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2026 data FDA MAUDE openFDA FDA Class II

Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue

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 Surgical Device LIGHT-BOOK · MAUDE

#749 of 1000 · 770 reports · 2006–2026

  • BOOK 770 reports
  • RANK #749 of 1000
  • DEATH 86 death-typed
  • INJ 454 injury-typed
  • MALF 224 malfunction
  • SPAN 2006–2026
  • PEAK 2023: 99
  • PHOTO Surgeon'S Gloves

Nearest event-volume peer: Surgeon'S Gloves (0 report gap)

Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue sits #749 of 1000 among tracked device types with 770 MAUDE reports spanning 2006–2026. 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 sit below the device-type norm

Surgical Device carries 29.1% MALFUNCTION-coded reports, 35.7pp below the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 11.2% corpus 1.5% · above corpus mean (+9.7 pp)
  • INJ 59.0% corpus 30.3% · above corpus mean (+28.7 pp)
  • MALF 29.1% corpus 64.8% · below corpus mean (-35.7 pp)

Lead product-problem code Adverse Event Without Identified Device or Use Problem is 59% of coded problems · Lead manufacturer PERFUSION SYSTEMS accounts for 53% of manufacturer-tagged reports · Top event location is 54% of location-tagged rows .

Surgical Device in the event-volume neighbourhood

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

reports

What this shows Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue carries 770 MAUDE reports, ranked #749 of 1000.

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

Event Types

Injury 454 (59.0%)
Malfunction 224 (29.1%)
Death 86 (11.2%)
Other 5 (0.6%)
1 (0.1%)

Patient Outcomes

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

200 (18.4%)
Required Intervention 186 (17.1%)
R 170 (15.6%)
Life Threatening 166 (15.2%)
Hospitalization 86 (7.9%)
Death 76 (7.0%)
L 62 (5.7%)
Other 48 (4.4%)
O 29 (2.7%)
H 26 (2.4%)
S 19 (1.7%)
D 13 (1.2%)
Disability 7 (0.6%)
C 1 (0.1%)

Top Product Problems

Adverse Event Without Identified Device or Use Problem 459
Detachment Of Device Component 47
Break 43
Obstruction of Flow 26
Material Deformation 22
Insufficient Device Problem Information 20
Detachment of Device or Device Component 17
Device Operates Differently Than Expected 17
Material Separation 15
Failure To Adhere Or Bond 14
High impedance 14
Use of Device Problem 14
Device Dislodged or Dislocated 12
Material Puncture/Hole 10
Crack 8
Device Displays Incorrect Message 8
Device Inoperable 8
Material Fragmentation 7
Positioning Problem 7
Device Handling Problem 6

Yearly Trend

06
2006: 1
09
2009: 8
10
2010: 23
11
2011: 21
12
2012: 21
13
2013: 13
14
2014: 15
15
2015: 31
16
2016: 76
17
2017: 55
18
2018: 61
19
2019: 49
20
2020: 37
21
2021: 63
22
2022: 59
23
2023: 99
24
2024: 59
25
2025: 48
26
2026: 31

Reports fell to 48 in 2025, down from an average of 79 in the two years before.

Related Entities for Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue

Top Manufacturers

PERFUSION SYSTEMS 156
MEDTRONIC, INC. 121
ST. JUDE MEDICAL 16

Event Locations

417 (54.2%)
I 294 (38.2%)
HOSPITAL 51 (6.6%)
NO INFORMATION 8 (1.0%)

Compare PERFUSION SYSTEMS vs MEDTRONIC, INC. →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Surgical Device: 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 (770 here).

Surgeon'S Gloves 770 Electrosurgical 772 Adhesive 773 Gas Control Unit, Cardiopulmonary Bypass 767

Similar death-typed counts

Nearest other device types by death-typed report count (86 here), distinct from the volume row.

Thoracolumbosacral Pedicle Screw System 86 Pulse-Generator, Pacemaker, External 85 Pump, Infusion, Enteral 85 System, X-Ray, Angiographic 85

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

Disclaimer: MAUDE figures for Surgical Device 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 Surgical Device; 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.