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2026 data FDA MAUDE openFDA FDA Class II

Endoscopic Access Overtube, Gastroenterology-Urology

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 Access Overtube LIGHT-BOOK · MAUDE

#602 of 1000 · 1,312 reports · 1995–2026

  • BOOK 1,312 reports
  • RANK #602 of 1000
  • DEATH 22 death-typed
  • INJ 243 injury-typed
  • MALF 950 malfunction
  • SPAN 1995–2026
  • PEAK 2025: 117
  • PHOTO Disinfector

Nearest event-volume peer: Disinfector, Medical Devices (3 report gap)

Endoscopic Access Overtube, Gastroenterology-Urology sits #602 of 1000 among tracked device types with 1,312 MAUDE reports spanning 1995–2026. 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 →

Injury-coded reports sit below the device-type norm

Endoscopic Access Overtube carries 18.5% INJURY-coded reports, 11.8pp below the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 1.7% corpus 1.5% · near corpus mean (+0.2 pp)
  • INJ 18.5% corpus 30.3% · below corpus mean (-11.8 pp)
  • MALF 72.4% corpus 64.8% · above corpus mean (+7.6 pp)

Lead product-problem code Tip breakage is 20% of coded problems · Lead manufacturer BOSTON SCIENTIFIC CORPORATION accounts for 23% of manufacturer-tagged reports · Top event location is 53% of location-tagged rows .

Endoscopic Access Overtube in the event-volume neighbourhood

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

reports

What this shows Endoscopic Access Overtube, Gastroenterology-Urology carries 1,312 MAUDE reports, ranked #602 of 1000.

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

Event Types

Malfunction 950 (72.4%)
Injury 243 (18.5%)
Other 69 (5.3%)
28 (2.1%)
Death 22 (1.7%)

Patient Outcomes

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

857 (61.9%)
Other 210 (15.2%)
Required Intervention 178 (12.9%)
Hospitalization 46 (3.3%)
R 44 (3.2%)
Death 15 (1.1%)
H 9 (0.6%)
O 8 (0.6%)
L 6 (0.4%)
D 5 (0.4%)
Life Threatening 5 (0.4%)
S 1 (0.1%)
Disability 1 (0.1%)

Top Product Problems

Tip breakage 257
Break 208
Detachment Of Device Component 128
Adverse Event Without Identified Device or Use Problem 98
Peeled/Delaminated 85
Difficult to Insert 63
Material Separation 55
Material Split, Cut or Torn 52
Device, or device fragments remain in patient 48
Difficult to Remove 38
Replace 36
Component(s), broken 31
Device Contamination with Chemical or Other Material 31
Material Integrity Problem 30
Detachment of Device or Device Component 29
Device, removal of (non-implant) 29
Component Falling 24
Material Fragmentation 23
Material Deformation 21
Unsealed Device Packaging 20

Yearly Trend

95
1995: 1
96
1996: 14
97
1997: 39
98
1998: 44
99
1999: 43
00
2000: 68
01
2001: 71
02
2002: 47
03
2003: 66
04
2004: 64
05
2005: 55
06
2006: 42
07
2007: 14
08
2008: 18
09
2009: 19
10
2010: 19
11
2011: 20
12
2012: 35
13
2013: 25
14
2014: 34
15
2015: 35
16
2016: 29
17
2017: 32
18
2018: 34
19
2019: 30
20
2020: 33
21
2021: 55
22
2022: 36
23
2023: 53
24
2024: 64
25
2025: 117
26
2026: 56

Reports rose to 117 in 2025, up from an average of 59 in the two years before - a recent-year increase, not a lifetime pattern.

Related Entities for Endoscopic Access Overtube, Gastroenterology-Urology

Top Manufacturers

BOSTON SCIENTIFIC CORPORATION 103
COOK INC 93
OLYMPUS WINTER & IBE GMBH 85
C.R. BARD, INC. (COVINGTON) -1018233 59
BOSTON SCIENTIFIC - SPENCER 55
ETHICON, INC. 51

Event Locations

690 (52.6%)
HOSPITAL 395 (30.1%)
I 177 (13.5%)
INVALID DATA 19 (1.4%)
NO INFORMATION 11 (0.8%)
AMBULATORY SURGICAL FACILITY 7 (0.5%)
OTHER 4 (0.3%)
OUTPATIENT DIAGNOSTIC FACILITY 4 (0.3%)
NOT APPLICABLE 3 (0.2%)
OUTPATIENT TREATMENT FACILITY 1 (0.1%)
UNKNOWN 1 (0.1%)

Compare BOSTON SCIENTIFIC CORPORATION vs COOK INC →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Endoscopic Access Overtube: 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 (1,312 here).

Disinfector, Medical Devices 1,315 Needle, Conduction, Anesthetic 1,308 Pump, Air, Non-Manual, For Endoscope 1,316 Peripheral Mechanical Thrombectomy With Asp… 1,318

Similar death-typed counts

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

Accessories, Cleaning, For Endoscope 22 Charger, Pacemaker 22 Device, Thermal Ablation, Endometrial 22 Saline, Vascular Access Flush 22

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

Disclaimer: MAUDE figures for Endoscopic Access Overtube 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 Access Overtube; 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.