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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.

19 linked reportsInjury 18Malfunction 1
24682019-09: 0 reports for this device; peer average 1/device2019-10: 0 reports for this device; peer average 2/device2022-07: 0 reports for this device; peer average 3/device2022-09: 1 reports for this device; peer average 1/device2023-04: 0 reports for this device; peer average 6/device2023-07: 0 reports for this device; peer average 4.67/device2023-08: 0 reports for this device; peer average 3.33/device2023-10: 6 reports for this device; peer average 5/device2023-12: 4 reports for this device; peer average 4/device2024-08: 0 reports for this device; peer average 4/device2025-05: 8 reports for this device; peer average 8/device2026-06: 0 reports for this device; peer average 2/device091007090407081012080506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0901
2019-1002
2022-0703
2022-0911
2023-0406
2023-0704.67
2023-0803.33
2023-1065
2023-1244
2024-0804
2025-0588
2026-0602
This device (reports/month)Average device in MQE (reports/device/month)
Failure-mode summaryAI-generated

19 linked report narratives available — no AI summary generated yet.

Recall history

No recalls linked.

Individual MAUDE reports
DateReport #TypeNarrativeLink basis
2025-05-081216677-2025-00024InjuryAvailableexact di
2025-05-081216677-2025-00025InjuryAvailableexact di
2025-05-081216677-2025-00026InjuryAvailableexact di
2025-05-081216677-2025-00023InjuryAvailableexact di
2023-12-141216677-2023-00161InjuryAvailableexact di
2023-12-141216677-2023-00160InjuryAvailableexact di
2023-10-251216677-2023-00139InjuryAvailableexact di
2023-10-251216677-2023-00141InjuryAvailableexact di
2023-10-251216677-2023-00140InjuryAvailableexact di
2022-09-041216677-2022-00255MalfunctionAvailablemodel number

Showing the most recent 10 of 19 linked reports.

Regulatory clearances

None linked.

Manufacturer compliance record
DateTypeOutcomeFacilityCitations
2024-02-01VAIVoluntary action indicatedCooperSurgical, Inc.0
2023-05-16NAINo action indicatedCooperSurgical, Inc.0
2023-05-16NAINo action indicatedCooperSurgical, Inc.0
2023-04-27VAIVoluntary action indicatedLone Star Medical Products, Inc.5
2022-12-15NAINo action indicatedLeisegang Feinmechanick-Optik GmbH0
2021-07-15VAIVoluntary action indicatedCooperSurgical, Inc.4
2021-07-15VAIVoluntary action indicatedCooperSurgical, Inc.4
2019-08-01NAINo action indicatedCooperSurgical, Inc.2
2018-05-02NAINo action indicatedLone Star Medical Products, Inc.0
2017-12-07NAINo action indicatedCooperSurgical, Inc.0
2017-12-07NAINo action indicatedCooperSurgical, Inc.0
2017-05-04NAINo action indicatedLone Star Medical Products, Inc.0
2016-03-31NAINo action indicatedCooperSurgical, Inc.0
2016-03-31NAINo action indicatedCooperSurgical, Inc.0
2015-12-10NAINo action indicatedLeisegang Feinmechanick-Optik GmbH0
2015-06-09WLWarning LetterCooperSurgical, Inc.—
2015-06-09WLWarning LetterCooperSurgical, Inc.—
2014-12-17OAIOfficial action indicatedCooperSurgical, Inc.8
2014-12-17OAIOfficial action indicatedCooperSurgical, Inc.8
2014-12-01NAINo action indicatedCooperSurgical, Inc.0
2014-12-01NAINo action indicatedCooperSurgical, Inc.0
2014-09-23VAIVoluntary action indicatedLone Star Medical Products, Inc.0
2013-04-25WLWarning LetterLone Star Medical Products, Inc.—
2012-07-11WLWarning LetterLeisegang Feinmechanick-Optik GmbH—
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