PlainHospital
2026 data FDA MAUDE openFDA FDA Class II

System, Ablation, Microwave 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 §878.4400 (General, Plastic Surgery panel).

Browse devices → Device safety hub

FDA MAUDE casebook

openFDA event book System, Ablation, Microwave And Accessories LIGHT-BOOK · MAUDE

#527 of 1000 · 1,784 reports · 2002–2026

  • BOOK 1,784 reports
  • RANK #527 of 1000
  • DEATH 45 death-typed
  • INJ 711 injury-typed
  • MALF 1,020 malfunction
  • SPAN 2002–2026
  • PEAK 2017: 225
  • PHOTO Prosthesis

Nearest event-volume peer: Prosthesis, Elbow, Hemi-, Radial, Polymer (9 report gap)

System, Ablation, Microwave And Accessories sits #527 of 1000 among tracked device types with 1,784 MAUDE reports spanning 2002–2026. 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 →

Injury-coded reports run above the device-type norm

System, Ablation, Microwave And Accessories carries 39.9% INJURY-coded reports, 9.6pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 2.5% corpus 1.5% · above corpus mean (+1.0 pp)
  • INJ 39.9% corpus 30.3% · above corpus mean (+9.6 pp)
  • MALF 57.2% corpus 64.8% · below corpus mean (-7.7 pp)

Lead product-problem code Adverse Event Without Identified Device or Use Problem is 21% of coded problems · Lead manufacturer COVIDIEN LP accounts for 71% of manufacturer-tagged reports · Top event location I is 50% of location-tagged rows .

System, Ablation, Microwave And Accessories in the event-volume neighbourhood

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

reports

What this shows System, Ablation, Microwave And Accessories carries 1,784 MAUDE reports, ranked #527 of 1000.

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

Event Types

Malfunction 1,020 (57.2%)
Injury 711 (39.9%)
Death 45 (2.5%)
Other 5 (0.3%)
3 (0.2%)

Patient Outcomes

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

1,026 (54.3%)
Required Intervention 371 (19.6%)
Other 289 (15.3%)
R 55 (2.9%)
Hospitalization 43 (2.3%)
Death 39 (2.1%)
O 26 (1.4%)
H 15 (0.8%)
Life Threatening 9 (0.5%)
D 7 (0.4%)
L 4 (0.2%)
S 3 (0.2%)
Disability 2 (0.1%)
Congenital Anomaly 1 (0.1%)

Top Product Problems

Adverse Event Without Identified Device or Use Problem 397
Detachment of Device or Device Component 272
Temperature Problem 267
Break 200
Appropriate Device Problem Term/Code Not Available 140
Device Displays Incorrect Message 95
Detachment Of Device Component 92
Fracture 86
Bent 54
Insufficient Device Problem Information 54
Leak/Splash 30
Device Operates Differently Than Expected 27
No Flow 27
Device Alarm System 26
Crack 17
Energy Output Problem 16
Failure to Fire 16
Device Inoperable 15
Material Twisted/Bent 15
Use of Device Problem 14

Yearly Trend

02
2002: 2
03
2003: 4
04
2004: 2
05
2005: 3
06
2006: 3
07
2007: 18
08
2008: 15
09
2009: 7
10
2010: 28
11
2011: 26
12
2012: 9
13
2013: 16
14
2014: 27
15
2015: 92
16
2016: 176
17
2017: 225
18
2018: 102
19
2019: 123
20
2020: 128
21
2021: 217
22
2022: 142
23
2023: 106
24
2024: 141
25
2025: 113
26
2026: 59

Reports in 2025 (113) held close to the prior two-year average of 124.

Related Entities for System, Ablation, Microwave And Accessories

Top Manufacturers

COVIDIEN LP 144
COVIDIEN MFG DC BOULDER 60

Event Locations

I 897 (50.3%)
767 (43.0%)
HOSPITAL 74 (4.1%)
NO INFORMATION 44 (2.5%)
OTHER 2 (0.1%)

Compare COVIDIEN LP vs COVIDIEN MFG DC BOULDER →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for System, Ablation, Microwave And Accessories: 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 (1,784 here).

Prosthesis, Elbow, Hemi-, Radial, Polymer 1,793 Cannula, Manipulator/Injector, Uterine 1,772 Needle, Aspiration And Injection, Disposable 1,796 Cannula, Nasal, Oxygen 1,767

Similar death-typed counts

Nearest other device types by death-typed report count (45 here), distinct from the volume row.

Filler 45 Glue, Surgical, Arteries 45 Monitor, Physiological, Patient 45 Catheter, Peritoneal, Long-Term Indwelling 46

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

Disclaimer: MAUDE figures for System, Ablation, Microwave And Accessories 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 System, Ablation, Microwave And Accessories; 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.