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2026 data FDA MAUDE openFDA

Duodenoscope 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 Duodenoscope And Accessories, Flexible/Rigid MID-BOOK · MAUDE

#136 of 1000 · 19,614 reports · 1994–2026

  • BOOK 19,614 reports
  • RANK #136 of 1000
  • DEATH 182 death-typed
  • INJ 2,566 injury-typed
  • MALF 16,802 malfunction
  • SPAN 1994–2026
  • PEAK 2025: 3,985
  • PHOTO Catheter

Nearest event-volume peer: Catheter, Intravascular, Diagnostic (138 report gap)

Duodenoscope And Accessories, Flexible/Rigid sits #136 of 1000 among tracked device types with 19,614 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 →

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 0.9% corpus 1.5% · below corpus mean (-0.6 pp)
  • INJ 13.1% corpus 30.4% · below corpus mean (-17.4 pp)
  • MALF 85.7% corpus 64.5% · above corpus mean (+21.2 pp)

Lead product-problem code Failure to Clean Adequately is 20% of coded problems · Lead manufacturer AIZU OLYMPUS CO., LTD. accounts for 57% of manufacturer-tagged reports · Top event location is 74% of location-tagged rows .

Duodenoscope 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 Duodenoscope And Accessories, Flexible/Rigid carries 19,614 MAUDE reports, ranked #136 of 1000.

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

Event Types

Malfunction 16,802 (85.7%)
Injury 2,566 (13.1%)
Death 182 (0.9%)
40 (0.2%)
Other 24 (0.1%)

Patient Outcomes

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

16,901 (83.9%)
Other 1,208 (6.0%)
Required Intervention 1,015 (5.0%)
R 238 (1.2%)
O 214 (1.1%)
Hospitalization 211 (1.0%)
Death 185 (0.9%)
H 72 (0.4%)
L 27 (0.1%)
D 22 (0.1%)
Disability 21 (0.1%)
Life Threatening 15 (0.1%)
S 6 (0.0%)
Congenital Anomaly 4 (0.0%)

Top Product Problems

Failure to Clean Adequately 3,665
Microbial Contamination of Device 2,030
Loss of or Failure to Bond 1,707
Detachment of Device or Device Component 1,610
Peeled/Delaminated 1,567
Break 1,378
Device Reprocessing Problem 1,078
Crack 1,022
Adverse Event Without Identified Device or Use Problem 863
Contamination 671
Device Contamination with Chemical or Other Material 344
Mechanical Problem 306
Corroded 295
Contamination /Decontamination Problem 285
Material Separation 285
Fluid/Blood Leak 273
Material Split, Cut or Torn 264
Degraded 249
Optical Problem 245
Optical Obstruction 243

Yearly Trend

94
1994: 2
96
1996: 2
97
1997: 6
98
1998: 2
99
1999: 3
02
2002: 1
05
2005: 1
07
2007: 4
08
2008: 11
09
2009: 18
10
2010: 12
11
2011: 10
12
2012: 15
13
2013: 18
14
2014: 36
15
2015: 246
16
2016: 247
17
2017: 791
18
2018: 481
19
2019: 1,347
20
2020: 822
21
2021: 1,270
22
2022: 2,619
23
2023: 3,050
24
2024: 3,019
25
2025: 3,985
26
2026: 1,596

Related Entities for Duodenoscope And Accessories, Flexible/Rigid

Top Manufacturers

AIZU OLYMPUS CO., LTD. 10,469
HOYA CORPORATION PENTAX TOKYO OFFICE 3,797
OLYMPUS MEDICAL SYSTEMS CORP. 3,445
BOSTON SCIENTIFIC CORPORATION 484
UNKNOWN 26

Event Locations

14,551 (74.2%)
I 3,017 (15.4%)
HOSPITAL 1,100 (5.6%)
OTHER 904 (4.6%)
NO INFORMATION 32 (0.2%)
OUTPATIENT TREATMENT FACILITY 3 (0.0%)
HOME 2 (0.0%)
OUTPATIENT DIAGNOSTIC FACILITY 2 (0.0%)
AMBULATORY SURGICAL FACILITY 1 (0.0%)
INVALID DATA 1 (0.0%)
NURSING HOME 1 (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 Duodenoscope 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 (19,614 here).

Catheter, Intravascular, Diagnostic 19,752 System, Image Processing, Radiological 19,390 Orthopedic Stereotaxic Instrument 19,167 Port & Catheter 20,085

Similar death-typed counts

Nearest other device types by death-typed report count (182 here), distinct from the volume row.

Transcatheter Septal Occluder 182 Stent, Superficial Femoral Artery 181 Prosthesis 184 Catheter 179

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

Disclaimer: MAUDE figures for Duodenoscope 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 Duodenoscope 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.