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2026 data FDA MAUDE openFDA FDA Class I

Accessories, Cleaning Brushes, 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 I (lowest regulatory risk tier, general controls), regulated under 21 CFR §876.1500 (Gastroenterology, Urology panel).

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FDA MAUDE casebook

openFDA event book Accessories, Cleaning Brushes, For Endoscope LIGHT-BOOK · MAUDE

#794 of 1000 · 664 reports · 1998–2026

  • BOOK 664 reports
  • RANK #794 of 1000
  • DEATH 0 death-typed
  • INJ 34 injury-typed
  • MALF 628 malfunction
  • SPAN 1998–2026
  • PEAK 2025: 142
  • PHOTO Endoscope Channel Acc…

Nearest event-volume peer: Endoscope Channel Accessory (2 report gap)

Accessories, Cleaning Brushes, For Endoscope sits #794 of 1000 among tracked device types with 664 MAUDE reports spanning 1998–2026. 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 Brushes, For Endoscope carries 94.6% MALFUNCTION-coded reports, 29.8pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.0% corpus 1.5% · below corpus mean (-1.5 pp)
  • INJ 5.1% corpus 30.3% · below corpus mean (-25.2 pp)
  • MALF 94.6% corpus 64.8% · above corpus mean (+29.8 pp)

Lead product-problem code Break is 51% of coded problems · Lead manufacturer BOSTON SCIENTIFIC CORPORATION accounts for 46% of manufacturer-tagged reports · Top event location is 64% of location-tagged rows .

Accessories, Cleaning Brushes, 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 Brushes, For Endoscope carries 664 MAUDE reports, ranked #794 of 1000.

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

Event Types

Malfunction 628 (94.6%)
Injury 34 (5.1%)
1 (0.2%)
Other 1 (0.2%)

Patient Outcomes

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

596 (90.0%)
Required Intervention 33 (5.0%)
Other 28 (4.2%)
Hospitalization 2 (0.3%)
H 1 (0.2%)
R 1 (0.2%)
Disability 1 (0.2%)

Top Product Problems

Break 342
Detachment of Device or Device Component 49
Detachment Of Device Component 37
Material Separation 24
Entrapment of Device 23
Adverse Event Without Identified Device or Use Problem 21
Difficult to Remove 21
Fracture 21
Material Integrity Problem 21
Device Reprocessing Problem 17
Failure to Clean Adequately 17
Device Contaminated During Manufacture or Shipping 15
Use of Device Problem 13
Material Fragmentation 12
Defective Device 9
Failure to Disconnect 8
Device Contamination with Chemical or Other Material 7
Suction Problem 7
Device Dislodged or Dislocated 6
Difficult to Insert 6

Yearly Trend

98
1998: 1
02
2002: 3
04
2004: 1
08
2008: 3
09
2009: 6
10
2010: 6
11
2011: 6
12
2012: 6
14
2014: 6
15
2015: 10
16
2016: 16
17
2017: 18
18
2018: 46
19
2019: 47
20
2020: 28
21
2021: 68
22
2022: 60
23
2023: 65
24
2024: 66
25
2025: 142
26
2026: 60

Reports rose to 142 in 2025, up from an average of 66 in the two years before - a recent-year increase, not a lifetime pattern.

Related Entities for Accessories, Cleaning Brushes, For Endoscope

Top Manufacturers

BOSTON SCIENTIFIC CORPORATION 252
SHIRAKAWA OLYMPUS CO., LTD. 110
OLYMPUS MEDICAL SYSTEMS CORP. 61
AOMORI OLYMPUS CO., LTD. 45
HOYA CORPORATION PENTAX TOKYO OFFICE 33
COOK IRELAND LTD 31
BOSTON SCIENTIFIC - MARLBOROUGH 17

Event Locations

428 (64.5%)
I 177 (26.7%)
HOSPITAL 39 (5.9%)
NO INFORMATION 12 (1.8%)
OUTPATIENT DIAGNOSTIC FACILITY 3 (0.5%)
AMBULATORY SURGICAL FACILITY 2 (0.3%)
OTHER 2 (0.3%)
INVALID DATA 1 (0.2%)

Compare BOSTON SCIENTIFIC CORPORATION vs SHIRAKAWA OLYMPUS CO., LTD. →

Nationwide devices with a comparable report-volume footprint

Accessories, Cleaning Brushes, For Endoscope carries zero death-typed MAUDE reports, so the peer set below compares report volume only; both axes are floored at ≥100 reports so the neighborhood stays in the advertised mass.

Similar report volume

Nearest other device types by FDA MAUDE report count (664 here).

Endoscope Channel Accessory 666 Instrument, Coagulation, Automated 661 Full Field Digital 659 Injector, Pen 669

Similar death-typed counts

Nearest other device types by death-typed report count (0 here), distinct from the volume row.

Aberrometer, Ophthalmic 0 Accessories, Arthroscopic 0 Accessories, Implant, Dental, Endosseous 0 Accessories, Photographic, For Endoscope 0

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

Disclaimer: MAUDE figures for Accessories, Cleaning Brushes, 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 Brushes, 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.