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.
3 linked reportsMalfunction 3
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
2.43
2019-02
0
5.57
2019-03
0
3.31
2019-04
0
3.13
2019-05
0
2.6
2019-06
0
3.19
2019-07
0
3.94
2019-08
0
4.13
2019-09
0
3
2019-10
0
2.79
2019-11
0
2.73
2019-12
0
2.76
2020-01
0
2.69
2020-02
0
1.75
2020-03
0
1.7
2020-04
0
1.75
2020-05
0
1.44
2020-06
0
1.39
2020-07
0
2.06
2020-08
0
1.48
2020-09
0
1.25
2020-10
0
3.06
2020-11
0
1.53
2020-12
0
1.79
2021-01
0
2.15
2021-02
0
2.22
2021-03
0
2.89
2021-04
0
2.47
2021-05
0
1.75
2021-06
0
2.65
2021-07
0
2.05
2021-08
0
1.6
2021-09
0
3.04
2021-10
0
1.78
2021-11
0
2
2021-12
0
2.58
2022-01
0
2.38
2022-02
0
2.82
2022-03
0
1.88
2022-04
0
2.11
2022-05
0
2.36
2022-06
0
2.92
2022-07
0
1.96
2022-08
0
2.1
2022-09
2
2.21
2022-10
0
2.57
2022-11
0
2.14
2022-12
1
3.13
2023-01
0
2.1
2023-02
0
2.17
2023-03
0
3
2023-04
0
2.35
2023-05
0
2.76
2023-06
0
2.36
2023-07
0
1.88
2023-08
0
1.79
2023-09
0
2.68
2023-10
0
1.94
2023-11
0
2.17
2023-12
0
2.35
2024-01
0
1.35
2024-02
0
1.86
2024-03
0
1.75
2024-04
0
2.09
2024-05
0
3.09
2024-06
0
1.91
2024-07
0
2.32
2024-08
0
3.94
2024-09
0
1.89
2024-10
0
2.06
2024-11
0
2.13
2024-12
0
2.76
2025-01
0
5.21
2025-02
0
3.16
2025-03
0
2.83
2025-04
0
3.91
2025-05
0
2.41
2025-06
0
4.94
2025-07
0
2.17
2025-08
0
3.29
2025-09
0
3.79
2025-10
0
3.14
2025-11
0
3.13
2025-12
0
3.77
2026-01
0
2.56
2026-02
0
8.61
2026-03
0
3.67
2026-04
0
3.26
2026-05
0
4.78
2026-06
0
2.43
This device (reports/month)Average device in FBK, FCG (reports/device/month)
Failure-mode summaryAI-generated
3 linked report narratives available — no AI summary generated yet.
Recall history
Initiated
Recall #
Class
Status
Reason
Quantity
Link basis
2016-05-18
Z-0289-2017
Class II
Terminated
US Endoscopy is conducting a voluntary product recall of one lot of the Vari-Safe Injection Needle as it was identified that the lot was incorrectly distributed. The lot was assembled with internal catheter components which differ from the original Vari-Safe needle internal catheter components. All components are dimensionally similar to the original Vari-Safe needle internal catheter components and the components have history of use on other US Endoscopy needle products.Distribution: US Distribution to the states of : OH, OR, WA and Internationally to the country of Italy.
36 units
clearance family
Individual MAUDE reports
Date
Report #
Type
Narrative
Link basis
2022-12-13
1528319-2022-00064
Malfunction
Available
exact di
2022-09-27
1528319-2022-00045
Malfunction
Available
exact di
2022-09-27
1528319-2022-00046
Malfunction
Available
exact di
Regulatory clearances
510(k)K232826Substantially equivalent (SESE) · 2024-03-08clearance family
Lineage each submission cites, walked transitively (indented = the cited device's own predicates). Extracted from public 510(k) summary text — heuristic, and includes reference devices mentioned alongside true predicates.