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2026 data FDA MAUDE openFDA FDA Class III

Device, Thermal Ablation, Endometrial

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 Device, Thermal Ablation, Endometrial LIGHT-BOOK · MAUDE

#282 of 1000 · 6,312 reports · 1997–2026

  • BOOK 6,312 reports
  • RANK #282 of 1000
  • DEATH 22 death-typed
  • INJ 4,208 injury-typed
  • MALF 1,943 malfunction
  • SPAN 1997–2026
  • PEAK 2009: 792
  • PHOTO System

Nearest event-volume peer: System, Blood Culturing (42 report gap)

Device, Thermal Ablation, Endometrial sits #282 of 1000 among tracked device types with 6,312 MAUDE reports spanning 1997–2026. 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

Device, Thermal Ablation, Endometrial carries 66.7% INJURY-coded reports, 36.4pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.3% corpus 1.5% · below corpus mean (-1.2 pp)
  • INJ 66.7% corpus 30.3% · above corpus mean (+36.4 pp)
  • MALF 30.8% corpus 64.8% · below corpus mean (-34.0 pp)

Lead product-problem code Adverse Event Without Identified Device or Use Problem is 34% of coded problems · Lead manufacturer HOLOGIC, INC accounts for 34% of manufacturer-tagged reports · Top event location is 62% of location-tagged rows .

Device, Thermal Ablation, Endometrial in the event-volume neighbourhood

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

reports

What this shows Device, Thermal Ablation, Endometrial carries 6,312 MAUDE reports, ranked #282 of 1000.

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

Event Types

Injury 4,208 (66.7%)
Malfunction 1,943 (30.8%)
Other 87 (1.4%)
52 (0.8%)
Death 22 (0.3%)

Patient Outcomes

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

Other 2,191 (28.1%)
2,001 (25.6%)
Hospitalization 1,155 (14.8%)
R 975 (12.5%)
Required Intervention 881 (11.3%)
O 271 (3.5%)
L 110 (1.4%)
H 82 (1.1%)
S 58 (0.7%)
Life Threatening 39 (0.5%)
Death 20 (0.3%)
Disability 20 (0.3%)
Congenital Anomaly 2 (0.0%)
D 1 (0.0%)

Top Product Problems

Adverse Event Without Identified Device or Use Problem 1,832
Unknown (for use when the device problem is not known) 559
Insufficient Device Problem Information 459
Fluid/Blood Leak 447
Leak/Splash 280
Device Handling Problem 275
Device Operates Differently Than Expected 243
Material Puncture/Hole 226
Device Displays Incorrect Message 180
Other (for use when an appropriate device code cannot be identified) 125
Use of Device Problem 122
Replace 104
Balloon leak(s) 98
Loss of Power 78
Device Issue 77
Appropriate Device Problem Term/Code Not Available 64
Material Deformation 64
Device Inoperable 57
Break 54
Alarm, audible 53

Yearly Trend

97
1997: 1
98
1998: 2
99
1999: 6
02
2002: 9
03
2003: 41
04
2004: 46
05
2005: 91
06
2006: 142
07
2007: 180
08
2008: 290
09
2009: 792
10
2010: 389
11
2011: 433
12
2012: 408
13
2013: 368
14
2014: 309
15
2015: 318
16
2016: 296
17
2017: 292
18
2018: 262
19
2019: 249
20
2020: 197
21
2021: 229
22
2022: 179
23
2023: 213
24
2024: 213
25
2025: 251
26
2026: 106

Reports in 2025 (251) held close to the prior two-year average of 213.

Related Entities for Device, Thermal Ablation, Endometrial

Top Manufacturers

HOLOGIC, INC 1,104
HOLOGIC, INC. 883
BOSTON SCIENTIFIC CORPORATION 517
BOSTON SCIENTIFIC - MARLBOROUGH 450
BOSTON SCIENTIFIC - SPENCER 146
ETHICON, INC. 133

Event Locations

3,911 (62.0%)
I 1,312 (20.8%)
HOSPITAL 786 (12.5%)
NO INFORMATION 175 (2.8%)
AMBULATORY SURGICAL FACILITY 48 (0.8%)
OTHER 28 (0.4%)
UNKNOWN 24 (0.4%)
AMBULATORY HEALTH CARE FACILITY 8 (0.1%)
OUTPATIENT TREATMENT FACILITY 8 (0.1%)
CLINIC - WALK IN, OTHER 4 (0.1%)
HOME 3 (0.0%)
AMBULATORY SURGICAL CENTER 2 (0.0%)
INVALID DATA 2 (0.0%)
NOT APPLICABLE 1 (0.0%)

Compare HOLOGIC, INC vs HOLOGIC, INC. →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Device, Thermal Ablation, Endometrial: 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 (6,312 here).

System, Blood Culturing 6,354 Catheter 6,232 Prosthesis, Intervertebral Disc 6,148 System, Imaging, Pulsed Echo, Ultrasonic 6,516

Similar death-typed counts

Nearest other device types by death-typed report count (22 here), distinct from the volume row.

Accessories, Cleaning, For Endoscope 22 Charger, Pacemaker 22 Endoscopic Access Overtube 22 Saline, Vascular Access Flush 22

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

Disclaimer: MAUDE figures for Device, Thermal Ablation, Endometrial 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 Device, Thermal Ablation, Endometrial; 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.