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.
8 linked reportsMalfunction 8
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 1 | 1 |
| 2019-02 | 1 | 1.5 |
| 2019-03 | 0 | 1.8 |
| 2019-04 | 0 | 1 |
| 2019-05 | 0 | 1 |
| 2019-06 | 1 | 1 |
| 2019-07 | 0 | 1 |
| 2019-08 | 0 | 1 |
| 2019-09 | 0 | 1 |
| 2019-10 | 0 | 1.5 |
| 2019-11 | 0 | 1 |
| 2020-05 | 0 | 1.5 |
| 2020-06 | 0 | 2.5 |
| 2020-07 | 1 | 1 |
| 2020-08 | 0 | 3 |
| 2020-09 | 1 | 1.33 |
| 2020-10 | 0 | 1.17 |
| 2020-11 | 0 | 1 |
| 2020-12 | 0 | 1.33 |
| 2021-01 | 0 | 4 |
| 2021-02 | 0 | 1 |
| 2021-05 | 0 | 1.33 |
| 2021-06 | 0 | 1 |
| 2021-10 | 1 | 1 |
| 2021-11 | 0 | 1 |
| 2021-12 | 1 | 1.33 |
| 2022-01 | 0 | 1.5 |
| 2022-02 | 0 | 1 |
| 2022-03 | 0 | 1.67 |
| 2022-04 | 0 | 1.67 |
| 2022-06 | 0 | 1 |
| 2022-07 | 0 | 2 |
| 2022-08 | 0 | 1 |
| 2022-09 | 0 | 2 |
| 2022-10 | 0 | 2 |
| 2022-11 | 0 | 1 |
| 2022-12 | 0 | 1 |
| 2023-01 | 0 | 2 |
| 2023-03 | 0 | 3 |
| 2023-06 | 0 | 2 |
| 2023-07 | 0 | 2.5 |
| 2023-08 | 0 | 2 |
| 2023-09 | 0 | 1.5 |
| 2023-10 | 0 | 2 |
| 2023-11 | 0 | 1 |
| 2023-12 | 0 | 2 |
| 2024-02 | 1 | 2 |
| 2024-03 | 0 | 1 |
| 2024-04 | 0 | 1.5 |
| 2024-07 | 0 | 2 |
| 2024-08 | 0 | 4.33 |
| 2024-09 | 0 | 6 |
| 2024-10 | 0 | 2 |
| 2024-11 | 0 | 2 |
| 2024-12 | 0 | 4 |
| 2025-01 | 0 | 3 |
| 2025-02 | 0 | 3 |
| 2025-03 | 0 | 6 |
| 2025-04 | 0 | 7 |
| 2025-06 | 0 | 2 |
| 2025-07 | 0 | 1 |
| 2025-11 | 0 | 2.5 |
| 2025-12 | 0 | 2 |
| 2026-01 | 0 | 5 |
| 2026-02 | 0 | 2 |
| 2026-03 | 0 | 3 |
| 2026-04 | 0 | 2.25 |
| 2026-05 | 0 | 2.33 |
| 2026-06 | 0 | 2 |
Failure-mode summaryAI-generated
8 linked report narratives available — no AI summary generated yet.
Recall history
| Initiated | Recall # | Class | Status | Reason | Quantity | Link basis |
|---|---|---|---|---|---|---|
| 2019-06-14 | Z-1977-2019 | Class II | Terminated | The soft, flexible cup of the Advincula Delineator may be unvalidated and could potentiall crack when subjected to excessive compressions during use, leading to serious health consequences, such as lacerations.Distribution: US distribution to state of: AZ, CA, GA, IN, LA, MA, NC, NH, NJ, NY, OH, PA, VA, and WA.. | 213 units in total | clearance family |
| 2019-06-14 | Z-1978-2019 | Class II | Terminated | The soft, flexible cup of the Advincula Delineator may be unvalidated and could potentiall crack when subjected to excessive compressions during use, leading to serious health consequences, such as lacerations.Distribution: US distribution to state of: AZ, CA, GA, IN, LA, MA, NC, NH, NJ, NY, OH, PA, VA, and WA.. | 213 units in total | clearance family |
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2024-02-01 | 18621524 | Malfunction | Available | model number |
| 2021-12-23 | 1216677-2021-00263 | Malfunction | Available | model number |
| 2021-10-04 | 12567748 | Malfunction | Available | model number |
| 2020-09-01 | 1216677-2020-00194 | Malfunction | Available | model number |
| 2020-07-22 | 10307434 | Malfunction | Available | model number |
| 2019-06-25 | 1216677-2019-00176 | Malfunction | Available | model number |
| 2019-02-06 | 1216677-2019-00016 | Malfunction | Available | model number |
| 2019-01-07 | 1216677-2018-00098 | Malfunction | Available | model number |
Regulatory clearances
- 510(k)K180429Substantially equivalent (SESE) · 2018-03-14clearance family
Manufacturer compliance record
| Date | Type | Outcome | Facility | Citations |
|---|---|---|---|---|
| 2024-02-01 | VAI | Voluntary action indicated | CooperSurgical, Inc. | 0 |
| 2023-05-16 | NAI | No action indicated | CooperSurgical, Inc. | 0 |
| 2023-05-16 | NAI | No action indicated | CooperSurgical, Inc. | 0 |
| 2023-04-27 | VAI | Voluntary action indicated | Lone Star Medical Products, Inc. | 5 |
| 2022-12-15 | NAI | No action indicated | Leisegang Feinmechanick-Optik GmbH | 0 |
| 2021-07-15 | VAI | Voluntary action indicated | CooperSurgical, Inc. | 4 |
| 2021-07-15 | VAI | Voluntary action indicated | CooperSurgical, Inc. | 4 |
| 2019-08-01 | NAI | No action indicated | CooperSurgical, Inc. | 2 |
| 2018-05-02 | NAI | No action indicated | Lone Star Medical Products, Inc. | 0 |
| 2017-12-07 | NAI | No action indicated | CooperSurgical, Inc. | 0 |
| 2017-12-07 | NAI | No action indicated | CooperSurgical, Inc. | 0 |
| 2017-05-04 | NAI | No action indicated | Lone Star Medical Products, Inc. | 0 |
| 2016-03-31 | NAI | No action indicated | CooperSurgical, Inc. | 0 |
| 2016-03-31 | NAI | No action indicated | CooperSurgical, Inc. | 0 |
| 2015-12-10 | NAI | No action indicated | Leisegang Feinmechanick-Optik GmbH | 0 |
| 2015-06-09 | WL | Warning Letter | CooperSurgical, Inc. | — |
| 2015-06-09 | WL | Warning Letter | CooperSurgical, Inc. | — |
| 2014-12-17 | OAI | Official action indicated | CooperSurgical, Inc. | 8 |
| 2014-12-17 | OAI | Official action indicated | CooperSurgical, Inc. | 8 |
| 2014-12-01 | NAI | No action indicated | CooperSurgical, Inc. | 0 |
| 2014-12-01 | NAI | No action indicated | CooperSurgical, Inc. | 0 |
| 2014-09-23 | VAI | Voluntary action indicated | Lone Star Medical Products, Inc. | 0 |
| 2013-04-25 | WL | Warning Letter | Lone Star Medical Products, Inc. | — |
| 2012-07-11 | WL | Warning Letter | Leisegang Feinmechanick-Optik GmbH | — |
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