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2026 data FDA MAUDE openFDA FDA Class II

Endoscopic Guidewire, 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 Guidewire LIGHT-BOOK · MAUDE

#547 of 1000 · 1,635 reports · 2007–2026

  • BOOK 1,635 reports
  • RANK #547 of 1000
  • DEATH 3 death-typed
  • INJ 291 injury-typed
  • MALF 1,336 malfunction
  • SPAN 2007–2026
  • PEAK 2015: 283
  • PHOTO Cement, Dental

Nearest event-volume peer: Cement, Dental (5 report gap)

Endoscopic Guidewire, Gastroenterology-Urology sits #547 of 1000 among tracked device types with 1,635 MAUDE reports spanning 2007–2026. 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 Guidewire carries 81.7% MALFUNCTION-coded reports, 16.9pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.2% corpus 1.5% · below corpus mean (-1.3 pp)
  • INJ 17.8% corpus 30.3% · below corpus mean (-12.5 pp)
  • MALF 81.7% corpus 64.8% · above corpus mean (+16.9 pp)

Lead product-problem code Peeled/Delaminated is 34% of coded problems · Lead manufacturer BOSTON SCIENTIFIC - COSTA RICA (COYOL) accounts for 28% of manufacturer-tagged reports · Top event location is 43% of location-tagged rows .

Endoscopic Guidewire in the event-volume neighbourhood

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

reports

What this shows Endoscopic Guidewire, Gastroenterology-Urology carries 1,635 MAUDE reports, ranked #547 of 1000.

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

Event Types

Malfunction 1,336 (81.7%)
Injury 291 (17.8%)
Death 3 (0.2%)
Other 3 (0.2%)
2 (0.1%)

Patient Outcomes

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

1,324 (79.6%)
Other 141 (8.5%)
Required Intervention 133 (8.0%)
Hospitalization 21 (1.3%)
R 19 (1.1%)
O 8 (0.5%)
Life Threatening 8 (0.5%)
H 5 (0.3%)
L 2 (0.1%)
D 1 (0.1%)
Death 1 (0.1%)
Disability 1 (0.1%)

Top Product Problems

Peeled/Delaminated 563
Detachment Of Device Component 387
Material Separation 165
Break 140
Adverse Event Without Identified Device or Use Problem 90
Detachment of Device or Device Component 42
Fracture 35
Material Fragmentation 29
Unraveled Material 25
Material Twisted/Bent 23
Positioning Problem 23
Material Deformation 21
Migration or Expulsion of Device 21
Difficult to Advance 19
Insufficient Device Problem Information 16
Entrapment of Device 14
Improper or Incorrect Procedure or Method 13
Difficult to Remove 11
Flaked 11
Unsealed Device Packaging 11

Yearly Trend

07
2007: 3
08
2008: 7
09
2009: 7
10
2010: 9
11
2011: 3
12
2012: 1
13
2013: 32
14
2014: 51
15
2015: 283
16
2016: 158
17
2017: 85
18
2018: 101
19
2019: 103
20
2020: 128
21
2021: 94
22
2022: 134
23
2023: 115
24
2024: 131
25
2025: 135
26
2026: 55

Reports in 2025 (135) held close to the prior two-year average of 123.

Related Entities for Endoscopic Guidewire, Gastroenterology-Urology

Top Manufacturers

BOSTON SCIENTIFIC - COSTA RICA (COYOL) 392
COOK INC 316
COOK ENDOSCOPY 257
WILSON-COOK MEDICAL INC 143
BOSTON SCIENTIFIC CORPORATION 123
TERUMO CORPORATION, ASHITAKA 122
TERUMO MEDICAL CORPORATION 38
WILSON-COOK MEDICAL INC. 20

Event Locations

696 (42.6%)
I 688 (42.1%)
HOSPITAL 227 (13.9%)
NO INFORMATION 20 (1.2%)
OTHER 2 (0.1%)
AMBULATORY SURGICAL FACILITY 1 (0.1%)
OUTPATIENT TREATMENT FACILITY 1 (0.1%)

Compare BOSTON SCIENTIFIC - COSTA RICA (COYOL) vs COOK INC →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Endoscopic Guidewire: 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 (1,635 here).

Cement, Dental 1,630 Retractor 1,646 Microfilter, Blood Transfusion 1,648 Set, Tubing And Support, Ventilator 1,654

Similar death-typed counts

Nearest other device types by death-typed report count (3 here), distinct from the volume row.

Analyzer, Pacemaker Generator Function 3 Apparatus, Traction, Non-Powered 3 Bronchial Thermoplasty System 3 Bur, Ear, Nose And Throat 3

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

Disclaimer: MAUDE figures for Endoscopic Guidewire 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 Guidewire; 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.