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2026 data FDA MAUDE openFDA

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.

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FDA MAUDE casebook

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

#58 of 1000 · 62,094 reports · 1992–2026

  • BOOK 62,094 reports
  • RANK #58 of 1000
  • DEATH 63 death-typed
  • INJ 1,311 injury-typed
  • MALF 60,583 malfunction
  • SPAN 1992–2026
  • PEAK 2025: 17,411
  • PHOTO System

Nearest event-volume peer: System, Balloon, Intra-Aortic And Control (2,325 report gap)

Colonoscope And Accessories, Flexible/Rigid sits #58 of 1000 among tracked device types with 62,094 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 →

Event-type mix vs corpus

Shares of FDA event_type codes on this device type, compared with the mean across 1,000 device types that have ≥100 MAUDE reports. Codes are report labels, not adjudicated causation.

  • DEATH 0.1% corpus 1.5% · below corpus mean (-1.4 pp)
  • INJ 2.1% corpus 30.4% · below corpus mean (-28.3 pp)
  • MALF 97.6% corpus 64.5% · above corpus mean (+33.1 pp)

Lead product-problem code Failure to Clean Adequately is 27% of coded problems · Lead manufacturer AIZU OLYMPUS CO., LTD. accounts for 61% of manufacturer-tagged reports · Top event location is 94% 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 62,094 MAUDE reports, ranked #58 of 1000.

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

Event Types

Malfunction 60,583 (97.6%)
Injury 1,311 (2.1%)
Other 117 (0.2%)
Death 63 (0.1%)
20 (0.0%)

Patient Outcomes

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

60,440 (97.3%)
Other 625 (1.0%)
Required Intervention 413 (0.7%)
Hospitalization 211 (0.3%)
R 186 (0.3%)
O 77 (0.1%)
Death 58 (0.1%)
H 44 (0.1%)
L 20 (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 16,209
No Display/Image 5,687
Communication or Transmission Problem 5,097
Break 4,786
Device Reprocessing Problem 4,362
Microbial Contamination of Device 4,300
Erratic or Intermittent Display 3,572
Optical Obstruction 2,487
Poor Quality Image 2,467
Obstruction of Flow 2,437
Fluid/Blood Leak 2,213
Detachment of Device or Device Component 1,587
Residue After Decontamination 1,405
Contamination 1,021
Optical Distortion 764
Corroded 511
Display or Visual Feedback Problem 485
Contamination /Decontamination Problem 482
Unintended Movement 471
Adverse Event Without Identified Device or Use Problem 462

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: 6,938

Related Entities for Colonoscope And Accessories, Flexible/Rigid

Top Manufacturers

AIZU OLYMPUS CO., LTD. 36,849
HOYA CORPORATION PENTAX TOKYO OFFICE 19,237
OLYMPUS MEDICAL SYSTEMS CORP. 3,527
SHIRAKAWA OLYMPUS CO., LTD. 788
BOSTON SCIENTIFIC CORPORATION 133

Event Locations

58,322 (93.9%)
I 3,191 (5.1%)
HOSPITAL 420 (0.7%)
NO INFORMATION 62 (0.1%)
AMBULATORY SURGICAL FACILITY 41 (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%)

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

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Colonoscope And Accessories, Flexible/Rigid, both floored at ≥100 reports so the neighborhoods stay in the advertised mass.

Similar report volume

Nearest other device types by FDA MAUDE report count (62,094 here).

System, Balloon, Intra-Aortic And Control 64,419 Instrument, Ultrasonic Surgical 66,379 Implantable Pacemaker Pulse-Generator 57,343 Screw, Fixation, Bone 56,966

Similar death-typed counts

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

Pancreatic Stent 64 Dressing, Wound, Drug 61 Drug-Eluting Percutaneous Transluminal Coro… 61 Electrode, Pacemaker, Temporary 65

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.