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
ligator, hemorrhoidal
Product Code
FHN
Regulation Number
876.4400
Device Class
2
Premarket Reviews
Manufacturer
Decision
BEIJING ZKSK TECHNOLOGY CO.,LTD
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2019
372
372
2020
70
70
2021
16
16
2022
60
60
2023
47
47
Device Problems
MDRs with this Device Problem
Events in those MDRs
Failure to Fire
282
282
Break
86
86
Premature Activation
63
63
Difficult to Remove
49
49
Detachment of Device or Device Component
31
31
Defective Device
23
23
Use of Device Problem
20
20
Human-Device Interface Problem
15
15
Mechanical Problem
14
14
Separation Failure
11
11
Failure to Disconnect
10
10
Entrapment of Device
8
8
Adverse Event Without Identified Device or Use Problem
8
8
Positioning Failure
7
7
Mechanical Jam
6
6
Physical Resistance/Sticking
6
6
Difficult or Delayed Positioning
6
6
Activation, Positioning or Separation Problem
5
5
Device Difficult to Setup or Prepare
5
5
Material Twisted/Bent
4
4
Separation Problem
4
4
Failure to Unfold or Unwrap
3
3
Material Separation
3
3
Misfire
3
3
Retraction Problem
2
2
Difficult or Delayed Separation
2
2
Material Integrity Problem
2
2
Material Deformation
2
2
Device-Device Incompatibility
1
1
Unintended Movement
1
1
Misassembly by Users
1
1
Material Protrusion/Extrusion
1
1
Patient Device Interaction Problem
1
1
Insufficient Information
1
1
Ejection Problem
1
1
Device Markings/Labelling Problem
1
1
Difficult to Advance
1
1
Difficult or Delayed Activation
1
1
Device Fell
1
1
Device Reprocessing Problem
1
1
Component Missing
1
1
Failure to Cut
1
1
Failure to Eject
1
1
Device Dislodged or Dislocated
1
1
Material Split, Cut or Torn
1
1
Activation Problem
1
1
Lack of Effect
1
1
Unintended System Motion
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Consequences Or Impact To Patient
398
398
No Clinical Signs, Symptoms or Conditions
89
89
No Known Impact Or Consequence To Patient
31
31
Hemorrhage/Bleeding
23
23
Foreign Body In Patient
15
15
No Code Available
6
6
Laceration(s)
4
4
Tissue Damage
4
4
Gastrointestinal Hemorrhage
3
3
Unspecified Tissue Injury
3
3
Blood Loss
2
2
No Patient Involvement
2
2
Fever
2
2
Abdominal Pain
1
1
Abscess
1
1
Erythema
1
1
Pain
1
1
Perforation
1
1
Bowel Perforation
1
1
Melena
1
1
Insufficient Information
1
1
-
-