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2026 data FDA MAUDE openFDA

Endoscopic Ultrasound System, Gastroenterology-Urology

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

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FDA MAUDE casebook

openFDA event book Endoscopic Ultrasound System MID-BOOK · MAUDE

#187 of 1000 · 12,569 reports · 2008–2026

  • BOOK 12,569 reports
  • RANK #187 of 1000
  • DEATH 31 death-typed
  • INJ 309 injury-typed
  • MALF 12,226 malfunction
  • SPAN 2008–2026
  • PEAK 2025: 3,581
  • PHOTO Electrode, Ph, Stomach

Nearest event-volume peer: Electrode, Ph, Stomach (20 report gap)

Endoscopic Ultrasound System, Gastroenterology-Urology sits #187 of 1000 among tracked device types with 12,569 MAUDE reports spanning 2008–2026. 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 0.2% corpus 1.5% · below corpus mean (-1.3 pp)
  • INJ 2.5% corpus 30.4% · below corpus mean (-28.0 pp)
  • MALF 97.3% corpus 64.5% · above corpus mean (+32.8 pp)

Lead product-problem code Peeled/Delaminated is 14% of coded problems · Lead manufacturer SHIRAKAWA OLYMPUS CO., LTD. accounts for 62% of manufacturer-tagged reports · Top event location is 87% of location-tagged rows .

Endoscopic Ultrasound System in the event-volume neighbourhood

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

reports

What this shows Endoscopic Ultrasound System, Gastroenterology-Urology carries 12,569 MAUDE reports, ranked #187 of 1000.

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

Event Types

Malfunction 12,226 (97.3%)
Injury 309 (2.5%)
Death 31 (0.2%)
Other 3 (0.0%)

Patient Outcomes

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

12,199 (96.7%)
Other 146 (1.2%)
Required Intervention 95 (0.8%)
Hospitalization 57 (0.5%)
R 42 (0.3%)
Death 27 (0.2%)
O 26 (0.2%)
H 19 (0.2%)
D 5 (0.0%)
L 1 (0.0%)
Disability 1 (0.0%)
Life Threatening 1 (0.0%)

Top Product Problems

Peeled/Delaminated 1,955
Material Split, Cut or Torn 1,613
Detachment of Device or Device Component 1,564
Break 1,165
Failure to Clean Adequately 1,050
Microbial Contamination of Device 952
Crack 740
Material Separation 675
Fluid/Blood Leak 628
No Display/Image 595
Obstruction of Flow 478
Device Reprocessing Problem 378
Degraded 268
Component Missing 260
Material Puncture/Hole 235
Scratched Material 227
Adverse Event Without Identified Device or Use Problem 220
Erratic or Intermittent Display 220
Contamination 213
Optical Obstruction 188

Yearly Trend

08
2008: 1
09
2009: 3
10
2010: 2
11
2011: 13
12
2012: 6
13
2013: 2
14
2014: 1
15
2015: 11
16
2016: 50
17
2017: 82
18
2018: 66
19
2019: 96
20
2020: 445
21
2021: 1,234
22
2022: 1,832
23
2023: 2,078
24
2024: 1,904
25
2025: 3,581
26
2026: 1,162

Related Entities for Endoscopic Ultrasound System, Gastroenterology-Urology

Top Manufacturers

SHIRAKAWA OLYMPUS CO., LTD. 7,703
HOYA CORPORATION PENTAX TOKYO OFFICE 2,368
OLYMPUS MEDICAL SYSTEMS CORP. 2,222
BOSTON SCIENTIFIC CORPORATION 72
SHIRAKAWA OLYMPUS CO., LTD 46
BOSTON SCIENTIFIC - SPENCER 17
BOSTON SCIENTIFIC - MARLBOROUGH 13
AOMORI OLYMPUS CO., LTD. 9

Event Locations

10,990 (87.4%)
I 1,495 (11.9%)
HOSPITAL 72 (0.6%)
AMBULATORY SURGICAL FACILITY 4 (0.0%)
OTHER 3 (0.0%)
OUTPATIENT DIAGNOSTIC FACILITY 3 (0.0%)
NO INFORMATION 1 (0.0%)
OUTPATIENT TREATMENT FACILITY 1 (0.0%)

Compare SHIRAKAWA OLYMPUS CO., LTD. vs HOYA CORPORATION PENTAX TOKYO OFFICE →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Endoscopic Ultrasound System, 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 (12,569 here).

Electrode, Ph, Stomach 12,589 Prosthesis, Hip, Femoral, Resurfacing 12,475 Endoscope, Accessories, Narrow Band Spectrum 12,449 Clamp, Vascular 12,430

Similar death-typed counts

Nearest other device types by death-typed report count (31 here), distinct from the volume row.

Dorsal Root Ganglion Stimulator For Pain Re… 31 Intrasaccular Flow Disruption Device 31 Stimulator, Carotid Sinus Nerve 31 System 31

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

Disclaimer: MAUDE figures for Endoscopic Ultrasound System 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 Ultrasound System; 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.