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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.

1 linked reportInjury 1
12342019-06: 0 reports for this device; peer average 3/device2019-07: 1 reports for this device; peer average 1/device2022-05: 0 reports for this device; peer average 1/device2023-02: 0 reports for this device; peer average 2.5/device2023-04: 0 reports for this device; peer average 3/device2023-06: 0 reports for this device; peer average 3/device2023-07: 0 reports for this device; peer average 3/device2023-10: 0 reports for this device; peer average 2/device2024-02: 0 reports for this device; peer average 4/device2024-05: 0 reports for this device; peer average 3/device2024-12: 0 reports for this device; peer average 2/device2026-04: 0 reports for this device; peer average 1/device2026-06: 0 reports for this device; peer average 1/device06070502040607100205120406
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0603
2019-0711
2022-0501
2023-0202.5
2023-0403
2023-0603
2023-0703
2023-1002
2024-0204
2024-0503
2024-1202
2026-0401
2026-0601
This device (reports/month)Average device in KWD (reports/device/month)
Failure-mode summaryAI-generated

1 linked report narrative available — no AI summary generated yet.

Recall history

No recalls linked.

Individual MAUDE reports
DateReport #TypeNarrativeLink basis
2019-07-023007420745-2019-00035InjuryAvailablemodel number
Regulatory clearances

None linked.

Manufacturer compliance record
DateTypeOutcomeFacilityCitations
2019-12-11VAIVoluntary action indicatedTrilliant Surgical, LLC5
2019-12-11VAIVoluntary action indicatedTrilliant Surgical, LLC5
2018-05-02VAIVoluntary action indicatedTrilliant Surgical, LLC10
2018-05-02VAIVoluntary action indicatedTrilliant Surgical, LLC10
2016-06-27OAIOfficial action indicatedTrilliant Surgical, LLC9
2016-06-27OAIOfficial action indicatedTrilliant Surgical, LLC9
2015-02-12OAIOfficial action indicatedTrilliant Surgical, LLC5
2015-02-12OAIOfficial action indicatedTrilliant Surgical, LLC5
2011-09-09VAIVoluntary action indicatedTrilliant Surgical, LLC3
2011-09-09VAIVoluntary action indicatedTrilliant Surgical, LLC3
2010-05-03WLWarning LetterTrilliant Surgical, LLC—
2010-05-03WLWarning LetterTrilliant Surgical, LLC—
2010-01-20OAIOfficial action indicatedTrilliant Surgical, LLC4
2010-01-20OAIOfficial action indicatedTrilliant Surgical, LLC4
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