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.
32 linked reportsMalfunction 26Injury 6
| 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 | 0 | 4 |
| 2019-05 | 0 | 2.2 |
| 2019-06 | 0 | 5 |
| 2019-07 | 0 | 4.59 |
| 2019-08 | 0 | 3.42 |
| 2019-09 | 0 | 2.33 |
| 2019-10 | 0 | 3.5 |
| 2019-11 | 0 | 2.93 |
| 2019-12 | 0 | 4.27 |
| 2020-01 | 0 | 3.67 |
| 2020-02 | 0 | 4 |
| 2020-03 | 0 | 3.88 |
| 2020-04 | 0 | 3.27 |
| 2020-05 | 0 | 2.71 |
| 2020-06 | 0 | 5 |
| 2020-07 | 1 | 2.05 |
| 2020-08 | 0 | 2.67 |
| 2020-09 | 0 | 2.62 |
| 2020-10 | 0 | 4 |
| 2020-11 | 0 | 3.31 |
| 2020-12 | 0 | 4.33 |
| 2021-01 | 0 | 2.25 |
| 2021-02 | 0 | 4.14 |
| 2021-03 | 0 | 3.44 |
| 2021-04 | 0 | 3.8 |
| 2021-05 | 0 | 2.69 |
| 2021-06 | 0 | 6.18 |
| 2021-07 | 0 | 8 |
| 2021-08 | 0 | 4.26 |
| 2021-09 | 0 | 4.29 |
| 2021-10 | 0 | 5.75 |
| 2021-11 | 0 | 4.21 |
| 2021-12 | 0 | 5.58 |
| 2022-01 | 0 | 4.76 |
| 2022-02 | 3 | 3.06 |
| 2022-03 | 0 | 6.19 |
| 2022-04 | 0 | 4.15 |
| 2022-05 | 0 | 5 |
| 2022-06 | 0 | 2.13 |
| 2022-07 | 0 | 3.87 |
| 2022-08 | 0 | 3.42 |
| 2022-09 | 0 | 3.15 |
| 2022-10 | 1 | 3 |
| 2022-11 | 0 | 3.89 |
| 2022-12 | 0 | 11.2 |
| 2023-01 | 0 | 20.62 |
| 2023-02 | 0 | 9.35 |
| 2023-03 | 0 | 12.22 |
| 2023-04 | 0 | 13.21 |
| 2023-05 | 0 | 18.4 |
| 2023-06 | 0 | 18.95 |
| 2023-07 | 0 | 11.93 |
| 2023-08 | 0 | 11.5 |
| 2023-09 | 0 | 10.06 |
| 2023-10 | 0 | 10.82 |
| 2023-11 | 0 | 9.45 |
| 2023-12 | 0 | 11.69 |
| 2024-01 | 0 | 9.13 |
| 2024-02 | 0 | 11.61 |
| 2024-03 | 0 | 12.31 |
| 2024-04 | 1 | 10.69 |
| 2024-05 | 0 | 12.26 |
| 2024-06 | 0 | 9.57 |
| 2024-07 | 1 | 10.33 |
| 2024-08 | 0 | 11.61 |
| 2024-09 | 17 | 13.31 |
| 2024-10 | 0 | 10.49 |
| 2024-11 | 1 | 8.09 |
| 2024-12 | 0 | 12.53 |
| 2025-01 | 0 | 11.32 |
| 2025-02 | 0 | 12.94 |
| 2025-03 | 2 | 9.6 |
| 2025-04 | 2 | 10.36 |
| 2025-05 | 0 | 9.76 |
| 2025-06 | 0 | 9.05 |
| 2025-07 | 0 | 9.3 |
| 2025-08 | 1 | 9.82 |
| 2025-09 | 0 | 9.47 |
| 2025-10 | 1 | 8.89 |
| 2025-11 | 0 | 9.82 |
| 2025-12 | 0 | 9.93 |
| 2026-01 | 0 | 12.47 |
| 2026-02 | 0 | 17.64 |
| 2026-03 | 0 | 8.42 |
| 2026-04 | 0 | 8.76 |
| 2026-05 | 1 | 6.15 |
| 2026-06 | 0 | 8.38 |
Failure-mode summaryAI-generated
32 linked report narratives available — no AI summary generated yet.
