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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 161 161

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Cut 542 542
Break 236 236
Failure to Deliver Energy 188 188
Unsealed Device Packaging 142 142
Adverse Event Without Identified Device or Use Problem 119 119
Entrapment of Device 105 105
Detachment of Device or Device Component 101 101
Retraction Problem 78 78
Difficult to Open or Close 64 64
Electrical /Electronic Property Problem 63 63
Material Deformation 48 48
Material Twisted/Bent 45 45
Defective Device 42 42
Mechanical Problem 37 37
Positioning Problem 36 36
Device Contamination with Chemical or Other Material 36 36
Device-Device Incompatibility 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
Difficult to Advance 12 12
Appropriate Term/Code Not Available 11 11
Failure to Fold 10 10
Failure to Conduct 9 9
Off-Label Use 7 7
Difficult to Remove 7 7
Therapeutic or Diagnostic Output Failure 5 5
Material Separation 5 5
Fracture 5 5
Failure to Advance 5 5
Device Markings/Labelling Problem 4 4
Device Contaminated During Manufacture or Shipping 4 4
Material Integrity Problem 3 3
Insufficient Information 3 3
Positioning Failure 3 3
Failure to Align 3 3
Physical Resistance/Sticking 3 3
Tear, Rip or Hole in Device Packaging 2 2
Device Difficult to Setup or Prepare 2 2
Device Handling Problem 2 2
Failure to Fire 2 2
Deformation Due to Compressive Stress 2 2
Improper or Incorrect Procedure or Method 2 2
Device Misassembled During Manufacturing /Shipping 2 2
Inappropriate/Inadequate Shock/Stimulation 1 1
Material Protrusion/Extrusion 1 1
Structural Problem 1 1
Device Emits Odor 1 1
Degraded 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 698 698
No Consequences Or Impact To Patient 351 351
No Patient Involvement 133 133
Hemorrhage/Bleeding 107 107
No Known Impact Or Consequence To Patient 65 65
Perforation 38 38
Tissue Damage 22 22
No Code Available 19 19
Insufficient Information 18 18
Unspecified Tissue Injury 11 11
Hematoma 9 9
Abdominal Pain 8 8
Pancreatitis 6 6
Bowel Perforation 6 6
Foreign Body In Patient 6 6
Burn(s) 5 5
Stenosis 4 4
Fever 4 4
Pain 3 3
Electric Shock 3 3
Peritonitis 2 2
Unspecified Hepatic or Biliary Problem 2 2
Gastrointestinal Hemorrhage 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Device Embedded In Tissue or Plaque 2 2
Burn, Thermal 1 1
Bowel Burn 1 1
Abrasion 1 1
Chest Pain 1 1
Diarrhea 1 1
Discomfort 1 1
Inflammation 1 1
Pneumonia 1 1
No Information 1 1
Renal Failure 1 1
Shock 1 1
Swelling/ Edema 1 1
Unspecified Heart Problem 1 1
Unspecified Respiratory Problem 1 1
Melena 1 1
Bacterial Infection 1 1
Cancer 1 1
Tissue Breakdown 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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