2026 data FDA MAUDE openFDA FDA Class II

Endoscope, Ac-Powered And Accessories

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, Ac-Powered And Accessories LIGHT-BOOK · MAUDE

#779 of 1000 · 697 reports · 1994–2026

  • BOOK 697 reports
  • RANK #779 of 1000
  • DEATH 0 death-typed
  • INJ 117 injury-typed
  • MALF 578 malfunction
  • SPAN 1994–2026
  • PEAK 2025: 182
  • PHOTO Accessories

Nearest event-volume peer: Accessories, Photographic, For Endoscope (Exclude Light Sources) (1 report gap)

Endoscope, Ac-Powered And Accessories sits #779 of 1000 among tracked device types with 697 MAUDE reports spanning 1994–2026. 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, Ac-Powered And Accessories carries 82.9% MALFUNCTION-coded reports, 18.1pp 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 16.8% corpus 30.3% · below corpus mean (-13.5 pp)
  • MALF 82.9% corpus 64.8% · above corpus mean (+18.1 pp)

Lead product-problem code Break is 51% of coded problems · Lead manufacturer OLYMPUS WINTER & IBE GMBH accounts for 99% of manufacturer-tagged reports · Top event location is 67% of location-tagged rows .

Endoscope, Ac-Powered And Accessories in the event-volume neighbourhood

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

reports

What this shows Endoscope, Ac-Powered And Accessories carries 697 MAUDE reports, ranked #779 of 1000.

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

Event Types

Malfunction 578 (82.9%)
Injury 117 (16.8%)
1 (0.1%)
Other 1 (0.1%)

Patient Outcomes

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

580 (82.3%)
Other 58 (8.2%)
Required Intervention 41 (5.8%)
Hospitalization 15 (2.1%)
R 9 (1.3%)
H 1 (0.1%)
Disability 1 (0.1%)

Top Product Problems

Break 381
Detachment of Device or Device Component 66
Detachment Of Device Component 35
Fracture 30
Adverse Event Without Identified Device or Use Problem 26
Mechanical Problem 26
Product Quality Problem 23
Crack 21
Material Twisted/Bent 20
Component Falling 19
Material Fragmentation 18
Contamination 14
Component Missing 10
Difficult to Open or Close 10
Thermal Decomposition of Device 10
Loose or Intermittent Connection 9
Poor Quality Image 9
Material Integrity Problem 8
Material Deformation 7
Unstable 7

Yearly Trend

94
1994: 2
95
1995: 4
97
1997: 2
98
1998: 2
15
2015: 4
16
2016: 13
17
2017: 117
18
2018: 26
19
2019: 19
20
2020: 18
21
2021: 12
22
2022: 26
23
2023: 100
24
2024: 108
25
2025: 182
26
2026: 62

Reports rose to 182 in 2025, up from an average of 104 in the two years before - a recent-year increase, not a lifetime pattern.

Related Entities for Endoscope, Ac-Powered And Accessories

Event Locations

470 (67.4%)
I 195 (28.0%)
HOSPITAL 27 (3.9%)
NO INFORMATION 4 (0.6%)
INVALID DATA 1 (0.1%)

Compare OLYMPUS WINTER & IBE GMBH vs WILSON-COOK MEDICAL, INC. →

Nationwide devices with a comparable report-volume footprint

Endoscope, Ac-Powered And Accessories 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 (697 here).

Similar death-typed counts

Nearest other device types by death-typed report count (0 here), distinct from the volume row.

Disclaimer: MAUDE figures for Endoscope, Ac-Powered And Accessories 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, Ac-Powered And Accessories; 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.