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2026 data FDA MAUDE openFDA

Instrument, Ultrasonic Surgical

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.

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FDA MAUDE casebook

openFDA event book Instrument, Ultrasonic Surgical MID-BOOK · MAUDE

#56 of 1000 · 66,379 reports · 1995–2026

  • BOOK 66,379 reports
  • RANK #56 of 1000
  • DEATH 81 death-typed
  • INJ 3,002 injury-typed
  • MALF 62,973 malfunction
  • SPAN 1995–2026
  • PEAK 2014: 4,260
  • PHOTO System

Nearest event-volume peer: System, Balloon, Intra-Aortic And Control (1,960 report gap)

Instrument, Ultrasonic Surgical sits #56 of 1000 among tracked device types with 66,379 MAUDE reports spanning 1995–2026. 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 0.1% corpus 1.5% · below corpus mean (-1.4 pp)
  • INJ 4.5% corpus 30.4% · below corpus mean (-25.9 pp)
  • MALF 94.9% corpus 64.5% · above corpus mean (+30.4 pp)

Lead product-problem code Material Separation is 20% of coded problems · Lead manufacturer ETHICON ENDO-SURGERY, LLC. accounts for 69% of manufacturer-tagged reports · Top event location is 45% of location-tagged rows .

Instrument, Ultrasonic Surgical in the event-volume neighbourhood

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

reports

What this shows Instrument, Ultrasonic Surgical carries 66,379 MAUDE reports, ranked #56 of 1000.

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

Event Types

Malfunction 62,973 (94.9%)
Injury 3,002 (4.5%)
260 (0.4%)
Death 81 (0.1%)
Other 62 (0.1%)
No answer provided 1 (0.0%)

Patient Outcomes

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

59,263 (89.0%)
Other 5,225 (7.9%)
Required Intervention 1,569 (2.4%)
R 141 (0.2%)
Hospitalization 117 (0.2%)
Death 84 (0.1%)
Disability 56 (0.1%)
O 45 (0.1%)
Life Threatening 19 (0.0%)
H 18 (0.0%)
L 17 (0.0%)
D 1 (0.0%)
S 1 (0.0%)

Top Product Problems

Material Separation 6,612
Break 6,120
Failure to Read Input Signal 5,121
Detachment of Device or Device Component 4,008
Device Displays Incorrect Message 1,560
Difficult or Delayed Activation 1,323
Detachment Of Device Component 1,214
Material Integrity Problem 967
Adverse Event Without Identified Device or Use Problem 763
Fracture 664
Insufficient Information 563
Activation, Positioning or Separation Problem 559
Component Falling 507
Peeled/Delaminated 496
Device Operates Differently Than Expected 471
Inappropriate or Unexpected Reset 461
Overheating of Device 412
Noise, Audible 401
Failure to Fire 396
Patient Device Interaction Problem 389

Yearly Trend

95
1995: 1
97
1997: 3
98
1998: 82
99
1999: 108
00
2000: 1,018
01
2001: 2,744
02
2002: 336
03
2003: 297
04
2004: 1,628
05
2005: 2,445
06
2006: 2,197
07
2007: 2,236
08
2008: 1,679
09
2009: 3,324
10
2010: 1,239
11
2011: 1,053
12
2012: 1,492
13
2013: 2,430
14
2014: 4,260
15
2015: 2,777
16
2016: 2,691
17
2017: 3,267
18
2018: 3,461
19
2019: 3,153
20
2020: 2,934
21
2021: 3,289
22
2022: 3,422
23
2023: 4,215
24
2024: 4,017
25
2025: 3,907
26
2026: 674

Related Entities for Instrument, Ultrasonic Surgical

Top Manufacturers

ETHICON ENDO-SURGERY, LLC. 37,670
ETHICON ENDO-SURGERY, INC. (CINCINNATI) 3,030
ETHICON ENDO-SURGERY, LLC 2,851
ETHICON ENDO SURGERY, INC. (CINCINNATI) 2,561
ETHICON ENDO-SURGERY 2,018
ETHICON ENDO-SURGERY - ALB 1,718
OLYMPUS MEDICAL SYSTEMS CORP. 1,573
COVIDIEN MFG DC BOULDER 1,558
ETHICON ENDO-SURGERY, INC. 1,323

Event Locations

29,623 (44.6%)
I 18,879 (28.4%)
NOT APPLICABLE 10,533 (15.9%)
OTHER 5,467 (8.2%)
HOSPITAL 1,580 (2.4%)
NO INFORMATION 256 (0.4%)
AMBULATORY SURGICAL FACILITY 16 (0.0%)
UNKNOWN 11 (0.0%)
INVALID DATA 7 (0.0%)
OUTPATIENT DIAGNOSTIC FACILITY 3 (0.0%)
HOME 2 (0.0%)
OUTPATIENT TREATMENT FACILITY 2 (0.0%)

Compare ETHICON ENDO-SURGERY, LLC. vs ETHICON ENDO-SURGERY, INC. (CINCINNATI) →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Instrument, Ultrasonic Surgical, 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 (66,379 here).

System, Balloon, Intra-Aortic And Control 64,419 Prosthesis 69,763 System 70,468 Colonoscope And Accessories, Flexible/Rigid 62,094

Similar death-typed counts

Nearest other device types by death-typed report count (81 here), distinct from the volume row.

Tubing, Pump, Cardiopulmonary Bypass 81 Apparatus, Autotransfusion 82 Device, Monitoring, Intracranial Pressure 82 Monitor, Apnea, Facility Use 82

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

Disclaimer: MAUDE figures for Instrument, Ultrasonic Surgical 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 Instrument, Ultrasonic Surgical; 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.