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2026 data FDA MAUDE openFDA FDA Class I

Cannula, Surgical, General & Plastic Surgery

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 I (lowest regulatory risk tier, general controls), regulated under 21 CFR §878.4800 (General, Plastic Surgery panel).

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FDA MAUDE casebook

openFDA event book Cannula, Surgical, General & Plastic Surgery LIGHT-BOOK · MAUDE

#655 of 1000 · 1,037 reports · 1992–2026

  • BOOK 1,037 reports
  • RANK #655 of 1000
  • DEATH 1 death-typed
  • INJ 150 injury-typed
  • MALF 860 malfunction
  • SPAN 1992–2026
  • PEAK 2020: 158
  • PHOTO Holder

Nearest event-volume peer: Holder, Needle, Gastroenterologic (1 report gap)

Cannula, Surgical, General & Plastic Surgery sits #655 of 1000 among tracked device types with 1,037 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

Cannula, Surgical, General & Plastic Surgery carries 82.9% MALFUNCTION-coded reports, 18.1pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.1% corpus 1.5% · below corpus mean (-1.4 pp)
  • INJ 14.5% corpus 30.3% · below corpus mean (-15.8 pp)
  • MALF 82.9% corpus 64.8% · above corpus mean (+18.1 pp)

Lead product-problem code Break is 27% of coded problems · Lead manufacturer ETHICON INC. accounts for 39% of manufacturer-tagged reports · Top event location I is 47% of location-tagged rows .

Cannula, Surgical, General & Plastic Surgery in the event-volume neighbourhood

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

reports

What this shows Cannula, Surgical, General & Plastic Surgery carries 1,037 MAUDE reports, ranked #655 of 1000.

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

Event Types

Malfunction 860 (82.9%)
Injury 150 (14.5%)
Other 23 (2.2%)
3 (0.3%)
Death 1 (0.1%)

Patient Outcomes

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

839 (80.8%)
Required Intervention 114 (11.0%)
Other 67 (6.4%)
Hospitalization 6 (0.6%)
R 5 (0.5%)
O 2 (0.2%)
Disability 2 (0.2%)
L 1 (0.1%)
S 1 (0.1%)
Death 1 (0.1%)
Life Threatening 1 (0.1%)

Top Product Problems

Break 271
Device-Device Incompatibility 125
Device Markings/Labelling Problem 120
Adverse Event Without Identified Device or Use Problem 74
Delivered as Unsterile Product 57
Crack 42
Tear, Rip or Hole in Device Packaging 42
Material Deformation 40
Material Twisted/Bent 31
Detachment Of Device Component 29
Material Separation 23
Detachment of Device or Device Component 22
Fluid/Blood Leak 21
Mechanical Jam 18
Appropriate Device Problem Term/Code Not Available 17
Fracture 14
Material Fragmentation 14
Tip breakage 13
Contamination /Decontamination Problem 12
Entrapment of Device 12

Yearly Trend

92
1992: 1
95
1995: 3
96
1996: 1
97
1997: 11
98
1998: 3
99
1999: 5
00
2000: 2
01
2001: 2
02
2002: 4
03
2003: 5
04
2004: 4
05
2005: 6
06
2006: 11
07
2007: 7
08
2008: 15
09
2009: 14
10
2010: 14
11
2011: 11
12
2012: 3
13
2013: 7
14
2014: 8
15
2015: 11
16
2016: 63
17
2017: 46
18
2018: 58
19
2019: 62
20
2020: 158
21
2021: 149
22
2022: 83
23
2023: 74
24
2024: 98
25
2025: 71
26
2026: 27

Reports in 2025 (71) held close to the prior two-year average of 86.

Related Entities for Cannula, Surgical, General & Plastic Surgery

Top Manufacturers

ETHICON INC. 303
DEPUY MITEK LLC US 154
DEPUY SPINE INC 120
ETHICON ENDO-SURGERY, LLC. 67
SYNTHES GMBH 63
COVIDIEN 38
DEPUY MITEK 26
WRIGHTS LANE SYNTHES USA PRODUCTS LLC 16

Event Locations

I 491 (47.3%)
446 (43.0%)
HOSPITAL 71 (6.8%)
OTHER 14 (1.4%)
NO INFORMATION 6 (0.6%)
AMBULATORY SURGICAL FACILITY 4 (0.4%)
NOT APPLICABLE 4 (0.4%)
OUTPATIENT TREATMENT FACILITY 1 (0.1%)

Compare ETHICON INC. vs DEPUY MITEK LLC US →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Cannula, Surgical, General & Plastic Surgery: 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 (1,037 here).

Holder, Needle, Gastroenterologic 1,038 Blood Establishment Computer Software And A… 1,034 Motor 1,030 Restraint, Protective 1,027

Similar death-typed counts

Nearest other device types by death-typed report count (1 here), distinct from the volume row.

Abutment, Implant, Dental, Endosseous 1 Active Implantable Bone Conduction Hearing… 1 Aid, Surgical, Viscoelastic 1 Alarm, Conditioned Response Enuresis 1

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

Disclaimer: MAUDE figures for Cannula, Surgical, General & Plastic Surgery 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 Cannula, Surgical, General & Plastic Surgery; 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.