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.
251 linked reportsInjury 124Malfunction 122Death 4Other 1
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 0 | 4 |
| 2019-02 | 0 | 2.58 |
| 2019-03 | 0 | 3.29 |
| 2019-04 | 5 | 4 |
| 2019-05 | 2 | 2.2 |
| 2019-06 | 5 | 5 |
| 2019-07 | 0 | 4.59 |
| 2019-08 | 0 | 3.42 |
| 2019-09 | 2 | 2.33 |
| 2019-10 | 4 | 3.5 |
| 2019-11 | 0 | 2.93 |
| 2019-12 | 3 | 4.27 |
| 2020-01 | 0 | 3.67 |
| 2020-02 | 2 | 4 |
| 2020-03 | 0 | 3.88 |
| 2020-04 | 5 | 3.27 |
| 2020-05 | 2 | 2.71 |
| 2020-06 | 0 | 5 |
| 2020-07 | 0 | 2.05 |
| 2020-08 | 0 | 2.67 |
| 2020-09 | 2 | 2.62 |
| 2020-10 | 0 | 4 |
| 2020-11 | 0 | 3.31 |
| 2020-12 | 8 | 4.33 |
| 2021-01 | 2 | 2.25 |
| 2021-02 | 0 | 4.14 |
| 2021-03 | 3 | 3.44 |
| 2021-04 | 5 | 3.8 |
| 2021-05 | 0 | 2.69 |
| 2021-06 | 0 | 6.18 |
| 2021-07 | 0 | 8 |
| 2021-08 | 5 | 4.26 |
| 2021-09 | 8 | 4.29 |
| 2021-10 | 2 | 5.75 |
| 2021-11 | 3 | 4.21 |
| 2021-12 | 8 | 5.58 |
| 2022-01 | 2 | 4.76 |
| 2022-02 | 0 | 3.06 |
| 2022-03 | 0 | 6.19 |
| 2022-04 | 2 | 4.15 |
| 2022-05 | 2 | 5 |
| 2022-06 | 2 | 2.13 |
| 2022-07 | 2 | 3.87 |
| 2022-08 | 0 | 3.42 |
| 2022-09 | 2 | 3.15 |
| 2022-10 | 1 | 3 |
| 2022-11 | 0 | 3.89 |
| 2022-12 | 2 | 11.2 |
| 2023-01 | 5 | 20.62 |
| 2023-02 | 2 | 9.35 |
| 2023-03 | 0 | 12.22 |
| 2023-04 | 3 | 13.21 |
| 2023-05 | 0 | 18.4 |
| 2023-06 | 0 | 18.95 |
| 2023-07 | 0 | 11.93 |
| 2023-08 | 6 | 11.5 |
| 2023-09 | 0 | 10.06 |
| 2023-10 | 14 | 10.82 |
| 2023-11 | 0 | 9.45 |
| 2023-12 | 3 | 11.69 |
| 2024-01 | 2 | 9.13 |
| 2024-02 | 13 | 11.61 |
| 2024-03 | 4 | 12.31 |
| 2024-04 | 3 | 10.69 |
| 2024-05 | 3 | 12.26 |
| 2024-06 | 7 | 9.57 |
| 2024-07 | 2 | 10.33 |
| 2024-08 | 0 | 11.61 |
| 2024-09 | 2 | 13.31 |
| 2024-10 | 4 | 10.49 |
| 2024-11 | 16 | 8.09 |
| 2024-12 | 3 | 12.53 |
| 2025-01 | 0 | 11.32 |
| 2025-02 | 0 | 12.94 |
| 2025-03 | 6 | 9.6 |
| 2025-04 | 5 | 10.36 |
| 2025-05 | 0 | 9.76 |
| 2025-06 | 6 | 9.05 |
| 2025-07 | 0 | 9.3 |
| 2025-08 | 3 | 9.82 |
| 2025-09 | 7 | 9.47 |
| 2025-10 | 3 | 8.89 |
| 2025-11 | 9 | 9.82 |
| 2025-12 | 0 | 9.93 |
| 2026-01 | 3 | 12.47 |
| 2026-02 | 3 | 17.64 |
| 2026-03 | 0 | 8.42 |
| 2026-04 | 6 | 8.76 |
| 2026-05 | 3 | 6.15 |
| 2026-06 | 14 | 8.38 |
Failure-mode summaryAI-generated
40 linked report narratives available — no AI summary generated yet.
