Advincula Arch Reusable Manipulator Handle · 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.

1 linked reportMalfunction 1

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
2019-02	0	1.8
2019-03	0	4.33
2019-04	0	4.33
2019-05	0	4.67
2019-06	0	3.5
2019-07	0	2
2019-08	0	3.67
2019-09	0	2
2019-10	0	3.5
2019-11	0	1
2019-12	0	1.67
2020-01	0	2.4
2020-02	0	2
2020-03	0	3.8
2020-04	0	2.83
2020-05	0	1
2020-06	0	4.5
2020-07	0	4
2020-08	0	1.71
2020-09	0	3.75
2020-10	0	4
2020-11	0	7
2020-12	0	2.17
2021-01	0	2.2
2021-02	0	4
2021-03	0	4.5
2021-04	0	3.6
2021-05	0	3.17
2021-06	0	6
2021-07	0	13
2021-08	0	4.25
2021-09	0	6
2021-10	0	1.67
2021-11	0	3.5
2021-12	0	7.5
2022-01	0	1
2022-02	0	2.5
2022-03	0	4.25
2022-04	0	2.75
2022-05	0	2.67
2022-06	0	2.5
2022-07	0	4.33
2022-08	1	2.25
2022-09	0	2
2022-10	0	2.5
2022-11	0	2.67
2022-12	0	2
2023-01	0	6.5
2023-02	0	1.8
2023-03	0	2
2023-04	0	1.5
2023-05	0	7.5
2023-06	0	1.75
2023-07	0	2
2023-08	0	1.8
2023-09	0	1.33
2023-10	0	2
2023-11	0	2.33
2023-12	0	2
2024-01	0	4
2024-02	0	2.83
2024-03	0	1.67
2024-04	0	3.33
2024-05	0	1.67
2024-06	0	1
2024-07	0	2.75
2024-08	0	4.33
2024-09	0	8
2024-10	0	3
2024-11	0	3.33
2024-12	0	3
2025-01	0	4.33
2025-02	0	3.67
2025-03	0	1.5
2025-04	0	3
2025-05	0	3
2025-06	0	2.67
2025-07	0	3
2025-08	0	1
2025-09	0	2
2025-10	0	2.67
2025-11	0	3.67
2025-12	0	2.25
2026-01	0	3.67
2026-02	0	3
2026-03	0	3.5
2026-04	0	2.5
2026-05	0	16
2026-06	0	3.33

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

Failure-mode summaryAI-generated

1 linked report narrative available — no AI summary generated yet.

Recall history

No recalls linked.

Individual MAUDE reports

Date	Report #	Type	Narrative	Link basis
2022-08-10	1216677-2022-00224	Malfunction	Available	model number

Regulatory clearances

None linked.

Manufacturer compliance record

Date	Type	Outcome	Facility	Citations
2024-02-01	VAI	Voluntary action indicated	CooperSurgical, Inc.	0
2023-05-16	NAI	No action indicated	CooperSurgical, Inc.	0
2023-05-16	NAI	No action indicated	CooperSurgical, Inc.	0
2023-04-27	VAI	Voluntary action indicated	Lone Star Medical Products, Inc.	5
2022-12-15	NAI	No action indicated	Leisegang Feinmechanick-Optik GmbH	0
2021-07-15	VAI	Voluntary action indicated	CooperSurgical, Inc.	4
2021-07-15	VAI	Voluntary action indicated	CooperSurgical, Inc.	4
2019-08-01	NAI	No action indicated	CooperSurgical, Inc.	2
2018-05-02	NAI	No action indicated	Lone Star Medical Products, Inc.	0
2017-12-07	NAI	No action indicated	CooperSurgical, Inc.	0
2017-12-07	NAI	No action indicated	CooperSurgical, Inc.	0
2017-05-04	NAI	No action indicated	Lone Star Medical Products, Inc.	0
2016-03-31	NAI	No action indicated	CooperSurgical, Inc.	0
2016-03-31	NAI	No action indicated	CooperSurgical, Inc.	0
2015-12-10	NAI	No action indicated	Leisegang Feinmechanick-Optik GmbH	0
2015-06-09	WL	Warning Letter	CooperSurgical, Inc.	—
2015-06-09	WL	Warning Letter	CooperSurgical, Inc.	—
2014-12-17	OAI	Official action indicated	CooperSurgical, Inc.	8
2014-12-17	OAI	Official action indicated	CooperSurgical, Inc.	8
2014-12-01	NAI	No action indicated	CooperSurgical, Inc.	0
2014-12-01	NAI	No action indicated	CooperSurgical, Inc.	0
2014-09-23	VAI	Voluntary action indicated	Lone Star Medical Products, Inc.	0
2013-04-25	WL	Warning Letter	Lone Star Medical Products, Inc.	—
2012-07-11	WL	Warning Letter	Leisegang Feinmechanick-Optik GmbH	—

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