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.
93 linked reportsMalfunction 84Injury 9
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-02 | 20 | 20 |
| 2019-03 | 1 | 1 |
| 2019-04 | 1 | 1 |
| 2019-05 | 1 | 1 |
| 2019-08 | 0 | 1 |
| 2019-09 | 0 | 1 |
| 2019-10 | 0 | 1 |
| 2020-02 | 19 | 19 |
| 2020-08 | 1 | 1 |
| 2020-09 | 1 | 1 |
| 2020-12 | 2 | 2 |
| 2021-01 | 1 | 1 |
| 2021-04 | 7 | 7 |
| 2021-07 | 1 | 1 |
| 2021-12 | 1 | 1 |
| 2022-03 | 1 | 1 |
| 2022-04 | 0 | 1 |
| 2022-07 | 1 | 1 |
| 2022-08 | 1 | 1 |
| 2022-11 | 1 | 1 |
| 2022-12 | 2 | 2 |
| 2023-01 | 0 | 1 |
| 2023-02 | 6 | 3.5 |
| 2023-03 | 1 | 1 |
| 2023-06 | 1 | 1 |
| 2023-08 | 1 | 1 |
| 2023-09 | 1 | 1 |
| 2023-11 | 0 | 1 |
| 2024-03 | 0 | 1 |
| 2024-05 | 0 | 4 |
| 2024-07 | 0 | 1 |
| 2024-10 | 3 | 3 |
| 2025-04 | 0 | 1 |
| 2025-11 | 3 | 3 |
| 2026-01 | 3 | 3 |
| 2026-03 | 9 | 9 |
| 2026-04 | 3 | 3 |
Failure-mode summaryAI-generated
40 linked report narratives available — no AI summary generated yet.
Recall history
| Initiated | Recall # | Class | Status | Reason | Quantity | Link basis |
|---|---|---|---|---|---|---|
| 2022-10-20 | Z-0223-2023 | Class II | Open, Classified | Firm has received 11 complaints involving a loose or detached metal clips, including 3 cases where the metal clip was ingested by the patient, and 3 cases where the metal clip was removed from the patient's mouth. In one case, the patient suffered a laceration to the throat.Distribution: Worldwide distribution: US (Nationwide) including Puerto Rico; and countries (foreign) of: Australia, Bahrain, Belgium, Bulgaria, Canada, Colombia, Cyprus, Ecuador, Germany, Greece, Hong Kong, Hungary, India, Ireland, Italy, Malaysia, Malta, Netherlands, New Zealand, Saudi Arabia, Singapore, Turkey, Philippines, Qatar, United Arab Emirates, and United Kingdom. | 220,500 devices | code info di |
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2026-04-08 | 1216677-2026-00030 | Malfunction | Available | exact di |
| 2026-03-23 | 1216677-2026-00023 | Injury | Available | exact di |
| 2026-03-23 | 1216677-2026-00021 | Injury | Available | exact di |
| 2026-03-23 | 1216677-2026-00022 | Injury | Available | exact di |
| 2026-01-06 | 1216677-2026-00001 | Malfunction | Available | exact di |
| 2025-11-03 | 1216677-2025-00049 | Malfunction | Available | exact di |
| 2024-10-02 | 1216677-2024-00058 | Malfunction | Available | exact di |
| 2023-09-05 | MW5145190 | Malfunction | Available | model number |
| 2023-08-09 | 1216677-2023-00117 | Malfunction | Available | model number |
| 2023-06-14 | 1216677-2023-00095 | Malfunction | Available | model number |
| 2023-03-17 | 1216677-2023-00049 | Malfunction | Available | model number |
| 2023-02-02 | 1216677-2023-00018 | Malfunction | Available | model number |
| 2023-02-02 | 1216677-2023-00017 | Malfunction | Available | model number |
| 2023-02-02 | 1216677-2023-00019 | Malfunction | Available | model number |
| 2023-02-02 | 1216677-2023-00020 | Malfunction | Available | model number |
Showing the most recent 78 of 93 linked reports.
Showing 1–15 of 78
Regulatory clearances
None linked.
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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