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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
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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