Powered Laser Surgical Instrument
Adverse-event figures are drawn from the U.S. Food & Drug Administration (FDA) MAUDE database, refreshed March 2026, see our methodology.
OpenFDA device adverse-event casebook.
FDA Class II (moderate risk, special controls required), regulated under 21 CFR §878.4810 (General, Plastic Surgery panel).
FDA MAUDE casebook
openFDA event book Powered Laser Surgical Instrument MID-BOOK · MAUDE
#77 of 1000 · 44,086 reports · 1992–2026
- BOOK 44,086 reports
- RANK #77 of 1000
- DEATH 107 death-typed
- INJ 8,812 injury-typed
- MALF 34,415 malfunction
- SPAN 1992–2026
- PEAK 2018: 3,525
- PHOTO Stimulator
Nearest event-volume peer: Stimulator, Spinal-Cord, Implanted (Pain Relief) (154 report gap)
Powered Laser Surgical Instrument sits #77 of 1000 among tracked device types with 44,086 MAUDE reports spanning 1992–2026. Rank counts report volume, not confirmed device fault. Event_type Death / Injury / Malfunction are one code per report — not the same population as patient-outcome rows ( methodology). Read with this device → · Lead manufacturer → · Similar-volume device →
Malfunction reports run above the device-type norm
Powered Laser Surgical Instrument carries 78.1% MALFUNCTION-coded reports, 13.2pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.
- DEATH 0.2% corpus 1.5% · below corpus mean (-1.3 pp)
- INJ 20.0% corpus 30.3% · below corpus mean (-10.3 pp)
- MALF 78.1% corpus 64.8% · above corpus mean (+13.2 pp)
Lead product-problem code Break is 20% of coded problems · Lead manufacturer AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE) accounts for 31% of manufacturer-tagged reports · Top event location is 56% of location-tagged rows .
Powered Laser Surgical Instrument in the event-volume neighbourhood
FDA MAUDE report totals among this device type and nearest nationwide peers
- Temporary Non…
Temporary Non-Roller Type Left Heart Support Blood Pump
44,306 reports
- Powered Laser… (this)
Powered Laser Surgical Instrument
44,086 reports
- Stimulator
Stimulator, Spinal-Cord, Implanted (Pain Relief)
43,932 reports
- Dialyzer
Dialyzer, High Permeability With Or Without Sealed Dialysate System
43,552 reports
- Catheters
Catheters, Transluminal Coronary Angioplasty, Percutaneous
43,512 reports
- Neurological…
Neurological Stereotaxic Instrument
42,726 reports
What this shows Powered Laser Surgical Instrument carries 44,086 MAUDE reports, ranked #77 of 1000.
Event Types
Patient Outcomes
FDA patient-outcome codes (separate from event_type). Percentages use this chart's row total.
Top Product Problems
Yearly Trend
Reports in 2025 (2,831) held close to the prior two-year average of 2,294.
Related Entities for Powered Laser Surgical Instrument
Top Manufacturers
Event Locations
Compare AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE) vs BOSTON SCIENTIFIC CORPORATION →
Nationwide devices with a comparable volume-and-death footprint
Two openFDA-derived peer sets for Powered Laser Surgical Instrument: nearest by total report volume and nearest by death-typed count, each floored at ≥100 reports so the neighborhoods stay in the advertised mass.
Similar report volume
Nearest other device types by FDA MAUDE report count (44,086 here).
Similar death-typed counts
Nearest other device types by death-typed report count (107 here), distinct from the volume row.
Read our methodology - how this data is sourced, computed, and verified.
Disclaimer: MAUDE figures for Powered Laser Surgical Instrument are informational only and are not clinical advice. Report codes do not prove device causation. Consult a qualified clinician before acting on this data.
Every figure on PlainHospital is rendered directly from federal source data, no number is typed in by an editor. Event-type mix on this page is computed from FDA MAUDE codes for Powered Laser Surgical Instrument; corpus means use device types with ≥100 reports. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of August 2026.