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2026 data FDA MAUDE openFDA FDA Class II

Trocar

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 §870.1390 (Cardiovascular panel).

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FDA MAUDE casebook

openFDA event book Trocar LIGHT-BOOK · MAUDE

#503 of 1000 · 1,994 reports · 1992–2026

  • BOOK 1,994 reports
  • RANK #503 of 1000
  • DEATH 59 death-typed
  • INJ 933 injury-typed
  • MALF 955 malfunction
  • SPAN 1992–2026
  • PEAK 2006: 178
  • PHOTO Tourniquet, Pneumatic

Nearest event-volume peer: Tourniquet, Pneumatic (5 report gap)

Trocar sits #503 of 1000 among tracked device types with 1,994 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 sit below the device-type norm

Trocar carries 47.9% MALFUNCTION-coded reports, 16.9pp below the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 3.0% corpus 1.5% · above corpus mean (+1.5 pp)
  • INJ 46.8% corpus 30.3% · above corpus mean (+16.5 pp)
  • MALF 47.9% corpus 64.8% · below corpus mean (-16.9 pp)

Lead product-problem code Adverse Event Without Identified Device or Use Problem is 32% of coded problems · Lead manufacturer ST. JUDE MEDICAL accounts for 41% of manufacturer-tagged reports · Top event location is 60% of location-tagged rows .

Trocar in the event-volume neighbourhood

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

reports

What this shows Trocar carries 1,994 MAUDE reports, ranked #503 of 1000.

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

Event Types

Malfunction 955 (47.9%)
Injury 933 (46.8%)
Death 59 (3.0%)
Other 29 (1.5%)
18 (0.9%)

Patient Outcomes

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

1,028 (46.9%)
Required Intervention 500 (22.8%)
Other 258 (11.8%)
R 116 (5.3%)
Life Threatening 76 (3.5%)
Hospitalization 61 (2.8%)
Death 57 (2.6%)
L 56 (2.6%)
O 12 (0.5%)
H 11 (0.5%)
Invalid Data 8 (0.4%)
D 4 (0.2%)
Disability 2 (0.1%)
S 1 (0.0%)
Congenital Anomaly 1 (0.0%)

Top Product Problems

Adverse Event Without Identified Device or Use Problem 714
Break 214
Detachment Of Device Component 193
Replace 185
Balloon rupture 105
Component(s), broken 96
Balloon burst 95
Device, removal of (non-implant) 89
Component Falling 86
Disengaged 67
Difficult to Insert 62
Insufficient Device Problem Information 58
Material Separation 52
Activation, Positioning or Separation Problem 32
Fracture 32
Device, or device fragments remain in patient 29
Air Leak 26
Inflation Problem 25
Trocar failure 25
Material Fragmentation 22

Yearly Trend

92
1992: 10
93
1993: 24
94
1994: 24
95
1995: 5
96
1996: 1
97
1997: 3
98
1998: 3
99
1999: 1
00
2000: 91
01
2001: 44
02
2002: 89
03
2003: 62
04
2004: 50
05
2005: 71
06
2006: 178
07
2007: 106
08
2008: 2
09
2009: 17
10
2010: 33
11
2011: 68
12
2012: 58
13
2013: 37
14
2014: 64
15
2015: 52
16
2016: 62
17
2017: 70
18
2018: 85
19
2019: 95
20
2020: 108
21
2021: 78
22
2022: 61
23
2023: 109
24
2024: 105
25
2025: 70
26
2026: 58

Reports in 2025 (70) held close to the prior two-year average of 107.

Related Entities for Trocar

Top Manufacturers

ST. JUDE MEDICAL 404
PONCE - USS 339
ABBOTT MEDICAL 84
MEDTRONIC MEXICO 75
PONCE-USS 38
ST. JUDE MEDICAL, INC. 36

Event Locations

1,190 (59.7%)
I 493 (24.7%)
HOSPITAL 264 (13.2%)
INVALID DATA 18 (0.9%)
NO INFORMATION 14 (0.7%)
NOT APPLICABLE 8 (0.4%)
OTHER 3 (0.2%)
OUTPATIENT TREATMENT FACILITY 2 (0.1%)
AMBULATORY SURGICAL FACILITY 1 (0.1%)
UNKNOWN 1 (0.1%)

Compare ST. JUDE MEDICAL vs PONCE - USS →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Trocar: 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 (1,994 here).

Tourniquet, Pneumatic 1,989 Monitor, Physiological, Patient 1,983 Radioimmunoassay, Total Triiodothyronine 1,979 Electrode, Pacemaker, Temporary 2,012

Similar death-typed counts

Nearest other device types by death-typed report count (59 here), distinct from the volume row.

Appliance 59 Occluder, Patent Ductus, Arteriosus 60 Prosthesis 58 Pump, Infusion, Elastomeric 58

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

Disclaimer: MAUDE figures for Trocar 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 Trocar; 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.