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2026 data FDA MAUDE openFDA FDA Class II

Endoscopic Cytology Brush

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 Endoscopic Cytology Brush LIGHT-BOOK · MAUDE

#781 of 1000 · 695 reports · 1992–2026

  • BOOK 695 reports
  • RANK #781 of 1000
  • DEATH 5 death-typed
  • INJ 108 injury-typed
  • MALF 577 malfunction
  • SPAN 1992–2026
  • PEAK 2019: 67
  • PHOTO Subsystem

Nearest event-volume peer: Subsystem, Water Purification (1 report gap)

Endoscopic Cytology Brush sits #781 of 1000 among tracked device types with 695 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

Endoscopic Cytology Brush carries 83.0% MALFUNCTION-coded reports, 18.2pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.7% corpus 1.5% · below corpus mean (-0.8 pp)
  • INJ 15.5% corpus 30.3% · below corpus mean (-14.8 pp)
  • MALF 83.0% corpus 64.8% · above corpus mean (+18.2 pp)

Lead product-problem code Break is 22% of coded problems · Lead manufacturer BOSTON SCIENTIFIC - SPENCER accounts for 62% of manufacturer-tagged reports · Top event location is 57% of location-tagged rows .

Endoscopic Cytology Brush in the event-volume neighbourhood

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

reports

What this shows Endoscopic Cytology Brush carries 695 MAUDE reports, ranked #781 of 1000.

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

Event Types

Malfunction 577 (83.0%)
Injury 108 (15.5%)
Death 5 (0.7%)
3 (0.4%)
Other 2 (0.3%)

Patient Outcomes

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

552 (75.7%)
Required Intervention 80 (11.0%)
Other 36 (4.9%)
R 18 (2.5%)
Hospitalization 17 (2.3%)
H 6 (0.8%)
O 6 (0.8%)
Death 6 (0.8%)
L 5 (0.7%)
Disability 2 (0.3%)
Invalid Data 1 (0.1%)

Top Product Problems

Break 164
Bent 98
Retraction Problem 94
Detachment Of Device Component 93
Detachment of Device or Device Component 72
Adverse Event Without Identified Device or Use Problem 49
Material Twisted/Bent 41
Mechanical Problem 23
Material Separation 19
Patient-Device Incompatibility 18
Device, or device fragments remain in patient 13
Replace 12
Tip breakage 12
Material Deformation 11
Torn Material 8
Failure to Advance 7
Wire(s), breakage of 7
Component Falling 6
Device, removal of (non-implant) 6
Difficult to Remove 6

Yearly Trend

92
1992: 1
94
1994: 3
96
1996: 1
97
1997: 3
98
1998: 1
99
1999: 4
00
2000: 4
01
2001: 20
02
2002: 6
03
2003: 1
04
2004: 6
05
2005: 4
06
2006: 5
07
2007: 6
08
2008: 14
09
2009: 37
10
2010: 37
11
2011: 36
12
2012: 28
13
2013: 45
14
2014: 61
15
2015: 62
16
2016: 45
17
2017: 44
18
2018: 48
19
2019: 67
20
2020: 13
21
2021: 19
22
2022: 17
23
2023: 17
24
2024: 20
25
2025: 11
26
2026: 9

Reports fell to 11 in 2025, down from an average of 19 in the two years before.

Related Entities for Endoscopic Cytology Brush

Top Manufacturers

BOSTON SCIENTIFIC - SPENCER 313
BOSTON SCIENTIFIC CORPORATION 156
COOK ENDOSCOPY 22
WILSON-COOK MEDICAL INC 10
BOSTON SCIENTIFIC 6

Event Locations

398 (57.3%)
I 242 (34.8%)
HOSPITAL 47 (6.8%)
NO INFORMATION 3 (0.4%)
OTHER 2 (0.3%)
AMBULATORY SURGICAL FACILITY 1 (0.1%)
INVALID DATA 1 (0.1%)
OUTPATIENT DIAGNOSTIC FACILITY 1 (0.1%)

Compare BOSTON SCIENTIFIC - SPENCER vs BOSTON SCIENTIFIC CORPORATION →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Endoscopic Cytology Brush: 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 (695 here).

Subsystem, Water Purification 696 Endoscope, Ac-Powered And Accessories 697 Accessories, Photographic, For Endoscope 698 Lectins And Protectins 701

Similar death-typed counts

Nearest other device types by death-typed report count (5 here), distinct from the volume row.

Anesthesia Conduction Kit 5 Antigens, All Groups, Streptococcus Spp. 5 Apparatus, Exhaust, Surgical 5 Bit, Drill 5

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

Disclaimer: MAUDE figures for Endoscopic Cytology Brush 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 Endoscopic Cytology Brush; 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.