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2026 data FDA MAUDE openFDA FDA Class II

Electrocautery, Gynecologic (And 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 §884.4120 (Obstetrics/Gynecology panel).

Browse devices → Device safety hub

FDA MAUDE casebook

openFDA event book Electrocautery, Gynecologic LIGHT-BOOK · MAUDE

#744 of 1000 · 777 reports · 1992–2026

  • BOOK 777 reports
  • RANK #744 of 1000
  • DEATH 0 death-typed
  • INJ 58 injury-typed
  • MALF 711 malfunction
  • SPAN 1992–2026
  • PEAK 2019: 127
  • PHOTO Cleanser

Nearest event-volume peer: Cleanser, Denture, Over The Counter (1 report gap)

Electrocautery, Gynecologic (And Accessories) sits #744 of 1000 among tracked device types with 777 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

Electrocautery, Gynecologic carries 91.5% MALFUNCTION-coded reports, 26.7pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.0% corpus 1.5% · below corpus mean (-1.5 pp)
  • INJ 7.5% corpus 30.3% · below corpus mean (-22.8 pp)
  • MALF 91.5% corpus 64.8% · above corpus mean (+26.7 pp)

Lead product-problem code Electrical /Electronic Property Problem is 15% of coded problems · Lead manufacturer AESCULAP AG accounts for 29% of manufacturer-tagged reports · Top event location is 58% of location-tagged rows .

Electrocautery, Gynecologic in the event-volume neighbourhood

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

reports

What this shows Electrocautery, Gynecologic (And Accessories) carries 777 MAUDE reports, ranked #744 of 1000.

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

Event Types

Malfunction 711 (91.5%)
Injury 58 (7.5%)
Other 6 (0.8%)
2 (0.3%)

Patient Outcomes

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

Other 466 (57.6%)
244 (30.2%)
Required Intervention 58 (7.2%)
R 16 (2.0%)
O 12 (1.5%)
Hospitalization 4 (0.5%)
Disability 3 (0.4%)
H 2 (0.2%)
Death 2 (0.2%)
C 1 (0.1%)
D 1 (0.1%)

Top Product Problems

Electrical /Electronic Property Problem 96
Break 83
Output Problem 66
Failure to Cut 50
Therapeutic or Diagnostic Output Failure 46
Mechanical Problem 36
Device Operates Differently Than Expected 33
Melted 32
Detachment of Device or Device Component 25
Defective Component 23
Adverse Event Without Identified Device or Use Problem 19
Nonstandard Device 19
Sparking 19
Material Fragmentation 18
Power Problem 18
Insufficient Device Problem Information 17
Energy Output Problem 15
Defective Device 14
Electrical Power Problem 14
Loss of Power 13

Yearly Trend

92
1992: 3
94
1994: 1
97
1997: 2
99
1999: 1
00
2000: 1
01
2001: 2
02
2002: 3
03
2003: 3
04
2004: 6
05
2005: 2
08
2008: 1
09
2009: 1
10
2010: 1
11
2011: 2
13
2013: 6
14
2014: 1
15
2015: 27
16
2016: 56
17
2017: 33
18
2018: 30
19
2019: 127
20
2020: 102
21
2021: 100
22
2022: 104
23
2023: 61
24
2024: 44
25
2025: 41
26
2026: 16

Reports in 2025 (41) held close to the prior two-year average of 53.

Related Entities for Electrocautery, Gynecologic (And Accessories)

Top Manufacturers

AESCULAP AG 24
ETHICON ENDO-SURGERY, LLC 23
COVIDIEN MFG DC BOULDER 20
TELEFLEX MEDICAL 10
COVIDIEN 5

Event Locations

450 (57.9%)
I 240 (30.9%)
HOSPITAL 46 (5.9%)
NO INFORMATION 33 (4.2%)
AMBULATORY SURGICAL FACILITY 4 (0.5%)
UNKNOWN 2 (0.3%)
INVALID DATA 1 (0.1%)
OUTPATIENT TREATMENT FACILITY 1 (0.1%)

Compare AESCULAP AG vs ETHICON ENDO-SURGERY, LLC →

Nationwide devices with a comparable report-volume footprint

Electrocautery, Gynecologic carries zero death-typed MAUDE reports, so the peer set below compares report volume only; both axes are floored at ≥100 reports so the neighborhood stays in the advertised mass.

Similar report volume

Nearest other device types by FDA MAUDE report count (777 here).

Cleanser, Denture, Over The Counter 776 Computer 778 Appliance 779 Gown, Surgical 780

Similar death-typed counts

Nearest other device types by death-typed report count (0 here), distinct from the volume row.

Aberrometer, Ophthalmic 0 Accessories, Arthroscopic 0 Accessories, Cleaning Brushes, For Endoscope 0 Accessories, Implant, Dental, Endosseous 0

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

Disclaimer: MAUDE figures for Electrocautery, Gynecologic 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 Electrocautery, Gynecologic; 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.