ROSA® Brain · 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.

59 linked reportsMalfunction 46Injury 13

Monthly adverse-event reports for this device versus the product-code average.
Month	This device (reports)	Product-code average (reports per device)
2019-01	1	12.92
2019-02	3	14.35
2019-03	4	14.05
2019-04	3	18.63
2019-05	3	19.54
2019-06	0	20.19
2019-07	0	13.37
2019-08	4	11.15
2019-09	0	11.95
2019-10	5	9.58
2019-11	12	11.88
2019-12	17	14.46
2020-01	4	11.27
2020-02	2	12.22
2020-03	0	12.88
2020-04	1	10.44
2020-05	0	15.5
2020-06	0	12.21
2020-07	0	14.34
2020-08	0	12.98
2020-09	0	12.31
2020-10	0	12.61
2020-11	0	14.12
2020-12	0	12.64
2021-01	0	11.89
2021-02	0	14.14
2021-03	0	13.25
2021-04	0	13.21
2021-05	0	14.8
2021-06	0	18.26
2021-07	0	13.79
2021-08	0	17.29
2021-09	0	24.68
2021-10	0	14.32
2021-11	0	16.72
2021-12	0	12.67
2022-01	0	10.59
2022-02	0	13.53
2022-03	0	15.09
2022-04	0	12.75
2022-05	0	16.55
2022-06	0	15.68
2022-07	0	12.74
2022-08	0	13.73
2022-09	0	15.67
2022-10	0	18.18
2022-11	0	16.94
2022-12	0	16.56
2023-01	0	14
2023-02	0	12.62
2023-03	0	16.68
2023-04	0	14.38
2023-05	0	16.67
2023-06	0	24.22
2023-07	0	25.39
2023-08	0	21.23
2023-09	0	17.03
2023-10	0	17.29
2023-11	0	18.43
2023-12	0	20.54
2024-01	0	25.65
2024-02	0	20.49
2024-03	0	21.69
2024-04	0	22.32
2024-05	0	18.44
2024-06	0	19.81
2024-07	0	23.6
2024-08	0	29.73
2024-09	0	22.75
2024-10	0	27.4
2024-11	0	14.37
2024-12	0	16.74
2025-01	0	16.27
2025-02	0	21.38
2025-03	0	25.24
2025-04	0	23.34
2025-05	0	20.44
2025-06	0	33.41
2025-07	0	20.35
2025-08	0	17.63
2025-09	0	19.99
2025-10	0	18.6
2025-11	0	16.83
2025-12	0	15.93
2026-01	0	17
2026-02	0	14.12
2026-03	0	15.06
2026-04	0	11.52
2026-05	0	11.51
2026-06	0	8.95

This device (reports/month)Average device in HAW (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
2020-04-10	3009185973-2020-00124	Malfunction	Available	catalog number
2020-02-14	3009185973-2020-00047	Malfunction	Available	catalog number
2020-02-11	3009185973-2020-00043	Malfunction	Available	catalog number
2020-01-15	3009185973-2020-00005	Malfunction	Available	catalog number
2020-01-15	3009185973-2020-00008	Malfunction	Available	catalog number
2020-01-13	3009185973-2020-00003	Malfunction	Available	catalog number
2020-01-06	3009185973-2019-00466	Injury	Available	catalog number
2019-12-30	3009185973-2019-00463	Malfunction	Available	catalog number
2019-12-19	9494826	Malfunction	Available	catalog number
2019-12-19	3009185973-2019-00460	Injury	Available	catalog number
2019-12-19	3009185973-2019-00456	Malfunction	Available	catalog number
2019-12-17	3009185973-2019-00450	Malfunction	Available	catalog number
2019-12-13	3009185973-2019-00446	Malfunction	Available	catalog number
2019-12-13	3009185973-2019-00443	Malfunction	Available	catalog number
2019-12-12	3009185973-2019-00441	Injury	Available	catalog number

Showing 1–15 of 59

Regulatory clearances

None linked.

Manufacturer compliance record

Date	Type	Outcome	Facility	Citations
2022-06-30	VAI	Voluntary action indicated	Medtech LLC	1
2022-06-30	VAI	Voluntary action indicated	Medtech LLC	1

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