AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE)
Manufacturer adverse-event records for AMERICAN MEDICAL SYSTEMS, INC. come from the U.S. Food & Drug Administration (FDA) MAUDE database via openFDA, refreshed March 2026 - see our methodology. Not medical advice.
FDA MAUDE device safety record · 2014–2019 · thin-book · quiet Death-code · balanced
Death-code intensity
AMERICAN MEDICAL SYSTEMS, INC. is quieter on Death-coded events
Death-coded event_type rows are 1 of 5,948 (0.02% · quiet tercile among 434 manufacturers). Absolute volume is thin-book.
What the Death-code reading shows for AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE)
The standout signal for AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE) is Death-code intensity: 0.02% of 5,948 reports (quiet tercile), while absolute volume is thin-book.
As a thinner-book manufacturer, a handful of device families can swing the totals; open the device table rather than reading the company headline alone. Event_type counts are not the same population as Patient Outcomes.
Reports span 1 device type, led in this extract by Malfunction at 5,266 (88.5% of event_type total). Peak single-year volume reaches 1,270 reports across 6 years. These are raw FDA submissions, not adjudicated findings. Snapshot . Verify current communications on the FDA MDR page.
Event Types
Patient Outcomes
FDA patient-outcome codes (separate from event_type). Percentages use this chart's row total.
Devices (1)
| Device | Reports |
|---|---|
| Powered Laser Surgical Instrument | 5,948 |
Yearly Trend
Read our methodology - how this data is sourced, computed, and verified.