2026 data FDA MAUDE openFDA FDA Class II

Ultrasound Bronchoscope

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 §892.1550 (Radiology panel).

FDA MAUDE casebook

openFDA event book Ultrasound Bronchoscope LIGHT-BOOK · MAUDE

#293 of 1000 · 5,860 reports · 2016–2026

  • BOOK 5,860 reports
  • RANK #293 of 1000
  • DEATH 7 death-typed
  • INJ 378 injury-typed
  • MALF 5,475 malfunction
  • SPAN 2016–2026
  • PEAK 2026: 2,284
  • PHOTO Blade

Nearest event-volume peer: Blade, Saw, General & Plastic Surgery, Surgical (1 report gap)

Ultrasound Bronchoscope sits #293 of 1000 among tracked device types with 5,860 MAUDE reports spanning 2016–2026. 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

Ultrasound Bronchoscope carries 93.4% MALFUNCTION-coded reports, 28.6pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.1% corpus 1.5% · below corpus mean (-1.4 pp)
  • INJ 6.5% corpus 30.3% · below corpus mean (-23.8 pp)
  • MALF 93.4% corpus 64.8% · above corpus mean (+28.6 pp)

Lead product-problem code Detachment of Device or Device Component is 21% of coded problems · Lead manufacturer SHIRAKAWA OLYMPUS CO., LTD. accounts for 87% of manufacturer-tagged reports · Top event location is 92% of location-tagged rows .

Ultrasound Bronchoscope in the event-volume neighbourhood

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

reports

What this shows Ultrasound Bronchoscope carries 5,860 MAUDE reports, ranked #293 of 1000.

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

Event Types

Malfunction 5,475 (93.4%)
Injury 378 (6.5%)
Death 7 (0.1%)

Patient Outcomes

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

4,869 (93.0%)
Required Intervention 160 (3.1%)
Other 135 (2.6%)
O 25 (0.5%)
R 22 (0.4%)
Death 8 (0.2%)
Hospitalization 8 (0.2%)
H 5 (0.1%)
Life Threatening 3 (0.1%)
L 1 (0.0%)
Congenital Anomaly 1 (0.0%)

Top Product Problems

Detachment of Device or Device Component 1,296
No Display/Image 1,229
Failure to Clean Adequately 474
Communication or Transmission Problem 397
Poor Quality Image 375
Break 350
Device Reprocessing Problem 284
Peeled/Delaminated 241
Material Fragmentation 235
Corroded 198
Microbial Contamination of Device 171
Material Split, Cut or Torn 118
Adverse Event Without Identified Device or Use Problem 110
Material Separation 99
Material Puncture/Hole 92
Contamination 87
Erratic or Intermittent Display 86
Loss of or Failure to Bond 74
Crack 73
Display or Visual Feedback Problem 69

Yearly Trend

16
2016: 16
17
2017: 15
18
2018: 37
19
2019: 23
20
2020: 149
21
2021: 134
22
2022: 367
23
2023: 717
24
2024: 627
25
2025: 1,491
26
2026: 2,284

Reports rose to 1,491 in 2025, up from an average of 672 in the two years before - a recent-year increase, not a lifetime pattern.

Related Entities for Ultrasound Bronchoscope

Event Locations

5,399 (92.1%)
I 315 (5.4%)
HOSPITAL 144 (2.5%)
NO INFORMATION 1 (0.0%)
OTHER 1 (0.0%)

Compare SHIRAKAWA OLYMPUS CO., LTD. vs OLYMPUS MEDICAL SYSTEMS CORP. →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Ultrasound Bronchoscope: 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 (5,860 here).

Similar death-typed counts

Nearest other device types by death-typed report count (7 here), distinct from the volume row.

Disclaimer: MAUDE figures for Ultrasound Bronchoscope 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 Ultrasound Bronchoscope; 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.