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2026 data FDA MAUDE openFDA FDA Class II

Colonoscope And Accessories, Flexible/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).

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FDA MAUDE casebook

openFDA event book Colonoscope And Accessories, Flexible/Rigid MID-BOOK · MAUDE

#49 of 1000 · 78,298 reports · 1992–2026

  • BOOK 78,298 reports
  • RANK #49 of 1000
  • DEATH 63 death-typed
  • INJ 1,345 injury-typed
  • MALF 76,753 malfunction
  • SPAN 1992–2026
  • PEAK 2026: 23,142
  • PHOTO Aortic Valve

Nearest event-volume peer: Aortic Valve, Prosthesis, Percutaneously Delivered (154 report gap)

Colonoscope And Accessories, Flexible/Rigid sits #49 of 1000 among tracked device types with 78,298 MAUDE reports spanning 1992–2026. 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

Colonoscope And Accessories, Flexible/Rigid carries 98.0% MALFUNCTION-coded reports, 33.2pp 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 1.7% corpus 30.3% · below corpus mean (-28.6 pp)
  • MALF 98.0% corpus 64.8% · above corpus mean (+33.2 pp)

Lead product-problem code Failure to Clean Adequately is 28% of coded problems · Lead manufacturer AIZU OLYMPUS CO., LTD. accounts for 68% of manufacturer-tagged reports · Top event location is 95% of location-tagged rows .

Colonoscope And Accessories, Flexible/Rigid in the event-volume neighbourhood

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

reports

What this shows Colonoscope And Accessories, Flexible/Rigid carries 78,298 MAUDE reports, ranked #49 of 1000.

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

Event Types

Malfunction 76,753 (98.0%)
Injury 1,345 (1.7%)
Other 117 (0.1%)
Death 63 (0.1%)
20 (0.0%)

Patient Outcomes

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

76,489 (97.8%)
Other 629 (0.8%)
Required Intervention 435 (0.6%)
Hospitalization 214 (0.3%)
R 189 (0.2%)
O 77 (0.1%)
Death 58 (0.1%)
H 49 (0.1%)
L 21 (0.0%)
Life Threatening 18 (0.0%)
Disability 13 (0.0%)
S 9 (0.0%)
Congenital Anomaly 9 (0.0%)
D 6 (0.0%)
C 1 (0.0%)

Top Product Problems

Failure to Clean Adequately 22,063
No Display/Image 8,012
Communication or Transmission Problem 7,661
Device Reprocessing Problem 4,958
Microbial Contamination of Device 4,915
Break 4,865
Poor Quality Image 4,602
Erratic or Intermittent Display 4,509
Optical Obstruction 2,594
Obstruction of Flow 2,497
Fluid/Blood Leak 2,312
Residue After Decontamination 2,257
Detachment of Device or Device Component 1,687
Corroded 1,196
Contamination 1,115
Optical Distortion 767
Display or Visual Feedback Problem 542
Adverse Event Without Identified Device or Use Problem 536
Contamination /Decontamination Problem 534
Unintended Movement 475

Yearly Trend

92
1992: 14
93
1993: 5
94
1994: 10
95
1995: 6
96
1996: 18
97
1997: 31
98
1998: 23
99
1999: 18
00
2000: 31
01
2001: 37
02
2002: 50
03
2003: 39
04
2004: 20
05
2005: 41
06
2006: 37
07
2007: 81
08
2008: 68
09
2009: 83
10
2010: 48
11
2011: 77
12
2012: 88
13
2013: 63
14
2014: 60
15
2015: 100
16
2016: 170
17
2017: 370
18
2018: 388
19
2019: 417
20
2020: 687
21
2021: 2,444
22
2022: 8,345
23
2023: 11,748
24
2024: 12,128
25
2025: 17,411
26
2026: 23,142

Reports rose to 17,411 in 2025, up from an average of 11,938 in the two years before - a recent-year increase, not a lifetime pattern.

Related Entities for Colonoscope And Accessories, Flexible/Rigid

Top Manufacturers

AIZU OLYMPUS CO., LTD. 52,512
HOYA CORPORATION PENTAX TOKYO OFFICE 19,688
OLYMPUS MEDICAL SYSTEMS CORP. 3,530
SHIRAKAWA OLYMPUS CO., LTD. 836
BOSTON SCIENTIFIC CORPORATION 138

Event Locations

74,515 (95.2%)
I 3,191 (4.1%)
HOSPITAL 429 (0.5%)
NO INFORMATION 62 (0.1%)
AMBULATORY SURGICAL FACILITY 42 (0.1%)
OTHER 17 (0.0%)
OUTPATIENT DIAGNOSTIC FACILITY 17 (0.0%)
INVALID DATA 11 (0.0%)
OUTPATIENT TREATMENT FACILITY 9 (0.0%)
UNKNOWN 4 (0.0%)
HOME 1 (0.0%)

Compare AIZU OLYMPUS CO., LTD. vs HOYA CORPORATION PENTAX TOKYO OFFICE →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Colonoscope And Accessories, Flexible/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 (78,298 here).

Aortic Valve 78,144 Analyzer, Chemistry, For Clinical Use 78,872 Intraocular Lens 79,358 Orthopedic Manual Surgical Instrument 81,214

Similar death-typed counts

Nearest other device types by death-typed report count (63 here), distinct from the volume row.

Dressing, Wound, Drug 63 Electrode, Pacemaker, Temporary 65 Pancreatic Stent 65 Occluder, Patent Ductus, Arteriosus 60

Read our methodology - how this data is sourced, computed, and verified.

Disclaimer: MAUDE figures for Colonoscope And Accessories, Flexible/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 Colonoscope And Accessories, Flexible/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.