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2026 data FDA MAUDE openFDA FDA Class II

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.

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 Ultrasound System MID-BOOK · MAUDE

#168 of 1000 · 16,331 reports · 2008–2026

  • BOOK 16,331 reports
  • RANK #168 of 1000
  • DEATH 31 death-typed
  • INJ 314 injury-typed
  • MALF 15,983 malfunction
  • SPAN 2008–2026
  • PEAK 2026: 4,924
  • PHOTO Prosthesis

Nearest event-volume peer: Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer (1 report gap)

Endoscopic Ultrasound System, Gastroenterology-Urology sits #168 of 1000 among tracked device types with 16,331 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 →

Malfunction reports run above the device-type norm

Endoscopic Ultrasound System carries 97.9% MALFUNCTION-coded reports, 33.0pp 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 1.9% corpus 30.3% · below corpus mean (-28.4 pp)
  • MALF 97.9% corpus 64.8% · above corpus mean (+33.0 pp)

Lead product-problem code Detachment of Device or Device Component is 15% of coded problems · Lead manufacturer SHIRAKAWA OLYMPUS CO., LTD. accounts for 70% of manufacturer-tagged reports · Top event location is 90% 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 16,331 MAUDE reports, ranked #168 of 1000.

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

Event Types

Malfunction 15,983 (97.9%)
Injury 314 (1.9%)
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.

15,869 (97.4%)
Other 146 (0.9%)
Required Intervention 97 (0.6%)
Hospitalization 58 (0.4%)
R 43 (0.3%)
Death 27 (0.2%)
O 26 (0.2%)
H 20 (0.1%)
D 5 (0.0%)
L 1 (0.0%)
Disability 1 (0.0%)
Life Threatening 1 (0.0%)

Top Product Problems

Detachment of Device or Device Component 2,765
Peeled/Delaminated 2,321
Material Split, Cut or Torn 2,295
Break 1,437
Crack 1,314
Failure to Clean Adequately 1,295
Microbial Contamination of Device 1,024
Material Separation 850
No Display/Image 729
Degraded 683
Fluid/Blood Leak 651
Material Puncture/Hole 551
Obstruction of Flow 490
Device Reprocessing Problem 489
Scratched Material 341
Component Missing 284
Corroded 282
Residue After Decontamination 281
Material Fragmentation 274
Adverse Event Without Identified Device or Use Problem 234

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: 4,924

Reports rose to 3,581 in 2025, up from an average of 1,991 in the two years before - a recent-year increase, not a lifetime pattern.

Related Entities for Endoscopic Ultrasound System, Gastroenterology-Urology

Top Manufacturers

SHIRAKAWA OLYMPUS CO., LTD. 11,396
HOYA CORPORATION PENTAX TOKYO OFFICE 2,425
OLYMPUS MEDICAL SYSTEMS CORP. 2,222
BOSTON SCIENTIFIC CORPORATION 77
SHIRAKAWA OLYMPUS CO., LTD 46
BOSTON SCIENTIFIC - SPENCER 17
BOSTON SCIENTIFIC - MARLBOROUGH 13
AOMORI OLYMPUS CO., LTD. 9

Event Locations

14,751 (90.3%)
I 1,495 (9.2%)
HOSPITAL 73 (0.4%)
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 a comparable volume-and-death footprint

Two openFDA-derived peer sets for Endoscopic Ultrasound System: 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 (16,331 here).

Prosthesis 16,332 Catheter, Urological And Accessories 16,326 Cardiac Ablation Percutaneous Catheter 16,442 Prosthesis 16,505

Similar death-typed counts

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

Over-The-Counter Automated External Defibri… 31 Stimulator, Carotid Sinus Nerve 31 System 31 Apparatus, Nitric Oxide Delivery 30

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.