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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
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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