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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.

10 linked reportsMalfunction 10
12342019-01: 0 reports for this device; peer average 2/device2019-03: 0 reports for this device; peer average 3/device2019-04: 0 reports for this device; peer average 2/device2019-07: 0 reports for this device; peer average 2/device2019-08: 0 reports for this device; peer average 4/device2019-10: 1 reports for this device; peer average 1/device2020-01: 1 reports for this device; peer average 1/device2020-02: 1 reports for this device; peer average 1/device2020-04: 1 reports for this device; peer average 1/device2020-06: 0 reports for this device; peer average 2/device2020-11: 2 reports for this device; peer average 2/device2020-12: 2 reports for this device; peer average 2/device2021-05: 1 reports for this device; peer average 1/device2021-06: 0 reports for this device; peer average 1/device2021-08: 1 reports for this device; peer average 1/device2021-10: 0 reports for this device; peer average 2/device2021-11: 0 reports for this device; peer average 4/device2023-11: 0 reports for this device; peer average 2/device2024-03: 0 reports for this device; peer average 2/device2024-04: 0 reports for this device; peer average 2/device2025-01: 0 reports for this device; peer average 1/device2025-04: 0 reports for this device; peer average 2/device2026-02: 0 reports for this device; peer average 2/device0103040708100102040611120506081011110304010402
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0102
2019-0303
2019-0402
2019-0702
2019-0804
2019-1011
2020-0111
2020-0211
2020-0411
2020-0602
2020-1122
2020-1222
2021-0511
2021-0601
2021-0811
2021-1002
2021-1104
2023-1102
2024-0302
2024-0402
2025-0101
2025-0402
2026-0202
This device (reports/month)Average device in LMB (reports/device/month)
Failure-mode summaryAI-generated

10 linked report narratives available — no AI summary generated yet.

Recall history

No recalls linked.

Individual MAUDE reports
DateReport #TypeNarrativeLink basis
2021-08-031221934-2021-02365MalfunctionAvailableexact di
2021-05-141221934-2021-01557MalfunctionAvailableexact di
2020-12-041221934-2020-03740MalfunctionAvailableexact di
2020-12-041221934-2020-03743MalfunctionAvailableexact di
2020-11-301221934-2020-03623MalfunctionAvailableexact di
2020-11-301221934-2020-03622MalfunctionAvailableexact di
2020-04-081221934-2020-01096MalfunctionAvailableexact di
2020-02-141221934-2020-00584MalfunctionAvailableexact di
2020-01-161221934-2020-00224MalfunctionAvailableexact di
2019-10-181221934-2019-59094MalfunctionAvailableexact di
Regulatory clearances

None linked.

Manufacturer compliance record
DateTypeOutcomeFacilityCitations
2026-02-13VAIVoluntary action indicatedNDS Surgical Imaging LLC1
2026-02-13VAIVoluntary action indicatedNDS Surgical Imaging LLC1
2015-03-25NAINo action indicatedNDS Surgical Imaging LLC1
2015-03-25NAINo action indicatedNDS Surgical Imaging LLC1
2012-08-17VAIVoluntary action indicatedNDS Surgical Imaging LLC4
2012-08-17VAIVoluntary action indicatedNDS Surgical Imaging LLC4
2012-04-20VAIVoluntary action indicatedNDS Surgical Imaging LLC1
2012-04-20VAIVoluntary action indicatedNDS Surgical Imaging LLC1
2010-07-21VAIVoluntary action indicatedNDS Surgical Imaging LLC1
2010-07-21VAIVoluntary action indicatedNDS Surgical Imaging LLC1
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