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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

#58 of 1000 · 68,052 reports · 1995–2026

  • BOOK 68,052 reports
  • RANK #58 of 1000
  • DEATH 81 death-typed
  • INJ 3,065 injury-typed
  • MALF 64,582 malfunction
  • SPAN 1995–2026
  • PEAK 2014: 4,260
  • PHOTO System

Nearest event-volume peer: System, Balloon, Intra-Aortic And Control (162 report gap)

Instrument, Ultrasonic Surgical sits #58 of 1000 among tracked device types with 68,052 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 →

Malfunction reports run above the device-type norm

Instrument, Ultrasonic Surgical carries 94.9% MALFUNCTION-coded reports, 30.1pp 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 4.5% corpus 30.3% · below corpus mean (-25.8 pp)
  • MALF 94.9% corpus 64.8% · above corpus mean (+30.1 pp)

Lead product-problem code Break is 19% of coded problems · Lead manufacturer ETHICON ENDO-SURGERY, LLC. accounts for 69% of manufacturer-tagged reports · Top event location is 46% 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 68,052 MAUDE reports, ranked #58 of 1000.

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

Event Types

Malfunction 64,582 (94.9%)
Injury 3,065 (4.5%)
260 (0.4%)
Death 81 (0.1%)
Other 63 (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.

60,747 (89.2%)
Other 5,247 (7.7%)
Required Intervention 1,621 (2.4%)
R 142 (0.2%)
Hospitalization 117 (0.2%)
Death 84 (0.1%)
Disability 56 (0.1%)
O 46 (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

Break 14,000
Replace 9,075
Device Displays Incorrect Message 7,360
Material Separation 7,351
Failure to Read Input Signal 5,527
Detachment Of Device Component 4,739
Detachment of Device or Device Component 4,580
Device Issue 2,707
Component Falling 2,698
Device Inoperable 2,126
Device Operates Differently Than Expected 1,824
Difficult or Delayed Activation 1,661
Sticking 1,660
Noise 1,372
Component(s), broken 1,140
Material Integrity Problem 1,055
Melted 961
Adverse Event Without Identified Device or Use Problem 856
Overheating of Device 830
Tip breakage 830

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: 1,678
09
2009: 3,324
10
2010: 1,239
11
2011: 1,053
12
2012: 1,491
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: 2,349

Reports in 2025 (3,907) held close to the prior two-year average of 4,116.

Related Entities for Instrument, Ultrasonic Surgical

Top Manufacturers

ETHICON ENDO-SURGERY, LLC. 38,769
ETHICON ENDO-SURGERY, INC. (CINCINNATI) 3,030
ETHICON ENDO-SURGERY, LLC 2,858
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. 1,330
AOMORI OLYMPUS CO., LTD. 982

Event Locations

31,286 (46.0%)
I 18,879 (27.7%)
NOT APPLICABLE 10,533 (15.5%)
OTHER 5,467 (8.0%)
HOSPITAL 1,590 (2.3%)
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 a comparable volume-and-death footprint

Two openFDA-derived peer sets for Instrument, Ultrasonic Surgical: 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 (68,052 here).

System, Balloon, Intra-Aortic And Control 67,890 Prosthesis 70,458 System 71,804 Set 72,142

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 Unit, Electrosurgical, Endoscopic 81 Apparatus, Autotransfusion 82 Device, Monitoring, Intracranial Pressure 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.