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2026 data FDA MAUDE openFDA FDA Class II

Unit, Cautery, Thermal, Ac-Powered

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 §886.4115 (Ophthalmic panel).

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FDA MAUDE casebook

openFDA event book Unit, Cautery, Thermal, Ac-Powered LIGHT-BOOK · MAUDE

#696 of 1000 · 893 reports · 1992–2026

  • BOOK 893 reports
  • RANK #696 of 1000
  • DEATH 0 death-typed
  • INJ 42 injury-typed
  • MALF 845 malfunction
  • SPAN 1992–2026
  • PEAK 2025: 102
  • PHOTO Laparoscopic Contrace…

Nearest event-volume peer: Laparoscopic Contraceptive Tubal Occlusion Device (0 report gap)

Unit, Cautery, Thermal, Ac-Powered sits #696 of 1000 among tracked device types with 893 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

Unit, Cautery, Thermal, Ac-Powered carries 94.6% MALFUNCTION-coded reports, 29.8pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.0% corpus 1.5% · below corpus mean (-1.5 pp)
  • INJ 4.7% corpus 30.3% · below corpus mean (-25.6 pp)
  • MALF 94.6% corpus 64.8% · above corpus mean (+29.8 pp)

Lead product-problem code Failure to Deliver Energy is 29% of coded problems · Lead manufacturer MAQUET CARDIOVASCULAR LLC accounts for 65% of manufacturer-tagged reports · Top event location is 61% of location-tagged rows .

Unit, Cautery, Thermal, Ac-Powered in the event-volume neighbourhood

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

reports

What this shows Unit, Cautery, Thermal, Ac-Powered carries 893 MAUDE reports, ranked #696 of 1000.

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

Event Types

Malfunction 845 (94.6%)
Injury 42 (4.7%)
4 (0.4%)
Other 2 (0.2%)

Patient Outcomes

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

832 (93.9%)
Required Intervention 25 (2.8%)
Other 22 (2.5%)
Invalid Data 3 (0.3%)
R 2 (0.2%)
Hospitalization 2 (0.2%)

Top Product Problems

Failure to Deliver Energy 248
Electrical /Electronic Property Problem 159
Intermittent Continuity 81
Device Issue 57
Break 42
Intermittent Loss of Power 32
Device Stops Intermittently 29
Failure to Power Up 29
Device Operates Differently Than Expected 28
Loss of Power 28
Insufficient Device Problem Information 26
Power Problem 19
Component Missing 15
Crack 14
Device Inoperable 14
Detachment of Device or Device Component 9
Noise, Audible 9
Smoking 9
Connection Problem 8
Device Remains Activated 6

Yearly Trend

92
1992: 5
93
1993: 9
94
1994: 3
95
1995: 2
96
1996: 20
97
1997: 48
98
1998: 3
01
2001: 1
03
2003: 1
05
2005: 1
10
2010: 13
11
2011: 30
12
2012: 29
13
2013: 40
14
2014: 55
15
2015: 42
16
2016: 56
18
2018: 17
19
2019: 73
20
2020: 44
21
2021: 56
22
2022: 53
23
2023: 48
24
2024: 66
25
2025: 102
26
2026: 76

Reports rose to 102 in 2025, up from an average of 57 in the two years before - a recent-year increase, not a lifetime pattern.

Related Entities for Unit, Cautery, Thermal, Ac-Powered

Top Manufacturers

MAQUET CARDIOVASCULAR LLC 495
MAQUET CARDIOVASCULAR, LLC 149
MAQUET CV 100
MAQUET CARDIOVASCULAR, LLC. 14

Event Locations

546 (61.1%)
I 255 (28.6%)
HOSPITAL 63 (7.1%)
OUTPATIENT TREATMENT FACILITY 20 (2.2%)
INVALID DATA 4 (0.4%)
AMBULATORY SURGICAL FACILITY 2 (0.2%)
NO INFORMATION 1 (0.1%)
OUTPATIENT DIAGNOSTIC FACILITY 1 (0.1%)
UNKNOWN 1 (0.1%)

Compare MAQUET CARDIOVASCULAR LLC vs MAQUET CARDIOVASCULAR, LLC →

Nationwide devices with a comparable report-volume footprint

Unit, Cautery, Thermal, Ac-Powered carries zero death-typed MAUDE reports, so the peer set below compares report volume only; both axes are floored at ≥100 reports so the neighborhood stays in the advertised mass.

Similar report volume

Nearest other device types by FDA MAUDE report count (893 here).

Laparoscopic Contraceptive Tubal Occlusion… 893 Flow Cytometric Reagents And Accessories. 896 Intrasaccular Flow Disruption Device 889 Probe, Radiofrequency Lesion 897

Similar death-typed counts

Nearest other device types by death-typed report count (0 here), distinct from the volume row.

Aberrometer, Ophthalmic 0 Accessories, Arthroscopic 0 Accessories, Cleaning Brushes, For Endoscope 0 Accessories, Implant, Dental, Endosseous 0

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

Disclaimer: MAUDE figures for Unit, Cautery, Thermal, Ac-Powered 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 Unit, Cautery, Thermal, Ac-Powered; 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.