Confocal Optical Imaging
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 Confocal Optical Imaging LIGHT-BOOK · MAUDE
#564 of 1000 · 1,525 reports · 2015–2026
- BOOK 1,525 reports
- RANK #564 of 1000
- DEATH 1 death-typed
- INJ 80 injury-typed
- MALF 1,443 malfunction
- SPAN 2015–2026
- PEAK 2022: 346
- PHOTO Laser, Ophthalmic
Nearest event-volume peer: Laser, Ophthalmic (0 report gap)
Confocal Optical Imaging sits #564 of 1000 among tracked device types with 1,525 MAUDE reports spanning 2015–2026. 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
Confocal Optical Imaging carries 94.6% MALFUNCTION-coded reports, 29.8pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.
- DEATH 0.1% corpus 1.5% · below corpus mean (-1.4 pp)
- INJ 5.2% corpus 30.3% · below corpus mean (-25.0 pp)
- MALF 94.6% corpus 64.8% · above corpus mean (+29.8 pp)
Lead product-problem code No Display/Image is 23% of coded problems · Lead manufacturer STRYKER ENDOSCOPY-SAN JOSE accounts for 46% of manufacturer-tagged reports · Top event location is 71% of location-tagged rows .
Confocal Optical Imaging in the event-volume neighbourhood
FDA MAUDE report totals among this device type and nearest nationwide peers
- Confocal Opti… (this)
Confocal Optical Imaging
1,525 reports
- Laser
Laser, Ophthalmic
1,525 reports
- Screw
Screw, Fixation, Intraosseous
1,522 reports
- Mesh
Mesh, Surgical, For Stress Urinary Incontinence, Male
1,516 reports
- Continuous Gl…
Continuous Glucose Monitor, Implanted, Adjunctive Use
1,514 reports
- Nad Reduction…
Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes
1,513 reports
What this shows Confocal Optical Imaging carries 1,525 MAUDE reports, ranked #564 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 (197) held close to the prior two-year average of 165.
Related Entities for Confocal Optical Imaging
Top Manufacturers
Event Locations
Compare STRYKER ENDOSCOPY-SAN JOSE vs OLYMPUS MEDICAL SYSTEMS CORP. →
Nationwide devices with a comparable volume-and-death footprint
Two openFDA-derived peer sets for Confocal Optical Imaging: 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 (1,525 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 Confocal Optical Imaging 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 Confocal Optical Imaging; 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.