2026 data FDA MAUDE openFDA FDA Class II

Electrosurgical, Cutting & Coagulation & Accessories

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 §878.4400 (General, Plastic Surgery panel).

FDA MAUDE casebook

openFDA event book Electrosurgical HEAVY-BOOK · MAUDE

#35 of 1000 · 117,697 reports · 1992–2026

  • BOOK 117,697 reports
  • RANK #35 of 1000
  • DEATH 467 death-typed
  • INJ 19,658 injury-typed
  • MALF 94,288 malfunction
  • SPAN 1992–2026
  • PEAK 2024: 7,898
  • PHOTO Prosthesis

Nearest event-volume peer: Prosthesis, Breast, Inflatable, Internal, Saline (79 report gap)

Electrosurgical, Cutting & Coagulation & Accessories sits #35 of 1000 among tracked device types with 117,697 MAUDE reports spanning 1992–2026. 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

Electrosurgical carries 80.1% MALFUNCTION-coded reports, 15.3pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.4% corpus 1.5% · below corpus mean (-1.1 pp)
  • INJ 16.7% corpus 30.3% · below corpus mean (-13.6 pp)
  • MALF 80.1% corpus 64.8% · above corpus mean (+15.3 pp)

Lead product-problem code Break is 20% of coded problems · Lead manufacturer COVIDIEN MFG DC BOULDER accounts for 24% of manufacturer-tagged reports · Top event location is 56% of location-tagged rows .

Electrosurgical in the event-volume neighbourhood

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

reports

What this shows Electrosurgical, Cutting & Coagulation & Accessories carries 117,697 MAUDE reports, ranked #35 of 1000.

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

Event Types

Malfunction 94,288 (80.1%)
Injury 19,658 (16.7%)
Other 2,642 (2.2%)
641 (0.5%)
Death 467 (0.4%)
No answer provided 1 (0.0%)

Patient Outcomes

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

91,697 (76.6%)
Other 12,645 (10.6%)
Required Intervention 9,388 (7.8%)
R 1,930 (1.6%)
Hospitalization 1,723 (1.4%)
O 692 (0.6%)
Death 446 (0.4%)
H 337 (0.3%)
Life Threatening 308 (0.3%)
Disability 260 (0.2%)
L 171 (0.1%)
S 103 (0.1%)
D 33 (0.0%)
Congenital Anomaly 17 (0.0%)
Invalid Data 8 (0.0%)
Not Applicable 1 (0.0%)

Top Product Problems

Break 16,494
Adverse Event Without Identified Device or Use Problem 7,716
Difficult to Open or Close 5,752
Device Operates Differently Than Expected 4,568
Detachment of Device or Device Component 4,432
Energy Output Problem 4,236
Detachment Of Device Component 4,189
Peeled/Delaminated 3,509
Device Displays Incorrect Message 3,432
Insufficient Device Problem Information 3,331
Replace 3,281
Electrical /Electronic Property Problem 3,138
Unknown (for use when the device problem is not known) 2,749
Self-Activation or Keying 2,708
Fire 2,104
Sparking 2,008
Sticking 1,806
Output Problem 1,800
Melted 1,780
Device Inoperable 1,750

Yearly Trend

92
1992: 19
93
1993: 28
94
1994: 94
95
1995: 103
96
1996: 355
97
1997: 708
98
1998: 551
99
1999: 569
00
2000: 603
01
2001: 603
02
2002: 731
03
2003: 1,046
04
2004: 1,208
05
2005: 1,130
06
2006: 1,843
07
2007: 2,795
08
2008: 2,556
09
2009: 3,591
10
2010: 3,377
11
2011: 4,463
12
2012: 5,216
13
2013: 4,897
14
2014: 4,908
15
2015: 4,936
16
2016: 5,616
17
2017: 6,073
18
2018: 6,545
19
2019: 7,067
20
2020: 6,491
21
2021: 6,354
22
2022: 6,103
23
2023: 7,176
24
2024: 7,898
25
2025: 7,696
26
2026: 4,348

Reports in 2025 (7,696) held close to the prior two-year average of 7,537.

Related Entities for Electrosurgical, Cutting & Coagulation & Accessories

Event Locations

65,347 (55.5%)
I 36,736 (31.2%)
HOSPITAL 9,153 (7.8%)
OTHER 2,757 (2.3%)
NOT APPLICABLE 1,514 (1.3%)
NO INFORMATION 1,119 (1.0%)
AMBULATORY SURGICAL FACILITY 380 (0.3%)
INVALID DATA 294 (0.2%)
OUTPATIENT TREATMENT FACILITY 218 (0.2%)
UNKNOWN 113 (0.1%)
OUTPATIENT DIAGNOSTIC FACILITY 42 (0.0%)
HOME 16 (0.0%)
AMBULATORY SURGICAL CENTER 3 (0.0%)
OPERATING ROOM 3 (0.0%)
OUTPATIENT CLINIC/SURGERY 2 (0.0%)

Compare COVIDIEN MFG DC BOULDER vs OLYMPUS MEDICAL SYSTEMS CORP. →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Electrosurgical: 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 (117,697 here).

Similar death-typed counts

Nearest other device types by death-typed report count (467 here), distinct from the volume row.

Disclaimer: MAUDE figures for Electrosurgical 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 Electrosurgical; 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.