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TPLC
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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
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
Difficult or Delayed Positioning
6
6
Mechanical Jam
6
6
Physical Resistance/Sticking
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
Misfire
3
3
Material Separation
3
3
Failure to Unfold or Unwrap
3
3
Retraction Problem
2
2
Material Deformation
2
2
Material Integrity Problem
2
2
Difficult or Delayed Separation
2
2
Lack of Effect
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
Material Protrusion/Extrusion
1
1
Difficult or Delayed Activation
1
1
Failure to Cut
1
1
Device Markings/Labelling Problem
1
1
Device-Device Incompatibility
1
1
Difficult to Advance
1
1
Device Dislodged or Dislocated
1
1
Component Missing
1
1
Unintended System Motion
1
1
Device Reprocessing Problem
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
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