PlainHospital
2026 data FDA MAUDE openFDA

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.

Browse devices → Device safety hub

FDA MAUDE casebook

openFDA event book Confocal Optical Imaging LIGHT-BOOK · MAUDE

#572 of 1000 · 1,409 reports · 2015–2026

  • BOOK 1,409 reports
  • RANK #572 of 1000
  • DEATH 1 death-typed
  • INJ 76 injury-typed
  • MALF 1,331 malfunction
  • SPAN 2015–2026
  • PEAK 2022: 346
  • PHOTO Prosthesis

Nearest event-volume peer: Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive (1 report gap)

Confocal Optical Imaging sits #572 of 1000 among tracked device types with 1,409 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 →

Event-type mix vs corpus

Shares of FDA event_type codes on this device type, compared with the mean across 1,000 device types that have ≥100 MAUDE reports. Codes are report labels, not adjudicated causation.

  • DEATH 0.1% corpus 1.5% · below corpus mean (-1.4 pp)
  • INJ 5.4% corpus 30.4% · below corpus mean (-25.0 pp)
  • MALF 94.5% corpus 64.5% · above corpus mean (+30.0 pp)

Lead product-problem code No Display/Image is 24% of coded problems · Lead manufacturer STRYKER ENDOSCOPY-SAN JOSE accounts for 48% of manufacturer-tagged reports · Top event location is 68% of location-tagged rows .

Confocal Optical Imaging in the event-volume neighbourhood

FDA MAUDE report totals among this device type and nearest nationwide peers

reports

What this shows Confocal Optical Imaging carries 1,409 MAUDE reports, ranked #572 of 1000.

Source FDA MAUDE via openFDA, aggregated by PlainHospital As of August 2026

Event Types

Malfunction 1,331 (94.5%)
Injury 76 (5.4%)
Death 1 (0.1%)
Other 1 (0.1%)

Patient Outcomes

FDA patient-outcome codes (separate from event_type). Percentages use this chart's row total.

1,316 (93.5%)
Other 76 (5.4%)
Required Intervention 5 (0.4%)
O 2 (0.1%)
Disability 2 (0.1%)
Hospitalization 2 (0.1%)
H 1 (0.1%)
R 1 (0.1%)
Death 1 (0.1%)
Life Threatening 1 (0.1%)

Top Product Problems

No Display/Image 375
Output Problem 286
Communication or Transmission Problem 120
Temperature Problem 119
Poor Quality Image 118
Optical Problem 112
Electrical /Electronic Property Problem 82
Failure to Power Up 46
Overheating of Device 40
Display or Visual Feedback Problem 38
Adverse Event Without Identified Device or Use Problem 37
Erratic or Intermittent Display 37
Thermal Decomposition of Device 28
Energy Output Problem 22
Break 21
Insufficient Information 20
Fogging 19
No Device Output 17
Electrical Power Problem 15
Excessive Heating 15

Yearly Trend

15
2015: 1
16
2016: 4
17
2017: 12
18
2018: 11
19
2019: 59
20
2020: 105
21
2021: 312
22
2022: 346
23
2023: 164
24
2024: 165
25
2025: 197
26
2026: 33

Related Entities for Confocal Optical Imaging

Top Manufacturers

STRYKER ENDOSCOPY-SAN JOSE 630
OLYMPUS MEDICAL SYSTEMS CORP. 472
KARL STORZ SE & CO. KG 129
SHIRAKAWA OLYMPUS CO., LTD. 92

Event Locations

962 (68.3%)
I 415 (29.5%)
HOSPITAL 27 (1.9%)
NO INFORMATION 4 (0.3%)
AMBULATORY SURGICAL FACILITY 1 (0.1%)

Compare STRYKER ENDOSCOPY-SAN JOSE vs OLYMPUS MEDICAL SYSTEMS CORP. →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Confocal Optical Imaging, both floored at ≥100 reports so the neighborhoods stay in the advertised mass.

Similar report volume

Nearest other device types by FDA MAUDE report count (1,409 here).

Prosthesis 1,410 Washer, Bolt Nut 1,404 External Mandibular Fixator And/Or Distract… 1,403 Lens, Intraocular, Accommodative 1,402

Similar death-typed counts

Nearest other device types by death-typed report count (1 here), distinct from the volume row.

Abutment, Implant, Dental, Endosseous 1 Active Implantable Bone Conduction Hearing… 1 Aid, Surgical, Viscoelastic 1 Alarm, Conditioned Response Enuresis 1

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.