Endoscope, Accessories, Image Post-Processing For Color Enhancement
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 Endoscope LIGHT-BOOK · MAUDE
#821 of 1000 · 608 reports · 2015–2026
- BOOK 608 reports
- RANK #821 of 1000
- DEATH 0 death-typed
- INJ 10 injury-typed
- MALF 598 malfunction
- SPAN 2015–2026
- PEAK 2021: 201
- PHOTO Cutter, Surgical
Nearest event-volume peer: Cutter, Surgical (1 report gap)
Endoscope, Accessories, Image Post-Processing For Color Enhancement sits #821 of 1000 among tracked device types with 608 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
Endoscope carries 98.4% MALFUNCTION-coded reports, 33.5pp 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 1.6% corpus 30.3% · below corpus mean (-28.6 pp)
- MALF 98.4% corpus 64.8% · above corpus mean (+33.5 pp)
Lead product-problem code No Display/Image is 23% of coded problems · Lead manufacturer HOYA CORPORATION PENTAX TOKYO OFFICE accounts for 89% of manufacturer-tagged reports · Top event location is 68% of location-tagged rows .
Endoscope in the event-volume neighbourhood
FDA MAUDE report totals among this device type and nearest nationwide peers
- Endoscope (this)
Endoscope, Accessories, Image Post-Processing For Color Enhancement
608 reports
- Cutter
Cutter, Surgical
607 reports
- Unit
Unit, Liquid-Oxygen, Portable
607 reports
- Source
Source, Brachytherapy, Radionuclide
606 reports
- Probe
Probe
602 reports
- Table
Table, Obstetric (And Accessories)
602 reports
What this shows Endoscope, Accessories, Image Post-Processing For Color Enhancement carries 608 MAUDE reports, ranked #821 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 (61) held close to the prior two-year average of 91.
Related Entities for Endoscope, Accessories, Image Post-Processing For Color Enhancement
Top Manufacturers
Event Locations
Compare HOYA CORPORATION PENTAX TOKYO OFFICE vs BOSTON SCIENTIFIC CORPORATION →
Nationwide devices with a comparable report-volume footprint
Endoscope carries zero death-typed MAUDE reports, so the peer set below compares report volume only; both axes are floored at ≥100 reports so the neighborhood stays in the advertised mass.
Similar report volume
Nearest other device types by FDA MAUDE report count (608 here).
Similar death-typed counts
Nearest other device types by death-typed report count (0 here), distinct from the volume row.
Read our methodology - how this data is sourced, computed, and verified.
Disclaimer: MAUDE figures for Endoscope 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 Endoscope; 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.