Quick Links: Skip to main page content
Skip to Search
Skip to Topics Menu
Skip to Common Links
U.S. Food & Drug Administration
Follow FDA
En Español
Search FDA
Home
Food
Drugs
Medical Devices
Radiation-Emitting Products
Vaccines, Blood & Biologics
Animal & Veterinary
Cosmetics
Tobacco Products
TPLC - Total Product Life Cycle
FDA Home
medical devices
databases
-
510(k)
|
DeNovo
|
Registration & Listing
|
Adverse Events
|
Recalls
|
PMA
|
HDE
|
Classification
|
Standards
CFR Title 21
|
Radiation-Emitting Products
|
X-Ray Assembler
|
Medsun Reports
|
CLIA
|
TPLC
New Search
show TPLC since
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
Back to Search Results
Device
coagulator-cutter, endoscopic, bipolar (and accessories)
Product Code
HIN
Regulation Number
884.4150
Device Class
2
Premarket Reviews
Manufacturer
Decision
ETHICON, INC.
SUBSTANTIALLY EQUIVALENT
1
GYRUS ACMI, INC.
SUBSTANTIALLY EQUIVALENT
2
KARL STORZ ENDOSCOPY-AMERICA, INC.
SUBSTANTIALLY EQUIVALENT
1
LINA MEDICAL APS
SUBSTANTIALLY EQUIVALENT
1
MECTRA LABS, INC.
SUBSTANTIALLY EQUIVALENT
1
OLYMPUS WINTER & IBE GMBH
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2014
12
12
2015
8
8
2016
2
2
2017
8
8
2018
2
2
2019
4
4
2020
9
9
2021
10
10
2022
1
1
2023
9
9
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
31
31
Material Separation
13
13
Fracture
8
8
Mechanical Problem
7
7
Material Fragmentation
6
6
Torn Material
4
4
Difficult to Remove
3
3
Flare or Flash
2
2
Failure to Cut
2
2
Detachment of Device or Device Component
2
2
Device Operates Differently Than Expected
1
1
Electrical Shorting
1
1
Arcing of Electrodes
1
1
Defective Component
1
1
Separation Failure
1
1
Therapy Delivered to Incorrect Body Area
1
1
Detachment Of Device Component
1
1
Unintended Power Up
1
1
Entrapment of Device
1
1
Material Integrity Problem
1
1
Material Protrusion/Extrusion
1
1
Physical Property Issue
1
1
Therapeutic or Diagnostic Output Failure
1
1
No Apparent Adverse Event
1
1
Insufficient Information
1
1
Device Handling Problem
1
1
Excessive Heating
1
1
Bent
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Consequences Or Impact To Patient
22
22
No Known Impact Or Consequence To Patient
14
14
Insufficient Information
10
10
No Clinical Signs, Symptoms or Conditions
9
9
Burn(s)
3
3
Foreign Body In Patient
3
3
Device Embedded In Tissue or Plaque
2
2
Fibrosis
1
1
No Information
1
1
Missing Value Reason
1
1
Patient Problem/Medical Problem
1
1
Partial thickness (Second Degree) Burn
1
1
-
-