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2026 data FDA MAUDE openFDA FDA Class II

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.

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

#127 of 1000 · 24,101 reports · 1994–2026

  • BOOK 24,101 reports
  • RANK #127 of 1000
  • DEATH 186 death-typed
  • INJ 2,644 injury-typed
  • MALF 21,206 malfunction
  • SPAN 1994–2026
  • PEAK 2026: 6,083
  • PHOTO Programmer, Pacemaker

Nearest event-volume peer: Programmer, Pacemaker (58 report gap)

Duodenoscope And Accessories, Flexible/Rigid sits #127 of 1000 among tracked device types with 24,101 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

Duodenoscope And Accessories, Flexible/Rigid carries 88.0% MALFUNCTION-coded reports, 23.2pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.8% corpus 1.5% · below corpus mean (-0.7 pp)
  • INJ 11.0% corpus 30.3% · below corpus mean (-19.3 pp)
  • MALF 88.0% corpus 64.8% · above corpus mean (+23.2 pp)

Lead product-problem code Failure to Clean Adequately is 17% of coded problems · Lead manufacturer AIZU OLYMPUS CO., LTD. accounts for 66% of manufacturer-tagged reports · Top event location is 79% 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 24,101 MAUDE reports, ranked #127 of 1000.

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

Event Types

Malfunction 21,206 (88.0%)
Injury 2,644 (11.0%)
Death 186 (0.8%)
40 (0.2%)
Other 25 (0.1%)

Patient Outcomes

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

21,269 (86.5%)
Other 1,217 (5.0%)
Required Intervention 1,061 (4.3%)
R 244 (1.0%)
O 214 (0.9%)
Hospitalization 214 (0.9%)
Death 188 (0.8%)
H 77 (0.3%)
L 27 (0.1%)
D 23 (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 4,116
Microbial Contamination of Device 2,197
Crack 2,154
Peeled/Delaminated 2,153
Detachment of Device or Device Component 2,135
Loss of or Failure to Bond 1,754
Device Reprocessing Problem 1,575
Break 1,540
Adverse Event Without Identified Device or Use Problem 963
Degraded 756
Contamination 737
Corroded 576
Residue After Decontamination 505
Material Fragmentation 406
Material Separation 395
Material Split, Cut or Torn 351
Device Contamination with Chemical or Other Material 350
Mechanical Problem 309
Material Discolored 306
Contamination /Decontamination Problem 304

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: 6,083

Reports in 2025 (3,985) held close to the prior two-year average of 3,035.

Related Entities for Duodenoscope And Accessories, Flexible/Rigid

Top Manufacturers

AIZU OLYMPUS CO., LTD. 14,846
HOYA CORPORATION PENTAX TOKYO OFFICE 3,825
OLYMPUS MEDICAL SYSTEMS CORP. 3,446
BOSTON SCIENTIFIC CORPORATION 509
UNKNOWN 26

Event Locations

19,025 (78.9%)
I 3,017 (12.5%)
HOSPITAL 1,113 (4.6%)
OTHER 904 (3.8%)
NO INFORMATION 32 (0.1%)
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 a comparable volume-and-death footprint

Two openFDA-derived peer sets for Duodenoscope 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 (24,101 here).

Programmer, Pacemaker 24,159 Instrument, Biopsy 23,840 Thoracolumbosacral Pedicle Screw System 24,647 Counter, Differential Cell 23,439

Similar death-typed counts

Nearest other device types by death-typed report count (186 here), distinct from the volume row.

Dilator 185 Stent, Superficial Femoral Artery 185 Wheelchair, Powered 188 Catheter 181

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.