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.
60 linked reportsInjury 55Malfunction 5
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 0 | 9.07 |
| 2019-02 | 0 | 8.57 |
| 2019-03 | 0 | 12.63 |
| 2019-04 | 0 | 7.71 |
| 2019-05 | 0 | 11.6 |
| 2019-06 | 0 | 8.54 |
| 2019-07 | 0 | 8.04 |
| 2019-08 | 0 | 8.24 |
| 2019-09 | 0 | 8.9 |
| 2019-10 | 0 | 10.13 |
| 2019-11 | 0 | 9.05 |
| 2019-12 | 0 | 9.33 |
| 2020-01 | 0 | 12.14 |
| 2020-02 | 0 | 9.81 |
| 2020-03 | 0 | 14.35 |
| 2020-04 | 0 | 10.59 |
| 2020-05 | 0 | 5.25 |
| 2020-06 | 0 | 11.38 |
| 2020-07 | 0 | 9.04 |
| 2020-08 | 0 | 7.8 |
| 2020-09 | 0 | 10.18 |
| 2020-10 | 0 | 11.14 |
| 2020-11 | 0 | 14.81 |
| 2020-12 | 0 | 8.96 |
| 2021-01 | 0 | 9.95 |
| 2021-02 | 2 | 9.31 |
| 2021-03 | 30 | 10.66 |
| 2021-04 | 9 | 9.61 |
| 2021-05 | 12 | 6.71 |
| 2021-06 | 3 | 11.05 |
| 2021-07 | 2 | 7.93 |
| 2021-08 | 0 | 12.27 |
| 2021-09 | 2 | 8.94 |
| 2021-10 | 0 | 7.52 |
| 2021-11 | 0 | 7.83 |
| 2021-12 | 0 | 10.76 |
| 2022-01 | 0 | 9 |
| 2022-02 | 0 | 6.09 |
| 2022-03 | 0 | 7.55 |
| 2022-04 | 0 | 9.96 |
| 2022-05 | 0 | 7.58 |
| 2022-06 | 0 | 11.93 |
| 2022-07 | 0 | 8.33 |
| 2022-08 | 0 | 8.97 |
| 2022-09 | 0 | 10.41 |
| 2022-10 | 0 | 10.07 |
| 2022-11 | 0 | 9.12 |
| 2022-12 | 0 | 16.6 |
| 2023-01 | 0 | 10.33 |
| 2023-02 | 0 | 7.77 |
| 2023-03 | 0 | 9.2 |
| 2023-04 | 0 | 12.38 |
| 2023-05 | 0 | 8.15 |
| 2023-06 | 0 | 16.63 |
| 2023-07 | 0 | 11.26 |
| 2023-08 | 0 | 7.85 |
| 2023-09 | 0 | 14.69 |
| 2023-10 | 0 | 27.15 |
| 2023-11 | 0 | 25.5 |
| 2023-12 | 0 | 19.38 |
| 2024-01 | 0 | 19.8 |
| 2024-02 | 0 | 27.42 |
| 2024-03 | 0 | 18.08 |
| 2024-04 | 0 | 34.25 |
| 2024-05 | 0 | 13.94 |
| 2024-06 | 0 | 14.67 |
| 2024-07 | 0 | 8.54 |
| 2024-08 | 0 | 10.39 |
| 2024-09 | 0 | 18.93 |
| 2024-10 | 0 | 16.78 |
| 2024-11 | 0 | 17.14 |
| 2024-12 | 0 | 15.78 |
| 2025-01 | 0 | 17.15 |
| 2025-02 | 0 | 10.29 |
| 2025-03 | 0 | 20.08 |
| 2025-04 | 0 | 20.58 |
| 2025-05 | 0 | 18.5 |
| 2025-06 | 0 | 15.82 |
| 2025-07 | 0 | 16.69 |
| 2025-08 | 0 | 13.43 |
| 2025-09 | 0 | 15.56 |
| 2025-10 | 0 | 17.6 |
| 2025-11 | 0 | 15.55 |
| 2025-12 | 0 | 25.94 |
| 2026-01 | 0 | 21.23 |
| 2026-02 | 0 | 19.12 |
| 2026-03 | 0 | 17.8 |
| 2026-04 | 0 | 25.19 |
| 2026-05 | 0 | 15.94 |
| 2026-06 | 0 | 20.25 |
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 |
|---|---|---|---|---|
| 2021-09-03 | 9610612-2021-00618 | Injury | Available | catalog number |
| 2021-07-06 | 9610612-2021-00514 | Injury | Available | catalog number |
| 2021-06-15 | 9610612-2021-00438 | Injury | Available | catalog number |
| 2021-05-14 | 9610612-2021-00365 | Injury | Available | catalog number |
| 2021-05-05 | 9610612-2021-00362 | Injury | Available | catalog number |
| 2021-05-04 | 9610612-2021-00359 | Injury | Available | catalog number |
| 2021-05-04 | 9610612-2021-00354 | Injury | Available | catalog number |
| 2021-04-12 | 9610612-2021-00294 | Injury | Available | catalog number |
| 2021-04-12 | 9610612-2021-00287 | Injury | Available | catalog number |
| 2021-04-07 | 9610612-2021-00291 | Injury | Available | catalog number |
| 2021-04-01 | 9610612-2021-00293 | Malfunction | Available | catalog number |
| 2021-03-29 | 9610612-2021-00242 | Injury | Available | catalog number |
| 2021-03-26 | 9610612-2021-00314 | Injury | Available | catalog number |
| 2021-03-23 | 9610612-2021-00214 | Injury | Available | catalog number |
| 2021-03-19 | 9610612-2021-00233 | Malfunction | Available | catalog number |
Showing the most recent 22 of 60 linked reports.
