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2026 data FDA MAUDE openFDA FDA Class II

Electrode, Electrosurgical, Active, Urological

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 §876.4300 (Gastroenterology, Urology panel).

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FDA MAUDE casebook

openFDA event book Electrode LIGHT-BOOK · MAUDE

#459 of 1000 · 2,372 reports · 1992–2026

  • BOOK 2,372 reports
  • RANK #459 of 1000
  • DEATH 4 death-typed
  • INJ 459 injury-typed
  • MALF 1,867 malfunction
  • SPAN 1992–2026
  • PEAK 2025: 403
  • PHOTO Intervertebral Fusion…

Nearest event-volume peer: Intervertebral Fusion Device With Integrated Fixation, Cervical (3 report gap)

Electrode, Electrosurgical, Active, Urological sits #459 of 1000 among tracked device types with 2,372 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

Electrode carries 78.7% MALFUNCTION-coded reports, 13.9pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.2% corpus 1.5% · below corpus mean (-1.3 pp)
  • INJ 19.4% corpus 30.3% · below corpus mean (-10.9 pp)
  • MALF 78.7% corpus 64.8% · above corpus mean (+13.9 pp)

Lead product-problem code Break is 44% of coded problems · Lead manufacturer OLYMPUS WINTER & IBE GMBH accounts for 60% of manufacturer-tagged reports · Top event location is 66% of location-tagged rows .

Electrode in the event-volume neighbourhood

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

reports

What this shows Electrode, Electrosurgical, Active, Urological carries 2,372 MAUDE reports, ranked #459 of 1000.

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

Event Types

Malfunction 1,867 (78.7%)
Injury 459 (19.4%)
Other 36 (1.5%)
6 (0.3%)
Death 4 (0.2%)

Patient Outcomes

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

1,720 (71.9%)
Other 309 (12.9%)
Required Intervention 261 (10.9%)
Hospitalization 27 (1.1%)
R 23 (1.0%)
Disability 11 (0.5%)
O 9 (0.4%)
H 8 (0.3%)
S 6 (0.3%)
Death 6 (0.3%)
L 5 (0.2%)
Life Threatening 5 (0.2%)
D 1 (0.0%)
Congenital Anomaly 1 (0.0%)

Top Product Problems

Break 1,169
Detachment of Device or Device Component 249
Material Fragmentation 166
Fracture 144
Sparking 125
Mechanical Problem 114
Melted 101
Material Twisted/Bent 84
Detachment Of Device Component 82
Material Separation 60
Thermal Decomposition of Device 60
Adverse Event Without Identified Device or Use Problem 55
Material Deformation 45
Overheating of Device 37
Component Falling 36
Insufficient Device Problem Information 32
Arcing 29
Replace 28
Crack 25
Fire 25

Yearly Trend

92
1992: 2
94
1994: 1
95
1995: 1
96
1996: 9
97
1997: 7
98
1998: 8
99
1999: 13
00
2000: 23
01
2001: 12
02
2002: 16
03
2003: 9
04
2004: 9
05
2005: 8
06
2006: 11
07
2007: 6
08
2008: 13
09
2009: 9
10
2010: 25
11
2011: 33
12
2012: 30
13
2013: 48
14
2014: 52
15
2015: 82
16
2016: 69
17
2017: 121
18
2018: 70
19
2019: 61
20
2020: 99
21
2021: 102
22
2022: 147
23
2023: 329
24
2024: 310
25
2025: 403
26
2026: 234

Reports in 2025 (403) held close to the prior two-year average of 320.

Related Entities for Electrode, Electrosurgical, Active, Urological

Top Manufacturers

OLYMPUS WINTER & IBE GMBH 885
KARL STORZ SE & CO. KG 476
GYRUS ACMI, INC 57
GYRUS ACMI, INC. 55

Event Locations

1,555 (65.6%)
I 472 (19.9%)
HOSPITAL 299 (12.6%)
NO INFORMATION 28 (1.2%)
AMBULATORY SURGICAL FACILITY 8 (0.3%)
INVALID DATA 4 (0.2%)
OUTPATIENT TREATMENT FACILITY 4 (0.2%)
OTHER 1 (0.0%)
UNKNOWN 1 (0.0%)

Compare OLYMPUS WINTER & IBE GMBH vs KARL STORZ SE & CO. KG →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Electrode: 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 (2,372 here).

Intervertebral Fusion Device With Integrate… 2,375 Stimulator, Autonomic Nerve, Implanted 2,367 Catheter, Peritoneal, Long-Term Indwelling 2,355 Transducer, Pressure, Catheter Tip 2,389

Similar death-typed counts

Nearest other device types by death-typed report count (4 here), distinct from the volume row.

Catheter, Urethral 4 Disinfectant, Medical Devices 4 Drill, Surgical, Ent Including Handpiece 4 Electrode, Ion Specific, Potassium 4

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

Disclaimer: MAUDE figures for Electrode 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; 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.