Genesys HTA Control Unit · 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.

23 linked reportsMalfunction 19Injury 4

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

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

Failure-mode summaryAI-generated

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

Recall history

No recalls linked.

Individual MAUDE reports

Date	Report #	Type	Narrative	Link basis
2023-11-03	MW5147807	Injury	Available	model number
2020-11-20	3005099803-2020-05194	Malfunction	Available	exact di
2020-10-23	3005099803-2020-04721	Malfunction	Available	exact di
2020-09-29	3005099803-2020-04286	Malfunction	Available	exact di
2020-09-28	3005099803-2020-04284	Malfunction	Available	exact di
2020-09-25	3005099803-2020-04245	Injury	Available	exact di
2020-09-09	3005099803-2020-03850	Malfunction	Available	exact di
2020-09-08	3005099803-2020-03691	Malfunction	Available	exact di
2020-08-19	3005099803-2020-03449	Malfunction	Available	exact di
2020-08-10	3005099803-2020-03139	Malfunction	Available	exact di
2020-07-27	3005099803-2020-02990	Malfunction	Available	exact di
2020-04-14	3005099803-2020-01632	Malfunction	Available	exact di
2020-03-11	3005099803-2020-00858	Malfunction	Available	exact di
2019-12-23	3005099803-2019-06252	Malfunction	Available	exact di
2019-12-11	3005099803-2019-05918	Injury	Available	exact di

Showing 1–15 of 23

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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