2026 data FDA MAUDE openFDA

Transducer, Ultrasonic, Diagnostic

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 MAUDE casebook

openFDA event book Transducer, Ultrasonic, Diagnostic LIGHT-BOOK · MAUDE

#362 of 1000 · 3,642 reports · 1994–2026

  • BOOK 3,642 reports
  • RANK #362 of 1000
  • DEATH 23 death-typed
  • INJ 316 injury-typed
  • MALF 3,227 malfunction
  • SPAN 1994–2026
  • PEAK 2024: 988
  • PHOTO Stapler, Skin

Nearest event-volume peer: Stapler, Skin (3 report gap)

Transducer, Ultrasonic, Diagnostic sits #362 of 1000 among tracked device types with 3,642 MAUDE reports spanning 1994–2026. 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 0.6% corpus 1.5% · below corpus mean (-0.9 pp)
  • INJ 8.7% corpus 30.4% · below corpus mean (-21.8 pp)
  • MALF 88.6% corpus 64.5% · above corpus mean (+24.1 pp)

Lead product-problem code Poor Quality Image is 46% of coded problems · Lead manufacturer SHIRAKAWA OLYMPUS CO., LTD. accounts for 49% of manufacturer-tagged reports · Top event location is 63% of location-tagged rows .

Transducer, Ultrasonic, Diagnostic in the event-volume neighbourhood

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

reports

What this shows Transducer, Ultrasonic, Diagnostic carries 3,642 MAUDE reports, ranked #362 of 1000.

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

Event Types

Malfunction 3,227 (88.6%)
Injury 316 (8.7%)
Other 58 (1.6%)
Death 23 (0.6%)
18 (0.5%)

Patient Outcomes

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

2,969 (80.2%)
Other 428 (11.6%)
Required Intervention 144 (3.9%)
Hospitalization 53 (1.4%)
R 31 (0.8%)
Death 21 (0.6%)
O 14 (0.4%)
Life Threatening 13 (0.4%)
L 10 (0.3%)
H 6 (0.2%)
S 5 (0.1%)
Congenital Anomaly 3 (0.1%)
Disability 3 (0.1%)
D 1 (0.0%)

Top Product Problems

Poor Quality Image 1,183
Device Displays Incorrect Message 305
Break 178
Adverse Event Without Identified Device or Use Problem 108
Leak/Splash 90
Device Operates Differently Than Expected 78
No Display/Image 74
Material Deformation 70
Fluid/Blood Leak 67
Material Twisted/Bent 66
Detachment of Device or Device Component 59
Defective Component 42
Deformation Due to Compressive Stress 40
Use of Device Problem 40
Entrapment of Device 37
Mechanical Problem 36
Material Split, Cut or Torn 35
Failure to Clean Adequately 32
No Apparent Adverse Event 30
Material Puncture/Hole 28

Yearly Trend

94
1994: 2
95
1995: 1
96
1996: 2
97
1997: 14
98
1998: 6
99
1999: 13
00
2000: 10
01
2001: 11
02
2002: 15
03
2003: 14
04
2004: 22
05
2005: 16
06
2006: 20
07
2007: 16
08
2008: 39
09
2009: 23
10
2010: 30
11
2011: 34
12
2012: 29
13
2013: 38
14
2014: 43
15
2015: 183
16
2016: 269
17
2017: 412
18
2018: 130
19
2019: 119
20
2020: 116
21
2021: 146
22
2022: 87
23
2023: 138
24
2024: 988
25
2025: 575
26
2026: 81

Related Entities for Transducer, Ultrasonic, Diagnostic

Event Locations

2,310 (63.4%)
I 856 (23.5%)
HOSPITAL 351 (9.6%)
NO INFORMATION 76 (2.1%)
HOME 11 (0.3%)
OTHER 11 (0.3%)
INVALID DATA 8 (0.2%)
UNKNOWN 8 (0.2%)
OUTPATIENT TREATMENT FACILITY 5 (0.1%)
AMBULATORY SURGICAL FACILITY 2 (0.1%)
OUTPATIENT DIAGNOSTIC FACILITY 2 (0.1%)
CLINIC - WALK IN, OTHER 1 (0.0%)
NOT APPLICABLE 1 (0.0%)

Compare SHIRAKAWA OLYMPUS CO., LTD. vs C.R. BARD, INC. (BASD) -3006260740 →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Transducer, Ultrasonic, Diagnostic, 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 (3,642 here).

Similar death-typed counts

Nearest other device types by death-typed report count (23 here), distinct from the volume row.

Disclaimer: MAUDE figures for Transducer, Ultrasonic, Diagnostic 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 Transducer, Ultrasonic, Diagnostic; 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.