Showing 1–15 of 22
Regulatory clearances
None linked.
Manufacturer compliance record
| Date | Type | Outcome | Facility | Citations |
|---|---|---|---|---|
| 2025-07-11 | NAI | No action indicated | Aesculap Inc | 0 |
| 2025-07-11 | NAI | No action indicated | Aesculap Inc | 0 |
| 2022-07-21 | NAI | No action indicated | Aesculap AG | 0 |
| 2022-07-21 | NAI | No action indicated | Aesculap AG | 0 |
| 2021-08-11 | VAI | Voluntary action indicated | Aesculap Inc | 3 |
| 2021-08-11 | VAI | Voluntary action indicated | Aesculap Inc | 3 |
| 2018-06-13 | VAI | Voluntary action indicated | Aesculap Inc | 0 |
| 2018-06-13 | VAI | Voluntary action indicated | Aesculap Inc | 0 |
| 2016-09-22 | NAI | No action indicated | Aesculap AG | 0 |
| 2016-09-22 | NAI | No action indicated | Aesculap AG | 0 |
| 2016-09-14 | VAI | Voluntary action indicated | Aesculap Inc | 0 |
| 2016-09-14 | VAI | Voluntary action indicated | Aesculap Inc | 0 |
| 2016-07-13 | NAI | No action indicated | Aesculap Inc | 0 |
| 2016-07-13 | NAI | No action indicated | Aesculap Inc | 0 |
| 2015-07-16 | NAI | No action indicated | Aesculap AG | 1 |
| 2015-07-16 | NAI | No action indicated | Aesculap AG | 1 |
| 2015-05-05 | NAI | No action indicated | Aesculap Inc | 0 |
| 2015-05-05 | NAI | No action indicated | Aesculap Inc | 0 |
| 2014-10-23 | NAI | No action indicated | Aesculap Inc | 0 |
| 2014-10-23 | NAI | No action indicated | Aesculap Inc | 0 |
| 2011-09-26 | WL | Warning Letter | Aesculap AG | — |
| 2011-09-26 | WL | Warning Letter | Aesculap AG | — |
Similar devices
- DR. BRANCEL CHOLE KIT APPLIED MEDICAL RESOURCES CORPORATION
- LAP CHOLE KIT APPLIED MEDICAL RESOURCES CORPORATION
- LAP CHOLE KIT APPLIED MEDICAL RESOURCES CORPORATION
- MENACHERY KIT APPLIED MEDICAL RESOURCES CORPORATION
- PARTNERS LC KIT 006 APPLIED MEDICAL RESOURCES CORPORATION
- 10mm CLIP APPLIER CHOLE KIT APPLIED MEDICAL RESOURCES CORPORATION
- 10mm CLIP APPLIER LAP-CHOLE KIT APPLIED MEDICAL RESOURCES CORPORATION
- 10mm CLIP LAP CHOLE APPLIED MEDICAL RESOURCES CORPORATION
- 10mm CLIP/BLADED TROCARS APPLIED MEDICAL RESOURCES CORPORATION
- 10mm CLIP/NON BLADED TROCARS APPLIED MEDICAL RESOURCES CORPORATION
- 5MM Fios® SURGICAL KIT APPLIED MEDICAL RESOURCES CORPORATION
- 5MM UNIVERSAL LAP CHOLE PACK APPLIED MEDICAL RESOURCES CORPORATION
Select up to two to place side-by-side with this device.