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2026 data FDA MAUDE openFDA FDA Class II

Accessories, Cleaning, For Endoscope

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 Accessories, Cleaning, For Endoscope LIGHT-BOOK · MAUDE

#318 of 1000 · 5,046 reports · 1992–2026

  • BOOK 5,046 reports
  • RANK #318 of 1000
  • DEATH 22 death-typed
  • INJ 402 injury-typed
  • MALF 4,407 malfunction
  • SPAN 1992–2026
  • PEAK 2023: 998
  • PHOTO Monitor

Nearest event-volume peer: Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass (12 report gap)

Accessories, Cleaning, For Endoscope sits #318 of 1000 among tracked device types with 5,046 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

Accessories, Cleaning, For Endoscope carries 87.3% MALFUNCTION-coded reports, 22.5pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.4% corpus 1.5% · below corpus mean (-1.1 pp)
  • INJ 8.0% corpus 30.3% · below corpus mean (-22.3 pp)
  • MALF 87.3% corpus 64.8% · above corpus mean (+22.5 pp)

Lead product-problem code Device Reprocessing Problem is 25% of coded problems · Lead manufacturer AIZU OLYMPUS CO., LTD. accounts for 66% of manufacturer-tagged reports · Top event location is 71% of location-tagged rows .

Accessories, Cleaning, For Endoscope in the event-volume neighbourhood

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

reports

What this shows Accessories, Cleaning, For Endoscope carries 5,046 MAUDE reports, ranked #318 of 1000.

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

Event Types

Malfunction 4,407 (87.3%)
Injury 402 (8.0%)
151 (3.0%)
Other 64 (1.3%)
Death 22 (0.4%)

Patient Outcomes

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

4,525 (90.0%)
Other 389 (7.7%)
Hospitalization 40 (0.8%)
Required Intervention 37 (0.7%)
Death 21 (0.4%)
R 8 (0.2%)
O 6 (0.1%)
S 1 (0.0%)
Disability 1 (0.0%)
Life Threatening 1 (0.0%)

Top Product Problems

Device Reprocessing Problem 1,091
Break 957
Connection Problem 330
Crack 255
Improper or Incorrect Procedure or Method 216
Detachment of Device or Device Component 186
Adverse Event Without Identified Device or Use Problem 140
Failure to Clean Adequately 137
Leak/Splash 136
Use of Device Problem 132
Other (for use when an appropriate device code cannot be identified) 122
Microbial Contamination of Device 119
Mechanical Problem 90
Residue After Decontamination 83
Contamination 79
Insufficient Device Problem Information 71
Unknown (for use when the device problem is not known) 65
Failure to Disinfect 63
Fluid/Blood Leak 63
Disconnection 50

Yearly Trend

92
1992: 1
94
1994: 4
95
1995: 4
97
1997: 6
98
1998: 13
99
1999: 5
00
2000: 4
02
2002: 10
03
2003: 13
04
2004: 15
05
2005: 36
06
2006: 20
07
2007: 39
08
2008: 152
09
2009: 20
10
2010: 50
11
2011: 32
12
2012: 16
13
2013: 27
14
2014: 48
15
2015: 92
16
2016: 103
17
2017: 69
18
2018: 88
19
2019: 62
20
2020: 426
21
2021: 575
22
2022: 607
23
2023: 998
24
2024: 884
25
2025: 361
26
2026: 266

Reports fell to 361 in 2025, down from an average of 941 in the two years before.

Related Entities for Accessories, Cleaning, For Endoscope

Top Manufacturers

AIZU OLYMPUS CO., LTD. 2,683
OLYMPUS MEDICAL SYSTEMS CORP. 1,200
ADVANCED STERILIZATION PRODUCTS 187

Event Locations

3,583 (71.0%)
I 1,259 (25.0%)
HOSPITAL 126 (2.5%)
OUTPATIENT DIAGNOSTIC FACILITY 26 (0.5%)
OUTPATIENT TREATMENT FACILITY 24 (0.5%)
NO INFORMATION 16 (0.3%)
AMBULATORY SURGICAL FACILITY 5 (0.1%)
OTHER 4 (0.1%)
INVALID DATA 2 (0.0%)
UNKNOWN 1 (0.0%)

Compare AIZU OLYMPUS CO., LTD. vs OLYMPUS MEDICAL SYSTEMS CORP. →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Accessories, Cleaning, For Endoscope: 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 (5,046 here).

Monitor 5,034 Stimulator, Nerve 5,083 Ophthalmic Femtosecond Laser 5,003 Tape And Bandage, Adhesive 4,983

Similar death-typed counts

Nearest other device types by death-typed report count (22 here), distinct from the volume row.

Charger, Pacemaker 22 Device, Thermal Ablation, Endometrial 22 Endoscopic Access Overtube 22 Saline, Vascular Access Flush 22

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

Disclaimer: MAUDE figures for Accessories, Cleaning, For Endoscope 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 Accessories, Cleaning, For Endoscope; 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.