Air/Water Channel Cleaning Brush · 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	3.5
2019-02	0	4.41
2019-03	0	6.44
2019-04	0	6.56
2019-05	0	4.99
2019-06	0	5.42
2019-07	0	6.46
2019-08	0	5.73
2019-09	0	3.63
2019-10	0	3.58
2019-11	0	4.16
2019-12	0	4.28
2020-01	0	2.8
2020-02	0	5.87
2020-03	0	4.53
2020-04	0	4.45
2020-05	0	3.66
2020-06	0	3.86
2020-07	0	6.13
2020-08	0	4.31
2020-09	0	3.92
2020-10	0	5.73
2020-11	0	5.89
2020-12	0	8.05
2021-01	0	8.41
2021-02	0	6.59
2021-03	0	10.26
2021-04	0	7.18
2021-05	0	8.37
2021-06	0	8.48
2021-07	0	9.43
2021-08	0	9.15
2021-09	0	11.71
2021-10	0	7.54
2021-11	0	8.69
2021-12	0	11.64
2022-01	0	9.03
2022-02	0	10.75
2022-03	0	11.36
2022-04	0	11.63
2022-05	0	12.43
2022-06	0	11.53
2022-07	0	10.11
2022-08	0	8.89
2022-09	0	7.97
2022-10	0	7.97
2022-11	0	7.84
2022-12	0	8.62
2023-01	0	8.08
2023-02	0	7.51
2023-03	0	10.39
2023-04	0	7.58
2023-05	0	9.33
2023-06	0	7.22
2023-07	0	7.49
2023-08	0	9.69
2023-09	0	9.22
2023-10	0	10.37
2023-11	0	9.49
2023-12	0	9.23
2024-01	0	10.6
2024-02	0	9.58
2024-03	0	11.44
2024-04	0	10.32
2024-05	1	8.48
2024-06	0	10.47
2024-07	0	9.71
2024-08	0	9.59
2024-09	0	9.43
2024-10	0	11.87
2024-11	0	7.36
2024-12	0	9.26
2025-01	0	6.05
2025-02	0	5.32
2025-03	0	7.07
2025-04	0	5.64
2025-05	0	6.15
2025-06	0	6.22
2025-07	0	6.15
2025-08	0	7.6
2025-09	0	7.27
2025-10	0	12.02
2025-11	0	17.21
2025-12	0	28.18
2026-01	0	21.01
2026-02	0	11.78
2026-03	0	12.68
2026-04	0	18.77
2026-05	0	23.2
2026-06	0	21.39

This device (reports/month)Average device in ITX, IYN, IYO, NWB, ODG (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
2024-05-07	3002808148-2024-04201	Malfunction	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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