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.
20 linked reportsMalfunction 20
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
2.75
2019-02
0
3
2019-03
0
4.67
2019-04
0
2.44
2019-05
0
22
2019-06
0
4.25
2019-07
0
6
2019-08
0
7
2019-09
0
2.2
2019-10
0
1.75
2019-11
0
1.25
2019-12
0
5
2020-01
0
1.5
2020-02
0
2.4
2020-03
0
6
2020-04
0
1.5
2020-05
0
2
2020-06
0
2.4
2020-07
0
3
2020-08
0
5
2020-09
0
1.33
2020-10
0
6
2020-11
0
1.5
2020-12
0
5
2021-01
0
3
2021-02
0
4.5
2021-03
0
8
2021-04
0
5.33
2021-05
0
10.5
2021-06
0
5
2021-07
0
6.67
2021-08
0
5.6
2021-09
0
3.2
2021-10
0
3
2021-11
0
3
2021-12
0
3.67
2022-01
0
2.5
2022-02
0
3.75
2022-03
0
4.5
2022-04
0
3
2022-05
0
4.5
2022-06
0
2.89
2022-07
0
3.75
2022-08
0
3
2022-09
0
2.33
2022-10
0
5.5
2022-11
0
5.2
2022-12
0
2.25
2023-01
0
4.83
2023-02
0
2.67
2023-03
0
3.11
2023-04
0
3.5
2023-05
0
5.17
2023-06
2
3
2023-07
0
3.5
2023-08
0
3.8
2023-09
0
2.89
2023-10
5
2.5
2023-11
3
2.89
2023-12
0
4.11
2024-01
0
2
2024-02
2
3.25
2024-03
0
2.7
2024-04
0
4.09
2024-05
0
2.73
2024-06
0
2.33
2024-07
1
3
2024-08
0
6.67
2024-09
0
2
2024-10
1
4.6
2024-11
0
4.83
2024-12
0
3.8
2025-01
1
1.92
2025-02
0
4.65
2025-03
0
3.43
2025-04
1
1.93
2025-05
0
5.67
2025-06
0
8.5
2025-07
1
1.75
2025-08
0
4
2025-09
0
3
2025-10
1
2.4
2025-11
0
4.5
2025-12
0
2
2026-01
1
2.1
2026-02
0
2.33
2026-03
0
6.5
2026-04
1
1.38
2026-05
0
3
2026-06
0
2
This device (reports/month)Average device in PGW (reports/device/month)
Failure-mode summaryAI-generated
20 linked report narratives available — no AI summary generated yet.
Recall history
Initiated
Recall #
Class
Status
Reason
Quantity
Link basis
2024-04-04
Z-1885-2024
Class II
Open, Classified
Unreleased software was installed on customer systems resulting in the visual feedback on the screen to show the points to be off from the physical reference point of the pointer or suction.Distribution: US Nationwide distribution.