Light Source, Fiberoptic, Routine
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 §876.1500 (Gastroenterology, Urology panel).
FDA MAUDE casebook
openFDA event book Light Source, Fiberoptic, Routine LIGHT-BOOK · MAUDE
#412 of 1000 · 2,959 reports · 1995–2026
- BOOK 2,959 reports
- RANK #412 of 1000
- DEATH 1 death-typed
- INJ 150 injury-typed
- MALF 2,787 malfunction
- SPAN 1995–2026
- PEAK 2010: 713
- PHOTO System
Nearest event-volume peer: System, Photopheresis, Extracorporeal (7 report gap)
Light Source, Fiberoptic, Routine sits #412 of 1000 among tracked device types with 2,959 MAUDE reports spanning 1995–2026. 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
Light Source, Fiberoptic, Routine carries 94.2% MALFUNCTION-coded reports, 29.4pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.
- DEATH 0.0% corpus 1.5% · below corpus mean (-1.5 pp)
- INJ 5.1% corpus 30.3% · below corpus mean (-25.2 pp)
- MALF 94.2% corpus 64.8% · above corpus mean (+29.4 pp)
Lead product-problem code Device Displays Incorrect Message is 25% of coded problems · Lead manufacturer STRYKER ENDOSCOPY SAN JOSE accounts for 74% of manufacturer-tagged reports · Top event location is 79% of location-tagged rows .
Light Source, Fiberoptic, Routine in the event-volume neighbourhood
FDA MAUDE report totals among this device type and nearest nationwide peers
- Medical Devic…
Medical Device Data System
2,981 reports
- System
System, Photopheresis, Extracorporeal
2,966 reports
- Light Source (this)
Light Source, Fiberoptic, Routine
2,959 reports
- Assay
Assay, Glycosylated Hemoglobin
2,943 reports
- Syringe
Syringe, Antistick
2,941 reports
- Spinal Verteb…
Spinal Vertebral Body Replacement Device
2,930 reports
What this shows Light Source, Fiberoptic, Routine carries 2,959 MAUDE reports, ranked #412 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 (141) held close to the prior two-year average of 179.
Related Entities for Light Source, Fiberoptic, Routine
Top Manufacturers
Event Locations
Compare STRYKER ENDOSCOPY SAN JOSE vs STRYKER ENDOSCOPY-SAN JOSE →
Nationwide devices with a comparable volume-and-death footprint
Two openFDA-derived peer sets for Light Source, Fiberoptic, Routine: 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 (2,959 here).
Similar death-typed counts
Nearest other device types by death-typed report count (1 here), distinct from the volume row.
Read our methodology - how this data is sourced, computed, and verified.
Disclaimer: MAUDE figures for Light Source, Fiberoptic, Routine 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 Light Source, Fiberoptic, Routine; 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.