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2026 data FDA MAUDE openFDA

Generator, Lesion, Radiofrequency

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 Generator, Lesion, Radiofrequency LIGHT-BOOK · MAUDE

#509 of 1000 · 1,784 reports · 1992–2026

  • BOOK 1,784 reports
  • RANK #509 of 1000
  • DEATH 4 death-typed
  • INJ 748 injury-typed
  • MALF 960 malfunction
  • SPAN 1992–2026
  • PEAK 2019: 195
  • PHOTO Operating Room Access…

Nearest event-volume peer: Operating Room Accessories Table Tray (3 report gap)

Generator, Lesion, Radiofrequency sits #509 of 1000 among tracked device types with 1,784 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 →

Event-type mix vs corpus

Shares of FDA event_type codes on this device type, compared with the mean across 1,000 device types that have ≥100 MAUDE reports. Codes are report labels, not adjudicated causation.

  • DEATH 0.2% corpus 1.5% · below corpus mean (-1.3 pp)
  • INJ 41.9% corpus 30.4% · above corpus mean (+11.5 pp)
  • MALF 53.8% corpus 64.5% · below corpus mean (-10.7 pp)

Lead product-problem code Adverse Event Without Identified Device or Use Problem is 17% of coded problems · Lead manufacturer ST. JUDE MEDICAL, INC. accounts for 45% of manufacturer-tagged reports · Top event location is 49% of location-tagged rows .

Generator, Lesion, Radiofrequency in the event-volume neighbourhood

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

reports

What this shows Generator, Lesion, Radiofrequency carries 1,784 MAUDE reports, ranked #509 of 1000.

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

Event Types

Malfunction 960 (53.8%)
Injury 748 (41.9%)
Other 60 (3.4%)
12 (0.7%)
Death 4 (0.2%)

Patient Outcomes

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

951 (52.7%)
Other 693 (38.4%)
Required Intervention 100 (5.5%)
Hospitalization 21 (1.2%)
R 13 (0.7%)
Life Threatening 11 (0.6%)
L 4 (0.2%)
Death 4 (0.2%)
O 3 (0.2%)
Disability 3 (0.2%)

Top Product Problems

Adverse Event Without Identified Device or Use Problem 174
Insufficient Heating 125
Temperature Problem 103
Output Problem 81
Fracture 76
Communication or Transmission Problem 67
Failure to Power Up 46
Thermal Decomposition of Device 42
Unexpected Shutdown 36
Smoking 32
Device Operates Differently Than Expected 31
Failure to Deliver Energy 25
Insufficient Information 24
Material Deformation 24
Impedance Problem 22
High impedance 21
Noise, Audible 19
Overheating of Device 18
Device Emits Odor 15
Connection Problem 14

Yearly Trend

92
1992: 2
94
1994: 1
95
1995: 6
96
1996: 6
97
1997: 10
98
1998: 7
99
1999: 3
00
2000: 11
01
2001: 4
02
2002: 13
03
2003: 6
04
2004: 44
05
2005: 76
06
2006: 7
07
2007: 10
08
2008: 10
09
2009: 12
10
2010: 69
11
2011: 89
12
2012: 77
13
2013: 119
14
2014: 64
15
2015: 67
16
2016: 51
17
2017: 83
18
2018: 156
19
2019: 195
20
2020: 138
21
2021: 154
22
2022: 84
23
2023: 54
24
2024: 63
25
2025: 88
26
2026: 5

Related Entities for Generator, Lesion, Radiofrequency

Top Manufacturers

ST. JUDE MEDICAL, INC. 393
STRYKER INSTRUMENTS KALAMAZOO 146
STRYKER INSTRUMENTS-KALAMAZOO 145
ST. JUDE MEDICAL 113
STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP 84

Event Locations

880 (49.3%)
I 795 (44.6%)
HOSPITAL 73 (4.1%)
OUTPATIENT TREATMENT FACILITY 12 (0.7%)
NO INFORMATION 8 (0.4%)
AMBULATORY SURGICAL FACILITY 4 (0.2%)
INVALID DATA 4 (0.2%)
OTHER 4 (0.2%)
UNKNOWN 3 (0.2%)
OUTPATIENT DIAGNOSTIC FACILITY 1 (0.1%)

Compare ST. JUDE MEDICAL, INC. vs STRYKER INSTRUMENTS KALAMAZOO →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Generator, Lesion, Radiofrequency, both floored at ≥100 reports so the neighborhoods stay in the advertised mass.

Similar report volume

Nearest other device types by FDA MAUDE report count (1,784 here).

Operating Room Accessories Table Tray 1,781 Prosthesis, Elbow, Hemi-, Radial, Polymer 1,772 Catheter, Septostomy 1,797 Set, Blood Transfusion 1,807

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 4

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

Disclaimer: MAUDE figures for Generator, Lesion, Radiofrequency 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 Generator, Lesion, Radiofrequency; 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.