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.
11 linked reportsMalfunction 11
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
6.83
2019-02
0
4.34
2019-03
0
4.43
2019-04
0
6.12
2019-05
0
4.77
2019-06
0
5.03
2019-07
0
5.84
2019-08
0
6.07
2019-09
0
4.98
2019-10
0
5.82
2019-11
0
5.57
2019-12
0
5.36
2020-01
0
4.83
2020-02
0
5.55
2020-03
0
5.66
2020-04
0
3.57
2020-05
0
3.76
2020-06
0
5.14
2020-07
0
6.53
2020-08
0
4.61
2020-09
0
5.79
2020-10
0
5.55
2020-11
0
5.12
2020-12
0
5.29
2021-01
0
5.16
2021-02
0
4.89
2021-03
0
5.68
2021-04
0
5.24
2021-05
0
5.14
2021-06
0
5.83
2021-07
0
4.89
2021-08
0
4.3
2021-09
0
4.77
2021-10
0
6.11
2021-11
0
5.57
2021-12
0
5.56
2022-01
0
5.04
2022-02
0
5.14
2022-03
0
5.72
2022-04
1
4.96
2022-05
0
5.76
2022-06
0
6.25
2022-07
0
4.36
2022-08
0
4.57
2022-09
0
4.96
2022-10
0
4.73
2022-11
0
4.56
2022-12
0
4.02
2023-01
0
5.5
2023-02
0
4.54
2023-03
0
4.87
2023-04
0
4.78
2023-05
0
5.14
2023-06
0
4.75
2023-07
1
4.75
2023-08
0
4.42
2023-09
0
5.16
2023-10
0
5.07
2023-11
0
4.36
2023-12
1
4.84
2024-01
1
5.47
2024-02
0
5.4
2024-03
0
6.12
2024-04
1
5.98
2024-05
0
6.15
2024-06
0
5.44
2024-07
0
5.15
2024-08
0
5.06
2024-09
0
5.29
2024-10
0
5.88
2024-11
3
5.19
2024-12
0
4.03
2025-01
0
5.14
2025-02
0
4.44
2025-03
0
6.24
2025-04
0
4.28
2025-05
0
5.1
2025-06
0
5.08
2025-07
0
5.21
2025-08
0
5.39
2025-09
0
4.65
2025-10
0
5.05
2025-11
0
5.61
2025-12
3
5.78
2026-01
0
5.32
2026-02
0
5.9
2026-03
0
6.1
2026-04
0
5.49
2026-05
0
6.15
2026-06
0
5.48
This device (reports/month)Average device in FEQ, GEI (reports/device/month)
Failure-mode summaryAI-generated
11 linked report narratives available — no AI summary generated yet.
Recall history
Initiated
Recall #
Class
Status
Reason
Quantity
Link basis
2022-10-17
Z-0241-2023
Class II
Terminated
Two electronic diode components (D1 & D4) placed in the reverse orientation on the controller printed circuit board assembly may result in premature wear of the power regulator, leading to the regulators failure which could cause a full power loss. If the regulator failure were to occur during a patient procedure, a procedural delay may resultDistribution: US Nationwide distribution in the states of Arizona, Illinois, Tennessee, Virginia.