CRADLE · 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 reportsInjury 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	1.4
2019-02	0	1.29
2019-03	0	1.33
2019-04	0	2
2019-06	0	1.33
2019-07	0	1.25
2019-09	0	1
2019-10	0	1
2019-11	0	1
2019-12	0	2.5
2020-01	0	1
2020-03	0	1.67
2020-05	0	1
2020-07	0	1
2020-09	0	1
2020-10	0	1
2021-01	0	1
2021-03	0	1
2021-05	0	1
2021-06	0	2.33
2021-07	0	1.4
2021-08	0	1
2021-09	0	1
2021-10	0	1
2021-11	0	1
2022-03	0	1
2022-04	0	1.2
2022-05	0	2.5
2022-07	0	1
2022-08	0	1
2022-09	0	2
2022-10	0	2.67
2022-11	0	1
2023-01	0	1
2023-03	0	1.67
2023-04	0	1.5
2023-05	0	1
2023-06	2	1.5
2023-07	0	2
2023-09	0	1
2023-10	0	2
2023-11	0	1
2023-12	0	1
2024-02	0	1.5
2024-03	0	1
2024-04	0	2
2024-05	0	1
2024-06	0	14.5
2024-07	0	15
2024-08	0	4.33
2024-09	0	9.5
2024-10	0	3.8
2024-11	0	2.33
2024-12	0	4.67
2025-01	0	2.33
2025-02	0	2
2025-03	0	1
2025-04	0	2
2025-05	0	4.33
2025-06	0	3
2025-07	0	3.67
2025-08	0	2
2025-09	0	2
2025-10	0	3.33
2025-11	0	2.67
2025-12	0	3.25
2026-01	0	1.5
2026-02	0	1
2026-03	0	5
2026-04	0	1.25
2026-05	0	1
2026-06	0	1.33

This device (reports/month)Average device in NEZ (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
2023-06-21	3002808148-2023-06259	Injury	Available	exact di
2023-06-21	2429304-2023-00197	Injury	Available	exact di

Regulatory clearances

None linked.

Manufacturer compliance record

Date	Type	Outcome	Facility	Citations
2022-12-12	WL	Warning Letter	Olympus Medical Systems Corporation	—
2022-09-09	OAI	Official action indicated	Olympus Medical Systems Corporation	1
2018-03-09	WL	Warning Letter	Olympus Medical Systems Corporation	—
2015-04-24	OAI	Official action indicated	Olympus Medical Systems Corporation	2

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