Recall history
No recalls linked.
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2026-06-25 | 1222780-2026-00405 | Injury | Available | catalog number |
| 2026-06-17 | 1222780-2026-00387 | Malfunction | Available | catalog number |
| 2026-06-09 | 1222780-2026-00373 | Malfunction | Available | catalog number |
| 2026-06-09 | 1222780-2026-00372 | Malfunction | Available | catalog number |
| 2026-06-08 | 25427002 | Malfunction | Available | catalog number |
| 2026-05-05 | 1222780-2026-00198 | Injury | Available | catalog number |
| 2026-04-21 | 1222780-2026-00172 | Malfunction | Available | catalog number |
| 2026-04-03 | 1222780-2026-00155 | Injury | Available | catalog number |
| 2026-02-10 | 1222780-2026-00051 | Malfunction | Available | catalog number |
| 2026-01-05 | 1222780-2026-00001 | Injury | Available | catalog number |
| 2025-11-19 | 23593599 | Malfunction | Available | catalog number |
| 2025-11-17 | 1222780-2025-00577 | Injury | Available | catalog number |
| 2025-11-13 | 1222780-2025-00573 | Malfunction | Available | catalog number |
| 2025-11-07 | 1222780-2025-00564 | Injury | Available | catalog number |
| 2025-10-31 | 1222780-2025-00556 | Malfunction | Available | catalog number |
Showing the most recent 104 of 251 linked reports.
Showing 1–15 of 104
Regulatory clearances
- 510(k)K142029Substantially equivalent (SESE) · 2014-11-26clearance 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 |
|---|---|---|---|---|
| 2025-11-04 | OAI | Official action indicated | Hologic, Inc | 3 |
| 2025-11-04 | OAI | Official action indicated | Hologic, Inc | 3 |
| 2024-12-18 | WL | Warning Letter | Hologic, Inc | — |
| 2024-12-18 | WL | Warning Letter | Hologic, Inc | — |
| 2024-09-24 | OAI | Official action indicated | Hologic, Inc | 5 |
| 2024-09-24 | OAI | Official action indicated | Hologic, Inc | 5 |
| 2024-09-12 | VAI | Voluntary action indicated | Hologic Surgical Products Costa Rica, S.R.L. | 0 |
| 2024-08-13 | NAI | No action indicated | Hologic, Inc. | 0 |
| 2024-08-13 | NAI | No action indicated | Hologic, Inc. | 0 |
| 2022-12-14 | NAI | No action indicated | Bolder Surgical, LLC | 0 |
| 2022-10-14 | OAI | Official action indicated | Hologic, Inc. | 4 |
| 2022-10-14 | OAI | Official action indicated | Hologic, Inc. | 4 |
| 2022-08-03 | VAI | Voluntary action indicated | Health Beacons, Inc. | 1 |
| 2020-02-25 | NAI | No action indicated | Health Beacons, Inc. | 0 |
| 2018-12-10 | NAI | No action indicated | Hologic, Inc. | 0 |
| 2018-12-10 | NAI | No action indicated | Hologic, Inc. | 0 |
| 2018-02-27 | NAI | No action indicated | Gynesonics, Inc. | 0 |
| 2017-11-30 | NAI | No action indicated | Hologic, Inc | 0 |
| 2017-11-30 | NAI | No action indicated | Hologic, Inc | 0 |
| 2017-11-27 | VAI | Voluntary action indicated | Bolder Surgical, LLC | 6 |
| 2017-10-25 | NAI | No action indicated | Hologic, Inc. | 0 |
| 2017-10-25 | NAI | No action indicated | Hologic, Inc. | 0 |
Similar devices
- SELF SEALING SEAL 1 SIZE FITS ALL FOR KARL STORZ URO OBP CORPORATION
- AED NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
- AED NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
- AED NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
- AED NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
- AED NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
- AED NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
- AED NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
- AED NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
- AED NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
- AED NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
- AED NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
Select up to two to place side-by-side with this device.