Articulating arm · 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.

2 linked reportsMalfunction 2

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	5
2019-02	0	2.69
2019-03	0	3.36
2019-04	0	5.52
2019-05	2	3.06
2019-06	0	3.69
2019-07	0	2.65
2019-08	0	2.92
2019-09	0	2.14
2019-10	0	3.42
2019-11	0	2.1
2019-12	0	4.78
2020-01	0	2
2020-02	0	2.6
2020-03	0	2.13
2020-04	0	4.5
2020-05	0	2.1
2020-06	0	2.31
2020-07	0	3.27
2020-08	0	3.1
2020-09	0	2.4
2020-10	0	2.61
2020-11	0	3.52
2020-12	0	3.16
2021-01	0	2
2021-02	0	2.96
2021-03	0	2.91
2021-04	0	3.45
2021-05	0	4.56
2021-06	0	5.37
2021-07	0	3.62
2021-08	0	4.54
2021-09	0	2.88
2021-10	0	2.47
2021-11	0	3.56
2021-12	0	4.09
2022-01	0	3.43
2022-02	0	3.71
2022-03	0	4.36
2022-04	0	3.48
2022-05	0	4
2022-06	0	1.93
2022-07	0	3.24
2022-08	0	1.8
2022-09	0	2.7
2022-10	0	2.07
2022-11	0	1.86
2022-12	0	1.86
2023-01	0	2.04
2023-02	0	2.22
2023-03	0	2.82
2023-04	0	2
2023-05	0	2.52
2023-06	0	6.36
2023-07	0	2.1
2023-08	0	3.2
2023-09	0	2.68
2023-10	0	4.44
2023-11	0	2.54
2023-12	0	2.68
2024-01	0	1.92
2024-02	0	1.79
2024-03	0	1.68
2024-04	0	1.63
2024-05	0	2.46
2024-06	0	2.53
2024-07	0	2.28
2024-08	0	1.75
2024-09	0	1.27
2024-10	0	3.48
2024-11	0	3.33
2024-12	0	3.19
2025-01	0	3.28
2025-02	0	2.92
2025-03	0	3.18
2025-04	0	3.17
2025-05	0	4.56
2025-06	0	3.67
2025-07	0	3.1
2025-08	0	3.07
2025-09	0	3.53
2025-10	0	3.45
2025-11	0	4.5
2025-12	0	4.17
2026-01	0	6.89
2026-02	0	3.84
2026-03	0	5.65
2026-04	0	3.93
2026-05	0	5.15
2026-06	0	2.9

This device (reports/month)Average device in DSB, IZQ, JAK (reports/device/month)

Failure-mode summaryAI-generated

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

Recall history

No recalls linked.

Individual MAUDE reports

Date	Report #	Type	Narrative	Link basis
2019-05-24	3004753774-2019-00001	Malfunction	Available	catalog number

Showing the most recent 1 of 2 linked reports.

Regulatory clearances

None linked.

Manufacturer compliance record

Date	Type	Outcome	Facility	Citations
2017-02-01	NAI	No action indicated	Bracco Injeneering S.A.	0

Similar devices