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.
6 linked reportsMalfunction 6
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
3.67
2019-03
0
1.67
2019-04
0
2
2019-05
0
2.11
2019-06
0
1.29
2019-07
0
2.8
2019-08
0
1.78
2019-09
0
1.13
2019-10
0
1.5
2019-11
0
1.2
2019-12
0
2
2020-01
0
1
2020-02
0
2.5
2020-03
0
3.14
2020-04
0
6.2
2020-05
0
6.8
2020-06
0
6.63
2020-07
0
10.57
2020-08
2
8.78
2020-09
0
20.25
2020-10
0
11.43
2020-11
0
17
2020-12
0
16
2021-01
0
8.89
2021-02
0
16.5
2021-03
0
40.2
2021-04
0
21.3
2021-05
0
15.25
2021-06
2
9.83
2021-07
0
20.57
2021-08
0
15.5
2021-09
0
10.67
2021-10
0
7.82
2021-11
0
14.17
2021-12
0
16.25
2022-01
0
8.09
2022-02
0
15.25
2022-03
0
9.5
2022-04
0
9.45
2022-05
0
18.33
2022-06
0
21.83
2022-07
0
9.75
2022-08
0
9.86
2022-09
0
8.7
2022-10
0
8.67
2022-11
0
5.44
2022-12
0
7.58
2023-01
0
8.12
2023-02
0
13
2023-03
0
9.13
2023-04
0
5.61
2023-05
0
7.5
2023-06
0
6.74
2023-07
0
11.43
2023-08
0
8
2023-09
0
11.67
2023-10
0
9.53
2023-11
0
10.6
2023-12
0
12.38
2024-01
0
20.36
2024-02
0
10.35
2024-03
0
10.85
2024-04
0
10.73
2024-05
0
8.69
2024-06
0
11.31
2024-07
0
7.59
2024-08
0
10.64
2024-09
0
11.29
2024-10
0
11.72
2024-11
0
5.7
2024-12
0
3
2025-01
0
5.44
2025-02
0
3.73
2025-03
0
5.86
2025-04
0
4.13
2025-05
0
4.36
2025-06
0
5.88
2025-07
0
4.36
2025-08
0
7
2025-09
0
9.29
2025-10
0
8.62
2025-11
0
13.82
2025-12
0
23.25
2026-01
0
25.15
2026-02
0
17.9
2026-03
0
17.63
2026-04
0
39.14
2026-05
0
42.36
2026-06
2
43
This device (reports/month)Average device in FEB (reports/device/month)
Failure-mode summaryAI-generated
6 linked report narratives available — no AI summary generated yet.
Recall history
No recalls linked.
Individual MAUDE reports
Date
Report #
Type
Narrative
Link basis
2026-06-03
9610595-2026-45464
Malfunction
Available
exact di
2026-06-02
9610595-2026-44803
Malfunction
Available
exact di
2021-06-28
8010047-2021-08069
Malfunction
Available
exact di
2020-08-03
8010047-2020-05215
Malfunction
Available
exact di
Showing the most recent 4 of 6 linked reports.
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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