2026 data FDA MAUDE openFDA

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 MAUDE casebook

openFDA event book Surgical Device LIGHT-BOOK · MAUDE

#745 of 1000 · 750 reports · 2006–2026

  • BOOK 750 reports
  • RANK #745 of 1000
  • DEATH 86 death-typed
  • INJ 450 injury-typed
  • MALF 208 malfunction
  • SPAN 2006–2026
  • PEAK 2023: 99
  • PHOTO Catheter

Nearest event-volume peer: Catheter, Balloon, Transcervical (3 report gap)

Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue sits #745 of 1000 among tracked device types with 750 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 →

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 11.5% corpus 1.5% · above corpus mean (+9.9 pp)
  • INJ 60.0% corpus 30.4% · above corpus mean (+29.6 pp)
  • MALF 27.7% corpus 64.5% · below corpus mean (-36.8 pp)

Lead product-problem code Adverse Event Without Identified Device or Use Problem is 69% of coded problems · Lead manufacturer PERFUSION SYSTEMS accounts for 52% of manufacturer-tagged reports · Top event location is 53% 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 750 MAUDE reports, ranked #745 of 1000.

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

Event Types

Injury 450 (60.0%)
Malfunction 208 (27.7%)
Death 86 (11.5%)
Other 5 (0.7%)
1 (0.1%)

Patient Outcomes

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

185 (17.4%)
Required Intervention 185 (17.4%)
R 168 (15.8%)
Life Threatening 163 (15.3%)
Hospitalization 86 (8.1%)
Death 76 (7.1%)
L 61 (5.7%)
Other 48 (4.5%)
O 29 (2.7%)
H 26 (2.4%)
S 19 (1.8%)
D 13 (1.2%)
Disability 7 (0.7%)

Top Product Problems

Adverse Event Without Identified Device or Use Problem 431
Detachment Of Device Component 37
Break 28
Material Deformation 20
Obstruction of Flow 16
Detachment of Device or Device Component 14
Material Puncture/Hole 10
Material Separation 10
Use of Device Problem 10
Failure To Adhere Or Bond 9
Crack 7
Device Dislodged or Dislocated 5
Fracture 5
High impedance 5
Material Fragmentation 5
Malposition of Device 4
Fluid/Blood Leak 3
Insufficient Information 3
Mechanical Problem 3
No Flow 3

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: 11

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

Top Manufacturers

Event Locations

397 (52.9%)
I 294 (39.2%)
HOSPITAL 51 (6.8%)
NO INFORMATION 8 (1.1%)

Compare PERFUSION SYSTEMS vs MEDTRONIC, INC. →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Surgical Device, 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 (750 here).

Similar death-typed counts

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

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.