PlainHospital
2026 data FDA MAUDE openFDA

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.

Browse devices → Device safety hub

FDA MAUDE casebook

openFDA event book Endoscopic Access Overtube LIGHT-BOOK · MAUDE

#588 of 1000 · 1,276 reports · 1995–2026

  • BOOK 1,276 reports
  • RANK #588 of 1000
  • DEATH 20 death-typed
  • INJ 234 injury-typed
  • MALF 925 malfunction
  • SPAN 1995–2026
  • PEAK 2025: 117
  • PHOTO Disinfector

Nearest event-volume peer: Disinfector, Medical Devices (4 report gap)

Endoscopic Access Overtube, Gastroenterology-Urology sits #588 of 1000 among tracked device types with 1,276 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 →

Event-type mix vs corpus

Shares of FDA event_type codes on this device type, compared with the mean across 1,000 device types that have ≥100 MAUDE reports. Codes are report labels, not adjudicated causation.

  • DEATH 1.6% corpus 1.5% · near corpus mean (+0.0 pp)
  • INJ 18.3% corpus 30.4% · below corpus mean (-12.1 pp)
  • MALF 72.5% corpus 64.5% · above corpus mean (+8.0 pp)

Lead product-problem code Adverse Event Without Identified Device or Use Problem is 18% of coded problems · Lead manufacturer BOSTON SCIENTIFIC CORPORATION accounts for 23% of manufacturer-tagged reports · Top event location is 51% 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 1,276 MAUDE reports, ranked #588 of 1000.

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

Event Types

Malfunction 925 (72.5%)
Injury 234 (18.3%)
Other 69 (5.4%)
28 (2.2%)
Death 20 (1.6%)

Patient Outcomes

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

836 (62.2%)
Other 207 (15.4%)
Required Intervention 170 (12.7%)
Hospitalization 43 (3.2%)
R 42 (3.1%)
Death 14 (1.0%)
H 8 (0.6%)
O 7 (0.5%)
L 5 (0.4%)
Life Threatening 5 (0.4%)
D 4 (0.3%)
S 1 (0.1%)
Disability 1 (0.1%)

Top Product Problems

Adverse Event Without Identified Device or Use Problem 82
Peeled/Delaminated 81
Material Split, Cut or Torn 41
Break 32
Device Contamination with Chemical or Other Material 25
Material Integrity Problem 25
Difficult to Insert 23
Unsealed Device Packaging 19
Detachment of Device or Device Component 18
Detachment Of Device Component 12
Flaked 12
Torn Material 12
Insufficient Information 11
Material Deformation 11
Material Fragmentation 10
Accessory Incompatible 9
Difficult to Advance 9
Partial Blockage 9
Tear, Rip or Hole in Device Packaging 8
Device Contaminated During Manufacture or Shipping 7

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: 20

Related Entities for Endoscopic Access Overtube, Gastroenterology-Urology

Top Manufacturers

BOSTON SCIENTIFIC CORPORATION 102
COOK INC 90
OLYMPUS WINTER & IBE GMBH 85
C.R. BARD, INC. (COVINGTON) -1018233 59
BOSTON SCIENTIFIC - SPENCER 55
ETHICON, INC. 51

Event Locations

657 (51.5%)
HOSPITAL 392 (30.7%)
I 177 (13.9%)
INVALID DATA 19 (1.5%)
NO INFORMATION 11 (0.9%)
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 similar MAUDE profiles

Two openFDA-derived peer sets for Endoscopic Access Overtube, both floored at ≥100 reports so the neighborhoods stay in the advertised mass.

Similar report volume

Nearest other device types by FDA MAUDE report count (1,276 here).

Disinfector, Medical Devices 1,272 Agent, Occluding, Vascular, Permanent 1,271 Continuous Measurement Thermometer 1,271 Solid State X-Ray Imager 1,271

Similar death-typed counts

Nearest other device types by death-typed report count (20 here), distinct from the volume row.

Accelerator, Linear, Medical 20 Apparatus 20 Set, I.V. Fluid Transfer 20 System 20

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.