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2026 data FDA MAUDE openFDA

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.

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FDA MAUDE casebook

openFDA event book Endoscopic Guidewire LIGHT-BOOK · MAUDE

#539 of 1000 · 1,598 reports · 2007–2026

  • BOOK 1,598 reports
  • RANK #539 of 1000
  • DEATH 1 death-typed
  • INJ 281 injury-typed
  • MALF 1,311 malfunction
  • SPAN 2007–2026
  • PEAK 2015: 283
  • PHOTO Tricuspid Valve Repai…

Nearest event-volume peer: Tricuspid Valve Repair Device, Percutaneously Delivered (7 report gap)

Endoscopic Guidewire, Gastroenterology-Urology sits #539 of 1000 among tracked device types with 1,598 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 →

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 0.1% corpus 1.5% · below corpus mean (-1.5 pp)
  • INJ 17.6% corpus 30.4% · below corpus mean (-12.9 pp)
  • MALF 82.0% corpus 64.5% · above corpus mean (+17.5 pp)

Lead product-problem code Peeled/Delaminated is 40% of coded problems · Lead manufacturer BOSTON SCIENTIFIC - COSTA RICA (COYOL) accounts for 28% of manufacturer-tagged reports · Top event location I 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 1,598 MAUDE reports, ranked #539 of 1000.

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

Event Types

Malfunction 1,311 (82.0%)
Injury 281 (17.6%)
Other 3 (0.2%)
2 (0.1%)
Death 1 (0.1%)

Patient Outcomes

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

1,302 (80.0%)
Other 135 (8.3%)
Required Intervention 130 (8.0%)
Hospitalization 19 (1.2%)
R 17 (1.0%)
Life Threatening 8 (0.5%)
O 7 (0.4%)
H 4 (0.2%)
L 2 (0.1%)
D 1 (0.1%)
Death 1 (0.1%)
Disability 1 (0.1%)

Top Product Problems

Peeled/Delaminated 502
Material Separation 137
Break 132
Detachment Of Device Component 101
Adverse Event Without Identified Device or Use Problem 80
Detachment of Device or Device Component 37
Fracture 34
Material Fragmentation 27
Positioning Problem 23
Unraveled Material 23
Material Twisted/Bent 22
Material Deformation 20
Migration or Expulsion of Device 19
Insufficient Information 16
Difficult to Advance 14
Entrapment of Device 14
Improper or Incorrect Procedure or Method 12
Deformation Due to Compressive Stress 10
Device Contaminated During Manufacture or Shipping 10
Device Damaged by Another Device 10

Yearly Trend

07
2007: 3
08
2008: 7
09
2009: 6
10
2010: 8
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: 20

Related Entities for Endoscopic Guidewire, Gastroenterology-Urology

Top Manufacturers

BOSTON SCIENTIFIC - COSTA RICA (COYOL) 392
COOK INC 308
COOK ENDOSCOPY 257
WILSON-COOK MEDICAL INC 141
TERUMO CORPORATION, ASHITAKA 118
BOSTON SCIENTIFIC CORPORATION 109
TERUMO MEDICAL CORPORATION 38
WILSON-COOK MEDICAL INC. 20

Event Locations

I 688 (43.1%)
661 (41.4%)
HOSPITAL 225 (14.1%)
NO INFORMATION 20 (1.3%)
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 similar MAUDE profiles

Two openFDA-derived peer sets for Endoscopic Guidewire, 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 (1,598 here).

Tricuspid Valve Repair Device 1,605 Assay 1,611 Microfilter, Blood Transfusion 1,615 Retractor 1,615

Similar death-typed counts

Nearest other device types by death-typed report count (1 here), distinct from the volume row.

Abutment, Implant, Dental, Endosseous 1 Active Implantable Bone Conduction Hearing… 1 Aid, Surgical, Viscoelastic 1 Alarm, Conditioned Response Enuresis 1

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.