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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device ligator, hemorrhoidal
Product CodeFHN
Regulation Number 876.4400
Device Class 2


Premarket Reviews
ManufacturerDecision
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

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