2026 data Public-data reference. official source

Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed

Open-data reference.

FDA MAUDE adverse event data · 2005–2026

What the Data Shows About Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed

The FDA MAUDE database aggregates 763 adverse-event reports for Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed spanning the period from 2005 through 2026. Of these, 2 are classified as death reports, 131 as injury reports, and 626 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 8 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 Energy Output Problem topping the list at 81 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 22 years of MAUDE data, with the peak single-year volume reaching 161 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 4 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.

763
Total Reports
2
Death Reports
131
Injury Reports
626
Malfunctions

Event Types

Malfunction 626 (82.0%)
Injury 131 (17.2%)
3 (0.4%)
Death 2 (0.3%)
Other 1 (0.1%)

Patient Outcomes

649 (84.3%)
Required Intervention 70 (9.1%)
Other 38 (4.9%)
R 5 (0.6%)
Hospitalization 4 (0.5%)
Death 2 (0.3%)
H 1 (0.1%)
L 1 (0.1%)

Top Product Problems

Energy Output Problem 81
Use of Device Problem 45
Detachment of Device or Device Component 35
Failure to Cut 33
Break 27
Failure to Seal 25
Device Operates Differently Than Expected 22
Activation Problem 15
Output Problem 15
Activation Failure 13
Difficult to Open or Close 13
Dull, Blunt 12
Energy Output To Patient Tissue Incorrect 9
Mechanics Altered 8
Adverse Event Without Identified Device or Use Problem 5
Contamination 5
Defective Device 5
Device Displays Incorrect Message 5
Entrapment of Device 5
Mechanical Problem 5

Yearly Trend

05
2005: 4
06
2006: 1
07
2007: 4
08
2008: 4
09
2009: 1
10
2010: 9
11
2011: 2
12
2012: 39
13
2013: 161
14
2014: 74
15
2015: 25
16
2016: 52
17
2017: 51
18
2018: 14
19
2019: 20
20
2020: 59
21
2021: 47
22
2022: 31
23
2023: 27
24
2024: 92
25
2025: 38
26
2026: 8

Related Entities for Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed

Event Locations

497 (65.1%)
I 205 (26.9%)
HOSPITAL 47 (6.2%)
NO INFORMATION 14 (1.8%)

Compare STRYKER SUSTAINABILITY SOLUTIONS LAKELAND vs STERILMED, INC. →

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.