2026 data FDA MAUDE openFDA FDA Class II

Endoscope, Accessories, Narrow Band Spectrum

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, Accessories, Narrow Band Spectrum MID-BOOK · MAUDE

#181 of 1000 · 13,919 reports · 2006–2026

  • BOOK 13,919 reports
  • RANK #181 of 1000
  • DEATH 2 death-typed
  • INJ 173 injury-typed
  • MALF 13,730 malfunction
  • SPAN 2006–2026
  • PEAK 2025: 2,889
  • PHOTO Oximeter

Nearest event-volume peer: Oximeter (100 report gap)

Endoscope, Accessories, Narrow Band Spectrum sits #181 of 1000 among tracked device types with 13,919 MAUDE reports spanning 2006–2026. 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, Accessories, Narrow Band Spectrum carries 98.6% MALFUNCTION-coded reports, 33.8pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.0% corpus 1.5% · below corpus mean (-1.5 pp)
  • INJ 1.2% corpus 30.3% · below corpus mean (-29.0 pp)
  • MALF 98.6% corpus 64.8% · above corpus mean (+33.8 pp)

Lead product-problem code Communication or Transmission Problem is 27% of coded problems · Lead manufacturer SHIRAKAWA OLYMPUS CO., LTD. accounts for 67% of manufacturer-tagged reports · Top event location is 86% of location-tagged rows .

Endoscope, Accessories, Narrow Band Spectrum in the event-volume neighbourhood

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

reports

What this shows Endoscope, Accessories, Narrow Band Spectrum carries 13,919 MAUDE reports, ranked #181 of 1000.

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

Event Types

Malfunction 13,730 (98.6%)
Injury 173 (1.2%)
Other 13 (0.1%)
Death 2 (0.0%)
1 (0.0%)

Patient Outcomes

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

13,591 (98.4%)
Other 118 (0.9%)
Required Intervention 44 (0.3%)
Hospitalization 21 (0.2%)
R 19 (0.1%)
O 8 (0.1%)
H 5 (0.0%)
Death 2 (0.0%)
L 1 (0.0%)
S 1 (0.0%)
Congenital Anomaly 1 (0.0%)
Disability 1 (0.0%)

Top Product Problems

Communication or Transmission Problem 3,545
No Display/Image 1,455
Electrical /Electronic Property Problem 1,151
Poor Quality Image 1,134
Output Problem 1,001
Failure to Power Up 668
No Device Output 618
Break 506
Display or Visual Feedback Problem 452
No Visual Prompts/Feedback 404
Activation Failure 349
Connection Problem 316
Erratic or Intermittent Display 301
Power Problem 271
Optical Problem 237
Defective Component 183
Leak/Splash 178
Key or Button Unresponsive/not Working 174
Image Display Error/Artifact 148
Loose or Intermittent Connection 139

Yearly Trend

06
2006: 2
07
2007: 2
08
2008: 3
09
2009: 1
10
2010: 2
11
2011: 1
12
2012: 1
13
2013: 9
14
2014: 22
15
2015: 32
16
2016: 25
17
2017: 17
18
2018: 4
19
2019: 3
20
2020: 823
21
2021: 1,453
22
2022: 1,828
23
2023: 2,180
24
2024: 2,649
25
2025: 2,889
26
2026: 1,973

Reports in 2025 (2,889) held close to the prior two-year average of 2,415.

Related Entities for Endoscope, Accessories, Narrow Band Spectrum

Event Locations

11,977 (86.0%)
I 1,872 (13.4%)
HOSPITAL 52 (0.4%)
NO INFORMATION 11 (0.1%)
AMBULATORY SURGICAL FACILITY 5 (0.0%)
NOT APPLICABLE 1 (0.0%)
OUTPATIENT TREATMENT FACILITY 1 (0.0%)

Compare SHIRAKAWA OLYMPUS CO., LTD. vs OLYMPUS MEDICAL SYSTEMS CORP. →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Endoscope, Accessories, Narrow Band Spectrum: 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 (13,919 here).

Similar death-typed counts

Nearest other device types by death-typed report count (2 here), distinct from the volume row.

Disclaimer: MAUDE figures for Endoscope, Accessories, Narrow Band Spectrum 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, Accessories, Narrow Band Spectrum; 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.