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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device snare, flexible
Product CodeFDI
Regulation Number 876.4300
Device Class 2


Premarket Reviews
ManufacturerDecision
BEIJING ZKSK TECHNOLOGY CO.,LTD
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
FINEMEDIX CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
HANGZHOU AGS MEDTECH CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
HANGZHOU AGS MEDTECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
INCORE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
INTELLIGENT ENDOSCOPY
  SUBSTANTIALLY EQUIVALENT 1
JIANGSU VEDKANG MEDICAL SCIENCE AND TECHNOLOGY CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
STERIS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
UNITED STATES ENDOSCOPY GROUP, INC.
  SUBSTANTIALLY EQUIVALENT 2
WILSON-COOK MEDICAL, INC
  SUBSTANTIALLY EQUIVALENT 1
WILSON-COOK MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
YANGZHOU FARTLEY MEDICAL INSTRUMENT TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ZHEJIANG CHUANGXIANG MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2018 181 181
2019 135 135
2020 487 487
2021 211 211
2022 246 246
2023 149 149

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Cut 541 541
Break 226 226
Failure to Deliver Energy 158 158
Unsealed Device Packaging 144 144
Entrapment of Device 112 112
Adverse Event Without Identified Device or Use Problem 94 94
Detachment of Device or Device Component 90 90
Retraction Problem 74 74
Electrical /Electronic Property Problem 60 60
Positioning Problem 59 59
Difficult to Open or Close 57 57
Device Contamination with Chemical or Other Material 44 44
Defective Device 41 41
Material Deformation 36 36
Mechanical Problem 34 34
Material Twisted/Bent 33 33
Device-Device Incompatibility 24 24
Use of Device Problem 19 19
Material Split, Cut or Torn 15 15
Human-Device Interface Problem 12 12
Appropriate Term/Code Not Available 11 11
Device Operates Differently Than Expected 11 11
Device Dislodged or Dislocated 10 10
Detachment Of Device Component 10 10
Difficult to Advance 8 8
Failure to Fold 7 7
Failure to Advance 6 6
Therapeutic or Diagnostic Output Failure 5 5
Physical Resistance/Sticking 5 5
Device Markings/Labelling Problem 4 4
Device Contaminated During Manufacture or Shipping 4 4
Failure to Conduct 4 4
Difficult to Remove 4 4
Positioning Failure 3 3
Activation, Positioning or Separation Problem 3 3
Unintended Movement 3 3
Insufficient Information 2 2
Connection Problem 2 2
Device Misassembled During Manufacturing /Shipping 2 2
Material Integrity Problem 2 2
Fracture 2 2
Overheating of Device 2 2
Device Difficult to Setup or Prepare 2 2
Material Separation 2 2
Improper or Incorrect Procedure or Method 2 2
Suction Problem 2 2
Tear, Rip or Hole in Device Packaging 2 2
Obstruction of Flow 1 1
Structural Problem 1 1
Failure to Align 1 1
Failure to Fire 1 1
Deformation Due to Compressive Stress 1 1
Inappropriate/Inadequate Shock/Stimulation 1 1
Unraveled Material 1 1
Off-Label Use 1 1
Material Fragmentation 1 1
Fluid/Blood Leak 1 1
Device Emits Odor 1 1
Energy Output Problem 1 1
Loss of Power 1 1
Premature Activation 1 1
Material Discolored 1 1
Device Alarm System 1 1
Crack 1 1
Degraded 1 1
Material Protrusion/Extrusion 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Impedance Problem 1 1
Separation Failure 1 1
Device Handling Problem 1 1
Activation Problem 1 1
Wrong Label 1 1
Torn Material 1 1
Protective Measures Problem 1 1
Scratched Material 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 502 502
No Consequences Or Impact To Patient 485 485
No Patient Involvement 134 134
No Known Impact Or Consequence To Patient 101 101
Hemorrhage/Bleeding 92 92
Perforation 39 39
Tissue Damage 23 23
No Code Available 20 20
Insufficient Information 16 16
Hematoma 9 9
Bowel Perforation 6 6
Unspecified Tissue Injury 5 5
Burn(s) 5 5
Abdominal Pain 5 5
Foreign Body In Patient 5 5
Pain 4 4
Electric Shock 3 3
Pancreatitis 3 3
Internal Organ Perforation 2 2
Peritonitis 2 2
Stenosis 2 2
Discomfort 1 1
Burn, Thermal 1 1
Pneumonia 1 1
Renal Failure 1 1
Shock 1 1
Diarrhea 1 1
Fever 1 1
Abrasion 1 1
Bacterial Infection 1 1
Bowel Burn 1 1
Unspecified Hepatic or Biliary Problem 1 1
Swelling/ Edema 1 1
Cancer 1 1
Unspecified Heart Problem 1 1
Gastrointestinal Hemorrhage 1 1
Melena 1 1
Tissue Breakdown 1 1
Device Embedded In Tissue or Plaque 1 1
No Information 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Boston Scientific Corporation II Mar-04-2021
2 Boston Scientific Corporation II Aug-05-2020
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