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TPLC
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show TPLC since
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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
LEO MEDICAL CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2018
318
318
2019
372
372
2020
70
70
2021
16
16
2022
60
60
2023
35
35
Device Problems
MDRs with this Device Problem
Events in those MDRs
Failure to Fire
367
367
Premature Activation
146
146
Break
129
129
Positioning Failure
123
123
Detachment of Device or Device Component
46
46
Difficult to Remove
43
43
Defective Device
27
27
Use of Device Problem
21
21
Human-Device Interface Problem
16
16
Mechanical Problem
13
13
Separation Failure
13
13
Difficult or Delayed Positioning
12
12
Failure to Disconnect
10
10
Adverse Event Without Identified Device or Use Problem
9
9
Activation, Positioning or Separation Problem
8
8
Entrapment of Device
8
8
Failure To Adhere Or Bond
8
8
Defective Component
7
7
Misfire
6
6
Mechanical Jam
6
6
Physical Resistance/Sticking
6
6
Device Difficult to Setup or Prepare
5
5
Material Twisted/Bent
4
4
Separation Problem
4
4
Material Separation
3
3
Failure to Unfold or Unwrap
3
3
Loss of or Failure to Bond
3
3
Retraction Problem
2
2
Difficult or Delayed Separation
2
2
Material Deformation
2
2
Material Integrity Problem
2
2
Material Protrusion/Extrusion
1
1
Device Fell
1
1
Activation Problem
1
1
Unintended Movement
1
1
Misassembly by Users
1
1
Insufficient Information
1
1
Patient Device Interaction Problem
1
1
Material Split, Cut or Torn
1
1
Ejection Problem
1
1
Failure to Eject
1
1
Improper or Incorrect Procedure or Method
1
1
Device Reprocessing Problem
1
1
Detachment Of Device Component
1
1
Unintended System Motion
1
1
Component Missing
1
1
Difficult or Delayed Activation
1
1
Failure to Form Staple
1
1
Failure to Cut
1
1
Device Markings/Labelling Problem
1
1
Device Operates Differently Than Expected
1
1
Device-Device Incompatibility
1
1
Difficult to Advance
1
1
Device Dislodged or Dislocated
1
1
Device Contamination with Chemical or Other Material
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Consequences Or Impact To Patient
682
682
No Clinical Signs, Symptoms or Conditions
82
82
No Known Impact Or Consequence To Patient
54
54
Hemorrhage/Bleeding
21
21
Foreign Body In Patient
15
15
No Patient Involvement
10
10
Tissue Damage
7
7
No Code Available
7
7
Blood Loss
4
4
Laceration(s)
4
4
Gastrointestinal Hemorrhage
3
3
Unspecified Tissue Injury
2
2
Insufficient Information
1
1
Melena
1
1
Device Embedded In Tissue or Plaque
1
1
No Information
1
1
Pain
1
1
Perforation
1
1
Skin Tears
1
1
Erythema
1
1
Fever
1
1
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