2026 data FDA MAUDE openFDA FDA Class II

Endoscope, Rigid

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, Rigid LIGHT-BOOK · MAUDE

#573 of 1000 · 1,495 reports · 1996–2026

  • BOOK 1,495 reports
  • RANK #573 of 1000
  • DEATH 1 death-typed
  • INJ 11 injury-typed
  • MALF 1,482 malfunction
  • SPAN 1996–2026
  • PEAK 2025: 616
  • PHOTO Instrument

Nearest event-volume peer: Instrument, Cutting, Orthopedic (1 report gap)

Endoscope, Rigid sits #573 of 1000 among tracked device types with 1,495 MAUDE reports spanning 1996–2026. 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, Rigid carries 99.1% MALFUNCTION-coded reports, 34.3pp 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 0.7% corpus 30.3% · below corpus mean (-29.6 pp)
  • MALF 99.1% corpus 64.8% · above corpus mean (+34.3 pp)

Lead product-problem code Poor Quality Image is 41% of coded problems · Lead manufacturer OLYMPUS WINTER & IBE GMBH accounts for 98% of manufacturer-tagged reports · Top event location is 98% of location-tagged rows .

Endoscope, Rigid in the event-volume neighbourhood

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

reports

What this shows Endoscope, Rigid carries 1,495 MAUDE reports, ranked #573 of 1000.

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

Event Types

Malfunction 1,482 (99.1%)
Injury 11 (0.7%)
1 (0.1%)
Death 1 (0.1%)

Patient Outcomes

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

1,454 (98.3%)
Other 14 (0.9%)
Required Intervention 7 (0.5%)
O 2 (0.1%)
Death 1 (0.1%)
Hospitalization 1 (0.1%)

Top Product Problems

Poor Quality Image 700
No Display/Image 187
Break 168
Communication or Transmission Problem 126
Dent in Material 56
Failure to Clean Adequately 46
Scratched Material 45
Erratic or Intermittent Display 43
Optical Problem 43
Material Split, Cut or Torn 41
Output Problem 40
Display or Visual Feedback Problem 38
Image Display Error/Artifact 27
Fracture 26
Loose or Intermittent Connection 26
Sharp Edges 26
Crack 24
Image Orientation Incorrect 22
Leak/Splash 18
Material Integrity Problem 18

Yearly Trend

96
1996: 6
97
1997: 1
09
2009: 2
14
2014: 1
15
2015: 1
16
2016: 6
17
2017: 3
18
2018: 1
19
2019: 5
20
2020: 1
21
2021: 5
22
2022: 4
23
2023: 2
24
2024: 449
25
2025: 616
26
2026: 392

Reports rose to 616 in 2025, up from an average of 226 in the two years before - a recent-year increase, not a lifetime pattern.

Related Entities for Endoscope, Rigid

Event Locations

1,465 (98.0%)
I 12 (0.8%)
HOSPITAL 9 (0.6%)
NOT APPLICABLE 5 (0.3%)
OTHER 2 (0.1%)
NO INFORMATION 1 (0.1%)
OUTPATIENT TREATMENT FACILITY 1 (0.1%)

Compare OLYMPUS WINTER & IBE GMBH vs Olympus Winter & Ibe GmbH →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Endoscope, Rigid: 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 (1,495 here).

Similar death-typed counts

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

Disclaimer: MAUDE figures for Endoscope, Rigid 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, Rigid; 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.