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.
19 linked reportsMalfunction 19
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-12 | 1 | 1 |
| 2020-01 | 2 | 1.67 |
| 2020-03 | 2 | 2 |
| 2020-05 | 0 | 4 |
| 2020-06 | 1 | 7 |
| 2020-07 | 0 | 11 |
| 2020-08 | 3 | 3.67 |
| 2020-09 | 2 | 5 |
| 2020-10 | 0 | 3.5 |
| 2020-11 | 4 | 7 |
| 2020-12 | 1 | 5 |
| 2021-01 | 0 | 6 |
| 2021-03 | 0 | 4 |
| 2021-04 | 0 | 9 |
| 2021-05 | 0 | 4 |
| 2021-06 | 1 | 5.5 |
| 2021-07 | 0 | 2 |
| 2021-08 | 2 | 1.5 |
| 2021-09 | 0 | 3 |
| 2021-10 | 0 | 6 |
| 2021-11 | 0 | 6 |
| 2021-12 | 0 | 2 |
| 2022-01 | 0 | 4 |
| 2022-02 | 0 | 6 |
| 2022-03 | 0 | 4.33 |
| 2022-04 | 0 | 8 |
| 2022-05 | 0 | 12 |
| 2022-06 | 0 | 4.5 |
| 2022-07 | 0 | 6 |
| 2022-09 | 0 | 3.5 |
| 2022-10 | 0 | 5 |
| 2022-11 | 0 | 3.67 |
| 2022-12 | 0 | 4 |
| 2023-01 | 0 | 2 |
| 2023-02 | 0 | 2 |
| 2023-03 | 0 | 5.5 |
| 2023-04 | 0 | 1 |
| 2023-05 | 0 | 1 |
| 2023-06 | 0 | 2 |
| 2023-07 | 0 | 2.75 |
| 2023-08 | 0 | 1 |
| 2023-09 | 0 | 5 |
| 2023-10 | 0 | 1.67 |
| 2023-12 | 0 | 6 |
| 2024-01 | 0 | 2 |
| 2024-02 | 0 | 1.5 |
| 2024-03 | 0 | 1.8 |
| 2024-05 | 0 | 4 |
| 2024-06 | 0 | 5.5 |
| 2024-07 | 0 | 2.67 |
| 2024-08 | 0 | 1 |
| 2024-09 | 0 | 4 |
| 2024-10 | 0 | 2 |
| 2024-11 | 0 | 2 |
| 2024-12 | 0 | 2 |
| 2025-06 | 0 | 1.5 |
| 2025-07 | 0 | 2.33 |
| 2025-08 | 0 | 1 |
| 2025-10 | 0 | 5 |
| 2025-11 | 0 | 2 |
| 2025-12 | 0 | 3 |
| 2026-01 | 0 | 8.83 |
| 2026-02 | 0 | 13.75 |
| 2026-03 | 0 | 15.14 |
| 2026-04 | 0 | 18.83 |
| 2026-05 | 0 | 7.67 |
| 2026-06 | 0 | 62.19 |
Failure-mode summaryAI-generated
19 linked report narratives available — no AI summary generated yet.
Recall history
No recalls linked.
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2021-08-26 | 1221934-2021-02561 | Malfunction | Available | exact di |
| 2021-08-19 | 1221934-2021-02524 | Malfunction | Available | exact di |
| 2021-06-23 | 1221934-2021-01959 | Malfunction | Available | exact di |
| 2020-12-31 | 1221934-2020-04174 | Malfunction | Available | exact di |
| 2020-11-30 | 1221934-2020-03621 | Malfunction | Available | exact di |
| 2020-11-10 | 1221934-2020-03427 | Malfunction | Available | exact di |
| 2020-11-10 | 1221934-2020-03429 | Malfunction | Available | exact di |
| 2020-11-10 | 1221934-2020-03428 | Malfunction | Available | exact di |
| 2020-09-26 | 1221934-2020-02768 | Malfunction | Available | exact di |
| 2020-09-16 | 1221934-2020-02643 | Malfunction | Available | exact di |
| 2020-08-24 | 1221934-2020-02285 | Malfunction | Available | exact di |
| 2020-08-14 | 1221934-2020-02096 | Malfunction | Available | exact di |
| 2020-08-12 | 1221934-2020-02072 | Malfunction | Available | exact di |
| 2020-06-22 | 1221934-2020-01595 | Malfunction | Available | exact di |
| 2020-03-19 | 1221934-2020-00923 | Malfunction | Available | exact di |
Showing 1–15 of 19
Regulatory clearances
None linked.
Manufacturer compliance record
| Date | Type | Outcome | Facility | Citations |
|---|---|---|---|---|
| 2026-02-13 | VAI | Voluntary action indicated | NDS Surgical Imaging LLC | 1 |
| 2026-02-13 | VAI | Voluntary action indicated | NDS Surgical Imaging LLC | 1 |
| 2015-03-25 | NAI | No action indicated | NDS Surgical Imaging LLC | 1 |
| 2015-03-25 | NAI | No action indicated | NDS Surgical Imaging LLC | 1 |
| 2012-08-17 | VAI | Voluntary action indicated | NDS Surgical Imaging LLC | 4 |
| 2012-08-17 | VAI | Voluntary action indicated | NDS Surgical Imaging LLC | 4 |
| 2012-04-20 | VAI | Voluntary action indicated | NDS Surgical Imaging LLC | 1 |
| 2012-04-20 | VAI | Voluntary action indicated | NDS Surgical Imaging LLC | 1 |
| 2010-07-21 | VAI | Voluntary action indicated | NDS Surgical Imaging LLC | 1 |
| 2010-07-21 | VAI | Voluntary action indicated | NDS Surgical Imaging LLC | 1 |
Similar devices
- "C-Arm Cover Siemens ""SIREMOBIL 2000"" 3 pieces" PHARMA SEPT MEDICAL PRODUCTS (1995) LTD.
- 4K Camera Baxter Medical Systems GmbH + Co. KG
- 4K Refreshing Unit Baxter Medical Systems GmbH + Co. KG
- AED ENDOPRO-CAM® NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
- AED ENDOPRO® PRIMO SERIES CAMERA NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
- AED ENDOPRO® PRIMO SERIES CAMERA NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
- AESCULAP Aesculap AG
- AESCULAP Aesculap AG
- AESCULAP Aesculap AG
- AESCULAP Aesculap AG
- AESCULAP Aesculap AG
- AESCULAP Aesculap AG
Select up to two to place side-by-side with this device.