Recall history
| Initiated | Recall # | Class | Status | Reason | Quantity | Link basis |
|---|---|---|---|---|---|---|
| 2022-06-07 | Z-1467-2022 | Class II | Open, Classified | Electrical component failure within the control unit. The observed failure mode is a loss of function of the device when used with handpiece and foot switch.Distribution: AZ CA CO IL KS MA MI MN MO NY OK PA TN TX TX WA Foreign: United Kingdom Ireland Netherlands Reunion Spain | 33 units | code info di |
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2026-05-04 | 1282497-2026-00024 | Injury | Available | exact di |
| 2025-10-21 | 1282497-2025-00616 | Malfunction | Available | exact di |
| 2025-08-05 | 1282497-2025-00531 | Malfunction | Available | exact di |
| 2025-04-14 | 21832473 | Malfunction | Available | model number |
| 2025-04-03 | 21760828 | Malfunction | Available | model number |
| 2025-03-24 | 1282497-2025-00187 | Malfunction | Available | exact di |
| 2025-03-03 | 1282497-2025-00110 | Malfunction | Available | exact di |
| 2024-11-19 | 20722691 | Malfunction | Available | exact di |
| 2024-09-05 | 1282497-2024-00362 | Malfunction | Available | exact di |
| 2024-09-05 | 1282497-2024-00357 | Malfunction | Available | exact di |
| 2024-09-05 | 1282497-2024-00363 | Malfunction | Available | exact di |
| 2024-09-05 | 1282497-2024-00369 | Malfunction | Available | exact di |
| 2024-09-05 | 1282497-2024-00375 | Malfunction | Available | exact di |
| 2024-09-05 | 1282497-2024-00365 | Malfunction | Available | exact di |
| 2024-09-05 | 1282497-2024-00367 | Malfunction | Available | exact di |
Showing 1–15 of 32
Regulatory clearances
- 510(k)K132015Substantially equivalent (SESE) · 2013-12-13clearance 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 |
|---|---|---|---|---|
| 2025-07-16 | NAI | No action indicated | Covidien LLC | 0 |
| 2025-07-16 | NAI | No action indicated | Covidien LLC | 0 |
| 2024-11-21 | NAI | No action indicated | Covidien, LP | 0 |
| 2024-11-21 | NAI | No action indicated | Covidien, LP | 0 |
| 2022-11-18 | VAI | Voluntary action indicated | Covidien LP | 1 |
| 2022-11-18 | VAI | Voluntary action indicated | Covidien LP | 1 |
| 2022-09-08 | VAI | Voluntary action indicated | Covidien | 0 |
| 2022-09-08 | VAI | Voluntary action indicated | Covidien | 0 |
| 2022-04-28 | OAI | Official action indicated | Covidien | 2 |
| 2022-04-28 | OAI | Official action indicated | Covidien | 2 |
| 2020-02-28 | VAI | Voluntary action indicated | Covidien, LP | 1 |
| 2020-02-28 | VAI | Voluntary action indicated | Covidien, LP | 1 |
| 2018-09-19 | NAI | No action indicated | Covidien | 0 |
| 2018-09-19 | NAI | No action indicated | Covidien | 0 |
| 2017-09-22 | VAI | Voluntary action indicated | Covidien, LLC | 2 |
| 2017-09-22 | VAI | Voluntary action indicated | Covidien, LLC | 2 |
| 2017-08-09 | NAI | No action indicated | Covidien | 0 |
| 2017-08-09 | NAI | No action indicated | Covidien | 0 |
| 2016-10-31 | NAI | No action indicated | Covidien | 0 |
| 2016-10-31 | NAI | No action indicated | Covidien | 0 |
| 2012-06-14 | WL | Warning Letter | Covidien, LP | — |
| 2012-06-14 | WL | Warning Letter | Covidien, LP | — |
| 2011-10-04 | WL | Warning Letter | Oridion Medical 1987 Ltd. | — |
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