What are FDA adverse event reports for Dilator, Esophageal?

The FDA's MAUDE (Manufacturer and User Facility Device Experience) database collects reports of adverse events involving medical devices. For Dilator, Esophageal, there are 5,077 total reports including 16 death reports and 448 injury reports. These reports are submitted by manufacturers, healthcare facilities, and patients. A high number of reports does not necessarily mean a device is unsafe, widely used devices naturally generate more reports.

How should I interpret MAUDE data for Dilator, Esophageal?

MAUDE reports are raw adverse event submissions, not confirmed safety findings. A report that a device was involved in a death does not mean the device caused the death. Reports vary in quality and completeness. The FDA uses MAUDE data as one input among many in its safety surveillance, it does not draw conclusions from individual reports. Always consult your healthcare provider about device safety questions.

2026 data FDA MAUDE openFDA

Dilator, Esophageal

Name: Dilator, Esophageal - FDA MAUDE Adverse Event Reports
Creator: PlainHospital
License: https://creativecommons.org/publicdomain/zero/1.0/

Adverse-event figures are drawn from the U.S. Food & Drug Administration (FDA) MAUDE database, refreshed March 2026, see our methodology.

Compiled by PlainHospital · August 14, 2026

OpenFDA device adverse-event casebook.

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FDA MAUDE casebook

openFDA event book Dilator, Esophageal LIGHT-BOOK · MAUDE

#309 of 1000 · 5,077 reports · 1993–2026

BOOK 5,077 reports
RANK #309 of 1000
DEATH 16 death-typed
INJ 448 injury-typed
MALF 4,593 malfunction
SPAN 1993–2026
PEAK 2018: 396
PHOTO Anesthesia Conduction…

Nearest event-volume peer: Anesthesia Conduction Kit (15 report gap)

Dilator, Esophageal sits #309 of 1000 among tracked device types with 5,077 MAUDE reports spanning 1993–2026. 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 0.3% corpus 1.5% · below corpus mean (-1.2 pp)
INJ 8.8% corpus 30.4% · below corpus mean (-21.6 pp)
MALF 90.5% corpus 64.5% · above corpus mean (+26.0 pp)

Lead product-problem code Burst Container or Vessel is 21% of coded problems · Lead manufacturer BOSTON SCIENTIFIC CORPORATION accounts for 42% of manufacturer-tagged reports · Top event location is 54% of location-tagged rows .

Anesthesia Co…

5,092
Light

5,092
Dilator (this)

5,077
Expander

5,056
Prosthesis

5,047
Prosthesis

5,047

What this shows Dilator, Esophageal carries 5,077 MAUDE reports, ranked #309 of 1000.

Event Types

Malfunction 4,593 (90.5%)

Injury 448 (8.8%)

Death 16 (0.3%)

Other 13 (0.3%)

7 (0.1%)

Patient Outcomes

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

4,556 (88.4%)

Required Intervention 320 (6.2%)

Other 88 (1.7%)

Hospitalization 77 (1.5%)

R 58 (1.1%)

Death 14 (0.3%)

Life Threatening 11 (0.2%)

O 9 (0.2%)

H 7 (0.1%)

L 7 (0.1%)

Disability 5 (0.1%)

S 3 (0.1%)

Yearly Trend

1993: 1

1994: 2

1995: 4

1996: 15

1997: 13

1998: 15

1999: 12

2000: 5

2001: 11

2002: 12

2003: 5

2004: 14

2005: 24

2006: 38

2007: 22

2008: 128

2009: 390

2010: 177

2011: 251

2012: 251

2013: 228

2014: 164

2015: 204

2016: 154

2017: 231

2018: 396

2019: 388

2020: 364

2021: 351

2022: 274

2023: 319

2024: 268

2025: 284

2026: 62

Top Manufacturers

BOSTON SCIENTIFIC CORPORATION 1,689

COOK ENDOSCOPY 681

WILSON-COOK MEDICAL INC 520

BOSTON SCIENTIFIC - CORK 388

BOSTON SCIENTIFIC - GALWAY 253

WILSON-COOK MEDICAL INC. 239

BOSTON SCIENTIFIC 113

GYRUS ACMI, INC. 113

WILSON-COOK MEDICAL, INC. 67

Event Locations

2,725 (53.7%)

I 1,631 (32.1%)

HOSPITAL 645 (12.7%)

NO INFORMATION 34 (0.7%)

AMBULATORY SURGICAL FACILITY 11 (0.2%)

OUTPATIENT TREATMENT FACILITY 10 (0.2%)

OUTPATIENT DIAGNOSTIC FACILITY 8 (0.2%)

INVALID DATA 7 (0.1%)

OTHER 4 (0.1%)

NOT APPLICABLE 1 (0.0%)

UNKNOWN 1 (0.0%)

Compare BOSTON SCIENTIFIC CORPORATION vs COOK ENDOSCOPY →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Dilator, Esophageal, 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 (5,077 here).

Anesthesia Conduction Kit 5,092 Light, Surgical, Ceiling Mounted 5,092 Expander, Surgical, Skin Graft 5,056 Prosthesis 5,047

Similar death-typed counts

Nearest other device types by death-typed report count (16 here), distinct from the volume row.

Computer 16 Gastrointestinal Tubes With Enteral Specifi… 16 Implanted Subcortical Electrical Stimulator 16 Accessories, Blood Circuit, Hemodialysis 17

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

Disclaimer: MAUDE figures for Dilator, Esophageal 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 Dilator, Esophageal; 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.

Dilator, Esophageal

Event-type mix vs corpus