024-01 | 0 | 5.53 |
| 2024-02 | 0 | 6.18 |
| 2024-03 | 0 | 5.56 |
| 2024-04 | 0 | 6.32 |
| 2024-05 | 2 | 5.3 |
| 2024-06 | 0 | 7.07 |
| 2024-07 | 0 | 5.75 |
| 2024-08 | 0 | 6.5 |
| 2024-09 | 0 | 6.28 |
| 2024-10 | 0 | 7.11 |
| 2024-11 | 0 | 4.55 |
| 2024-12 | 1 | 4.77 |
| 2025-01 | 0 | 4.42 |
| 2025-02 | 0 | 4.03 |
| 2025-03 | 0 | 5.17 |
| 2025-04 | 0 | 4.67 |
| 2025-05 | 0 | 4.69 |
| 2025-06 | 0 | 4.58 |
| 2025-07 | 0 | 4.68 |
| 2025-08 | 1 | 5.45 |
| 2025-09 | 0 | 3.97 |
| 2025-10 | 0 | 4.59 |
| 2025-11 | 0 | 4.86 |
| 2025-12 | 0 | 6.15 |
| 2026-01 | 0 | 4.95 |
| 2026-02 | 0 | 5.05 |
| 2026-03 | 0 | 5.77 |
| 2026-04 | 0 | 6.2 |
| 2026-05 | 0 | 5.86 |
| 2026-06 | 0 | 5.01 |
Failure-mode summaryAI-generated
16 linked report narratives available — no AI summary generated yet.
Recall history
| Initiated | Recall # | Class | Status | Reason | Quantity | Link basis |
|---|---|---|---|---|---|---|
| 2021-02-26 | Z-1428-2021 | Class II | Terminated | Their is a potential that Video Processor/Illuminators may exhibit flickering, loss of image or unintended reboots.Distribution: Worldwide distribution - US Nationwide distribution including in the states of CA, CO, FL, IL, MA MI, MS NC, NV, OK, PA, SC, TN, TX, VA, WA, WI and the countries of AE, CA, CN, CZ, DE, ES, HK, JP, KR, KW, MX, MY, PH, RO, SG, TR, TW. | 125 units | clearance family |
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2025-08-21 | 3012345110-2025-00004 | Malfunction | Available | exact di |
| 2024-12-19 | 3012345110-2024-00003 | Malfunction | Available | exact di |
| 2024-05-17 | 3012345110-2024-00002 | Malfunction | Available | catalog number |
| 2023-12-06 | 0002936485-2023-01223 | Malfunction | Available | catalog number |
| 2022-08-29 | 3012345110-2022-00007 | Malfunction | Available | catalog number |
| 2020-12-07 | 3012345110-2020-00009 | Malfunction | Available | catalog number |
| 2020-09-14 | 3012345110-2020-00005 | Death | Available | exact di |
| 2020-07-22 | 3012345110-2020-00003 | Malfunction | Available | exact di |
| 2019-06-19 | 3012345110-2019-00007 | Malfunction | Available | catalog number |
Showing the most recent 9 of 16 linked reports.
Regulatory clearances
- 510(k)K150956Substantially equivalent (SESE) · 2016-05-23clearance family
Predicate lineage
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 |
|---|---|---|---|---|
| 2011-06-30 | VAI | Voluntary action indicated | Novadaq Technologies, Inc. | 8 |
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