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2026 data FDA MAUDE openFDA

Probe, Radiofrequency Lesion

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 Probe, Radiofrequency Lesion LIGHT-BOOK · MAUDE

#696 of 1000 · 844 reports · 1996–2026

  • BOOK 844 reports
  • RANK #696 of 1000
  • DEATH 6 death-typed
  • INJ 294 injury-typed
  • MALF 526 malfunction
  • SPAN 1996–2026
  • PEAK 2017: 150
  • PHOTO Device

Nearest event-volume peer: Device, Endoscopic Suturing (1 report gap)

Probe, Radiofrequency Lesion sits #696 of 1000 among tracked device types with 844 MAUDE reports spanning 1996–2026. 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 0.7% corpus 1.5% · below corpus mean (-0.8 pp)
  • INJ 34.8% corpus 30.4% · above corpus mean (+4.4 pp)
  • MALF 62.3% corpus 64.5% · below corpus mean (-2.2 pp)

Lead product-problem code Adverse Event Without Identified Device or Use Problem is 27% of coded problems · Lead manufacturer BOSTON SCIENTIFIC NEUROMODULATION accounts for 49% of manufacturer-tagged reports · Top event location I is 56% of location-tagged rows .

Probe, Radiofrequency Lesion in the event-volume neighbourhood

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

reports

What this shows Probe, Radiofrequency Lesion carries 844 MAUDE reports, ranked #696 of 1000.

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

Event Types

Malfunction 526 (62.3%)
Injury 294 (34.8%)
Other 15 (1.8%)
Death 6 (0.7%)
3 (0.4%)

Patient Outcomes

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

513 (57.6%)
Other 153 (17.2%)
Required Intervention 131 (14.7%)
Hospitalization 29 (3.3%)
R 22 (2.5%)
O 9 (1.0%)
Disability 8 (0.9%)
H 7 (0.8%)
Death 6 (0.7%)
S 5 (0.6%)
Life Threatening 4 (0.4%)
L 2 (0.2%)
D 1 (0.1%)

Top Product Problems

Adverse Event Without Identified Device or Use Problem 197
Break 91
Material Separation 73
Material Discolored 53
Device Misassembled During Manufacturing /Shipping 41
Insufficient Heating 40
Defective Device 37
Material Fragmentation 33
Contamination /Decontamination Problem 30
Temperature Problem 25
Material Integrity Problem 17
Material Erosion 15
Fracture 13
Leak/Splash 13
Use of Device Problem 13
Detachment of Device or Device Component 9
Peeled/Delaminated 8
No Apparent Adverse Event 7
Nonstandard Device 7
Fluid/Blood Leak 6

Yearly Trend

96
1996: 2
97
1997: 10
98
1998: 7
99
1999: 4
06
2006: 2
07
2007: 1
08
2008: 4
09
2009: 10
10
2010: 8
11
2011: 5
12
2012: 14
13
2013: 25
14
2014: 20
15
2015: 23
16
2016: 16
17
2017: 150
18
2018: 147
19
2019: 93
20
2020: 31
21
2021: 30
22
2022: 46
23
2023: 35
24
2024: 45
25
2025: 98
26
2026: 18

Related Entities for Probe, Radiofrequency Lesion

Top Manufacturers

BOSTON SCIENTIFIC NEUROMODULATION 130
ST. JUDE MEDICAL, INC. 51
AVANOS MEDICAL INC. 39
STRYKER INSTRUMENTS-KALAMAZOO 29
BOSTON SCIENTIFIC NEUROMODULATION CORPORATION 15

Event Locations

I 474 (56.2%)
332 (39.3%)
HOSPITAL 20 (2.4%)
AMBULATORY SURGICAL FACILITY 5 (0.6%)
OUTPATIENT TREATMENT FACILITY 5 (0.6%)
NO INFORMATION 2 (0.2%)
OTHER 2 (0.2%)
UNKNOWN 2 (0.2%)
INVALID DATA 1 (0.1%)
NOT APPLICABLE 1 (0.1%)

Compare BOSTON SCIENTIFIC NEUROMODULATION vs ST. JUDE MEDICAL, INC. →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Probe, Radiofrequency Lesion, 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 (844 here).

Device, Endoscopic Suturing 843 Heat-Exchanger, Cardiopulmonary Bypass 845 Digital Breast Tomosynthesis 846 Plate, Cranioplasty, Preformed, Alterable 842

Similar death-typed counts

Nearest other device types by death-typed report count (6 here), distinct from the volume row.

Applicator, Absorbent Tipped, Non-Sterile 6 Cable, Electrode 6 Catheter, Straight 6 Device, Percutaneous Retrieval 6

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

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