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
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
Back to Search Results
Device
forceps, biopsy, electric
Regulation Description
Endoscopic electrosurgical unit and accessories.
Product Code
KGE
Regulation Number
876.4300
Device Class
2
Premarket Reviews
Manufacturer
Decision
BEIJING ZKSK TECHNOLOGY CO.,LTD
SUBSTANTIALLY EQUIVALENT
1
FUJIFILM CORPORATION
SUBSTANTIALLY EQUIVALENT
1
HANGZHOU AGS MEDTECH CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
MICRO-TECH (NANJING) CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2020
7
7
2021
24
24
2022
16
16
2023
8
8
2024
9
9
Device Problems
MDRs with this Device Problem
Events in those MDRs
Unintended Movement
13
13
Adverse Event Without Identified Device or Use Problem
10
10
Illegible Information
7
7
Insufficient Heating
3
3
Mechanical Jam
3
3
Material Twisted/Bent
3
3
Failure to Power Up
3
3
Failure to Align
2
2
Suction Failure
2
2
Complete Loss of Power
2
2
Communication or Transmission Problem
2
2
Overheating of Device
2
2
Material Deformation
2
2
Dull, Blunt
2
2
Intermittent Loss of Power
2
2
Break
2
2
Mechanical Problem
2
2
Failure to Cut
2
2
Energy Output Problem
1
1
Failure to Deliver Shock/Stimulation
1
1
Unexpected Shutdown
1
1
Difficult to Open or Close
1
1
Failure to Clean Adequately
1
1
Noise, Audible
1
1
Off-Label Use
1
1
Packaging Problem
1
1
Device Contaminated During Manufacture or Shipping
1
1
Use of Device Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
42
42
Perforation
6
6
Hemorrhage/Bleeding
6
6
No Consequences Or Impact To Patient
5
5
No Known Impact Or Consequence To Patient
3
3
Insufficient Information
2
2
Laceration(s) of Esophagus
2
2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
1
1
Unspecified Tissue Injury
1
1
Bacterial Infection
1
1
Pain
1
1
Gastrointestinal Hemorrhage
1
1
-
-