2026 data FDA MAUDE openFDA FDA Class II

Electrode, Electrosurgical

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 Electrode, Electrosurgical LIGHT-BOOK · MAUDE

#735 of 1000 · 798 reports · 1992–2026

  • BOOK 798 reports
  • RANK #735 of 1000
  • DEATH 19 death-typed
  • INJ 238 injury-typed
  • MALF 477 malfunction
  • SPAN 1992–2026
  • PEAK 2005: 111
  • PHOTO Enteroscope And Acces…

Nearest event-volume peer: Enteroscope And Accessories (2 report gap)

Electrode, Electrosurgical sits #735 of 1000 among tracked device types with 798 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 sit below the device-type norm

Electrode, Electrosurgical carries 59.8% MALFUNCTION-coded reports, 5.1pp below the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 2.4% corpus 1.5% · above corpus mean (+0.9 pp)
  • INJ 29.8% corpus 30.3% · near corpus mean (-0.5 pp)
  • MALF 59.8% corpus 64.8% · below corpus mean (-5.1 pp)

Lead product-problem code Unknown (for use when the device problem is not known) is 18% of coded problems · Lead manufacturer ETHICON, INC. accounts for 25% of manufacturer-tagged reports · Top event location is 67% of location-tagged rows .

Electrode, Electrosurgical in the event-volume neighbourhood

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

reports

What this shows Electrode, Electrosurgical carries 798 MAUDE reports, ranked #735 of 1000.

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

Event Types

Malfunction 477 (59.8%)
Injury 238 (29.8%)
Other 52 (6.5%)
Death 19 (2.4%)
12 (1.5%)

Patient Outcomes

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

464 (55.0%)
Other 134 (15.9%)
Required Intervention 133 (15.8%)
Hospitalization 37 (4.4%)
R 30 (3.6%)
Death 19 (2.3%)
L 8 (0.9%)
Life Threatening 7 (0.8%)
O 4 (0.5%)
Disability 3 (0.4%)
Invalid Data 2 (0.2%)
H 1 (0.1%)
S 1 (0.1%)

Top Product Problems

Unknown (for use when the device problem is not known) 127
Replace 75
Melted 62
Break 60
Other (for use when an appropriate device code cannot be identified) 53
Tip breakage 46
Peeled/Delaminated 34
Thermal Decomposition of Device 30
Detachment Of Device Component 28
Sparking 21
Fire 18
Insulation, detached 18
Biofilm coating in Device 17
Insulation failure 17
Device, or device fragments remain in patient 16
Device Issue 14
Insulation, hole(s) in 14
Use of Device Problem 14
Component Falling 13
Crack 13

Yearly Trend

92
1992: 4
93
1993: 6
94
1994: 3
95
1995: 1
96
1996: 3
97
1997: 9
98
1998: 33
99
1999: 68
00
2000: 56
01
2001: 32
02
2002: 26
03
2003: 37
04
2004: 59
05
2005: 111
06
2006: 77
07
2007: 29
08
2008: 37
09
2009: 62
10
2010: 14
11
2011: 5
12
2012: 7
13
2013: 5
14
2014: 7
15
2015: 13
16
2016: 5
17
2017: 7
18
2018: 10
19
2019: 17
20
2020: 12
21
2021: 5
22
2022: 8
23
2023: 9
24
2024: 3
25
2025: 6
26
2026: 12

Reports in 2025 (6) held close to the prior two-year average of 6.

Related Entities for Electrode, Electrosurgical

Event Locations

537 (67.3%)
HOSPITAL 192 (24.1%)
I 43 (5.4%)
AMBULATORY SURGICAL FACILITY 9 (1.1%)
INVALID DATA 7 (0.9%)
NO INFORMATION 5 (0.6%)
UNKNOWN 5 (0.6%)

Compare ETHICON, INC. vs BOSTON SCIENTIFIC →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Electrode, 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 (798 here).

Similar death-typed counts

Nearest other device types by death-typed report count (19 here), distinct from the volume row.

Disclaimer: MAUDE figures for Electrode, 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 Electrode, 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.