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Cannula, Surgical, General & Plastic Surgery

Open-data reference.

FDA MAUDE adverse event data · 1992–2026

What the Data Shows About Cannula, Surgical, General & Plastic Surgery

The FDA MAUDE database aggregates 1,021 adverse-event reports for Cannula, Surgical, General & Plastic Surgery spanning the period from 1992 through 2026. Of these, 1 is classified as a death report, 150 as injury reports, and 844 as malfunction reports under FDA adverse-event categorization rules. Report counts do not by themselves indicate a device is unsafe — widely used devices and longer market histories naturally generate larger raw counts, so proportional and comparative reads are more informative than totals alone.

The adverse-event profile breaks down across 5 distinct event types and 11 reported patient-outcome categories, giving a multi-dimensional view that goes beyond a single headline number. A total of 20 distinct product-problem codes appear in the reports, with Break topping the list at 206 reports. Reports are associated with 10 different manufacturers in the MAUDE record, reflecting both OEMs and repackagers of this device category.

Annual reporting volume is tracked across 33 years of MAUDE data, with the peak single-year volume reaching 158 reports — trend shape often reflects changes in device adoption, reporting rules, or FDA enforcement focus rather than underlying device behavior alone. Events are documented across 8 reported care-setting categories (hospital, home, ambulatory surgery center, etc.). All figures reflect the openFDA MAUDE snapshot last refreshed on . This page is informational and is not medical advice — discuss device-safety questions with your healthcare provider.

1,021
Total Reports
1
Death Reports
150
Injury Reports
844
Malfunctions

Event Types

Malfunction 844 (82.7%)
Injury 150 (14.7%)
Other 23 (2.3%)
3 (0.3%)
Death 1 (0.1%)

Patient Outcomes

830 (80.7%)
Required Intervention 113 (11.0%)
Other 67 (6.5%)
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 206
Device Markings/Labelling Problem 120
Device-Device Incompatibility 117
Adverse Event Without Identified Device or Use Problem 71
Delivered as Unsterile Product 57
Tear, Rip or Hole in Device Packaging 42
Material Deformation 39
Crack 33
Material Twisted/Bent 30
Detachment of Device or Device Component 21
Fluid/Blood Leak 21
Material Separation 18
Mechanical Jam 17
Appropriate Term/Code Not Available 16
Contamination /Decontamination Problem 12
Entrapment of Device 12
Material Fragmentation 10
Device Contaminated During Manufacture or Shipping 9
Material Integrity Problem 9
Packaging Problem 8

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: 11

Related Entities for Cannula, Surgical, General & Plastic Surgery

Event Locations

I 491 (48.1%)
430 (42.1%)
HOSPITAL 71 (7.0%)
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 →

Data Source

FDA Manufacturer and User Facility Device Experience (MAUDE) database via the openFDA API. Reports are submitted by manufacturers, healthcare facilities, and patients. Report counts do not indicate a device is unsafe — higher-use devices naturally generate more reports.

Disclaimer: This information is provided for informational purposes only and does not constitute professional advice. Data is sourced from the FDA MAUDE database. Consult a qualified professional before making decisions based on this data.