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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.

12 linked reportsMalfunction 12
12232019-01: 2 reports for this device; peer average 2/device2019-07: 1 reports for this device; peer average 1/device2019-08: 1 reports for this device; peer average 1/device2019-09: 1 reports for this device; peer average 1/device2020-08: 0 reports for this device; peer average 1/device2020-09: 0 reports for this device; peer average 1/device2021-03: 0 reports for this device; peer average 1/device2021-05: 0 reports for this device; peer average 1/device2021-06: 0 reports for this device; peer average 1/device2021-10: 2 reports for this device; peer average 1.5/device2021-11: 1 reports for this device; peer average 1/device2021-12: 3 reports for this device; peer average 3/device2023-01: 1 reports for this device; peer average 1/device01070809080903050610111201
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0122
2019-0711
2019-0811
2019-0911
2020-0801
2020-0901
2021-0301
2021-0501
2021-0601
2021-1021.5
2021-1111
2021-1233
2023-0111
This device (reports/month)Average device in HQA (reports/device/month)
Failure-mode summaryAI-generated

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

Recall history

No recalls linked.

Individual MAUDE reports
DateReport #TypeNarrativeLink basis
2023-01-131216677-2022-00346MalfunctionAvailablemodel number
2021-12-281216677-2021-00307MalfunctionAvailablemodel number
2021-12-171216677-2021-00292MalfunctionAvailablemodel number
2021-12-171216677-2021-00291MalfunctionAvailablemodel number
2021-11-161216677-2021-00261MalfunctionAvailablemodel number
2021-10-021216677-2021-00211MalfunctionAvailableexact di
2019-09-301216677-2019-00268MalfunctionAvailablemodel number
2019-08-211216677-2019-00230MalfunctionAvailablemodel number
2019-07-011216677-2019-00186MalfunctionAvailablemodel number
2019-01-021216677-2018-00095MalfunctionAvailablemodel number
2019-01-021216677-2018-00092MalfunctionAvailablemodel number

Showing the most recent 11 of 12 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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