Genesys HTA ProCerva · recalls, adverse events, clearances

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.

87 linked reportsInjury 57Malfunction 30

Monthly adverse-event reports for this device versus the product-code average.
Month	This device (reports)	Product-code average (reports per device)
2019-01	2	2.29
2019-02	3	3
2019-03	4	4.43
2019-04	1	3.67
2019-05	3	5.83
2019-06	0	1.75
2019-07	3	4.17
2019-08	0	5
2019-09	1	2.57
2019-10	1	4.22
2019-11	3	4.25
2019-12	1	2.5
2020-01	1	2.78
2020-02	0	3.2
2020-03	0	2.43
2020-04	0	2.17
2020-05	0	3.33
2020-06	0	2.5
2020-07	0	2.71
2020-08	0	3.5
2020-09	2	4.86
2020-10	0	2.83
2020-11	0	3.6
2020-12	0	8
2021-01	0	2.67
2021-02	0	4
2021-03	0	8.2
2021-04	6	6.5
2021-05	0	7.8
2021-06	3	8
2021-07	0	4.83
2021-08	0	8.67
2021-09	6	3.71
2021-10	2	4
2021-11	0	13
2021-12	0	13.75
2022-01	0	4.33
2022-02	3	2.17
2022-03	0	5.83
2022-04	0	2.25
2022-05	3	2.5
2022-06	0	3.43
2022-07	0	5.5
2022-08	0	7.75
2022-09	0	3.4
2022-10	0	5.43
2022-11	0	4.63
2022-12	0	11.2
2023-01	0	5.83
2023-02	6	3.71
2023-03	11	5.57
2023-04	1	7.2
2023-05	5	5.6
2023-06	0	6.17
2023-07	0	5.75
2023-08	1	6
2023-09	1	3.22
2023-10	0	4
2023-11	1	5.44
2023-12	0	7
2024-01	1	4.22
2024-02	0	12.75
2024-03	0	6.17
2024-04	0	3.8
2024-05	1	10.5
2024-06	0	3.71
2024-07	0	2.75
2024-08	0	2.33
2024-09	2	5.67
2024-10	0	3.8
2024-11	0	5.5
2024-12	0	3
2025-01	2	4.56
2025-02	0	4.67
2025-03	0	6.33
2025-04	0	5.14
2025-05	0	7.25
2025-06	1	6.14
2025-07	2	3
2025-08	0	9
2025-09	0	4.17
2025-10	0	4
2025-11	0	3
2025-12	0	5.33
2026-01	2	5.5
2026-02	0	4.4
2026-03	0	11
2026-04	0	4.5
2026-05	2	2.33
2026-06	0	8.5

This device (reports/month)Average device in MNB (reports/device/month)

Failure-mode summaryAI-generated

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

Recall history

No recalls linked.

Individual MAUDE reports

Date	Report #	Type	Narrative	Link basis
2026-05-05	3011011193-2026-00006	Injury	Available	catalog number
2026-01-30	3011011193-2026-00002	Injury	Available	catalog number
2025-07-02	3011011193-2025-00010	Injury	Available	catalog number
2025-06-18	3011011193-2025-00009	Injury	Available	exact di
2025-01-08	3011011193-2025-00001	Injury	Available	catalog number
2024-09-19	3011011193-2024-00013	Injury	Available	catalog number
2024-05-17	3011011193-2024-00010	Injury	Available	catalog number
2024-01-12	3011011193-2024-00003	Injury	Available	catalog number
2023-11-29	3011011193-2023-00028	Injury	Available	catalog number
2023-09-11	MW5145528	Injury	Available	catalog number
2023-08-04	3011011193-2023-00021	Injury	Available	catalog number
2023-05-19	3011011193-2023-00017	Malfunction	Available	catalog number
2023-05-19	3011011193-2023-00018	Malfunction	Available	catalog number
2023-05-16	3011011193-2023-00016	Malfunction	Available	catalog number
2023-04-28	3011011193-2023-00015	Malfunction	Available	catalog number

Showing the most recent 55 of 87 linked reports.

Showing 1–15 of 55

Regulatory clearances

None linked.

Manufacturer compliance record

Date	Type	Outcome	Facility
2021-07-14	NAI	No action indicated	Minerva Surgical Incorporated
2021-07-14	NAI	No action indicated	Minerva Surgical Incorporated
2016-08-30	NAI	No action indicated	Minerva Surgical Incorporated
2016-08-30	NAI	No action indicated	Minerva Surgical Incorporated
2015-02-27	NAI	No action indicated	Minerva Surgical Incorporated
2015-02-27	NAI	No action indicated	Minerva Surgical Incorporated
2014-11-07	NAI	No action indicated	Minerva Surgical Incorporated
2014-11-07	NAI	No action indicated	Minerva Surgical Incorporated

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