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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
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 1
WILSON-COOK MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
YANGZHOU FARTLEY MEDICAL INSTRUMENT TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 135 135
2020 487 487
2021 211 211
2022 246 246
2023 209 209
2024 103 103

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Cut 531 531
Break 225 225
Failure to Deliver Energy 177 177
Unsealed Device Packaging 142 142
Adverse Event Without Identified Device or Use Problem 107 107
Entrapment of Device 105 105
Detachment of Device or Device Component 94 94
Retraction Problem 78 78
Electrical /Electronic Property Problem 62 62
Difficult to Open or Close 58 58
Material Deformation 48 48
Material Twisted/Bent 43 43
Defective Device 42 42
Positioning Problem 36 36
Device-Device Incompatibility 35 35
Device Contamination with Chemical or Other Material 35 35
Mechanical Problem 35 35
Use of Device Problem 20 20
Material Split, Cut or Torn 16 16
Device Dislodged or Dislocated 14 14
Human-Device Interface Problem 13 13
Appropriate Term/Code Not Available 11 11
Failure to Fold 10 10
Difficult to Advance 9 9
Failure to Conduct 8 8
Off-Label Use 7 7
Difficult to Remove 6 6
Material Separation 5 5
Failure to Advance 5 5
Therapeutic or Diagnostic Output Failure 5 5
Device Markings/Labelling Problem 4 4
Device Contaminated During Manufacture or Shipping 4 4
Physical Resistance/Sticking 3 3
Material Integrity Problem 3 3
Failure to Align 3 3
Positioning Failure 3 3
Fracture 2 2
Device Difficult to Setup or Prepare 2 2
Tear, Rip or Hole in Device Packaging 2 2
Improper or Incorrect Procedure or Method 2 2
Insufficient Information 2 2
Device Handling Problem 2 2
Device Misassembled During Manufacturing /Shipping 2 2
Failure to Fire 2 2
Deformation Due to Compressive Stress 2 2
Connection Problem 1 1
Activation, Positioning or Separation Problem 1 1
Failure to Disconnect 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Impedance Problem 1 1
Unintended Movement 1 1
Wrong Label 1 1
Material Protrusion/Extrusion 1 1
Mechanical Jam 1 1
Protective Measures Problem 1 1
Scratched Material 1 1
Suction Problem 1 1
Structural Problem 1 1
Inappropriate/Inadequate Shock/Stimulation 1 1
Unraveled Material 1 1
Fluid/Blood Leak 1 1
Loss of Power 1 1
Premature Activation 1 1
Material Fragmentation 1 1
Insufficient Heating 1 1
Nonstandard Device 1 1
Device Emits Odor 1 1
Energy Output Problem 1 1
Material Discolored 1 1
Device Alarm System 1 1
Crack 1 1
Degraded 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 648 648
No Consequences Or Impact To Patient 351 351
No Patient Involvement 133 133
Hemorrhage/Bleeding 101 101
No Known Impact Or Consequence To Patient 65 65
Perforation 35 35
Tissue Damage 22 22
No Code Available 19 19
Insufficient Information 17 17
Unspecified Tissue Injury 11 11
Hematoma 9 9
Abdominal Pain 7 7
Bowel Perforation 6 6
Foreign Body In Patient 6 6
Burn(s) 5 5
Pancreatitis 4 4
Electric Shock 3 3
Fever 3 3
Pain 3 3
Peritonitis 2 2
Stenosis 2 2
Device Embedded In Tissue or Plaque 2 2
Gastrointestinal Hemorrhage 2 2
Melena 1 1
Unspecified Hepatic or Biliary Problem 1 1
Swelling/ Edema 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
No Information 1 1
Cancer 1 1
Unspecified Heart Problem 1 1
Tissue Breakdown 1 1
Discomfort 1 1
Burn, Thermal 1 1
Pneumonia 1 1
Renal Failure 1 1
Shock 1 1
Chest Pain 1 1
Diarrhea 1 1
Abrasion 1 1
Bacterial Infection 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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