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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
OLYMPUS MEDICAL SYSTEMS CORP.
  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
2017 154 154
2018 181 181
2019 135 135
2020 487 487
2021 211 211
2022 195 195

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Cut 536 536
Break 214 214
Unsealed Device Packaging 141 141
Failure to Deliver Energy 128 128
Entrapment of Device 112 112
Adverse Event Without Identified Device or Use Problem 77 77
Detachment of Device or Device Component 74 74
Retraction Problem 70 70
Electrical /Electronic Property Problem 56 56
Difficult to Open or Close 56 56
Positioning Problem 56 56
Device Contamination with Chemical or Other Material 42 42
Defective Device 35 35
Detachment Of Device Component 35 35
Material Twisted/Bent 28 28
Mechanical Problem 25 25
Material Deformation 22 22
Device-Device Incompatibility 20 20
Device Operates Differently Than Expected 16 16
Material Split, Cut or Torn 12 12
Appropriate Term/Code Not Available 11 11
Human-Device Interface Problem 11 11
Use of Device Problem 11 11
Failure to Advance 7 7
Difficult to Advance 6 6
Therapeutic or Diagnostic Output Failure 5 5
Device Dislodged or Dislocated 5 5
Physical Resistance/Sticking 5 5
Device Markings/Labelling Problem 4 4
Device Contaminated During Manufacture or Shipping 4 4
Activation, Positioning or Separation Problem 4 4
Failure to Fold 4 4
Failure to Conduct 3 3
Positioning Failure 3 3
Difficult to Remove 3 3
Unintended Movement 3 3
Insufficient Information 2 2
Material Integrity Problem 2 2
Connection Problem 2 2
Failure to Align 2 2
Suction Problem 2 2
Device Difficult to Setup or Prepare 2 2
Overheating of Device 2 2
Device Emits Odor 1 1
Energy Output Problem 1 1
Material Fragmentation 1 1
Material Discolored 1 1
Device Alarm System 1 1
Bent 1 1
Crack 1 1
Off-Label Use 1 1
Loss of Power 1 1
Premature Activation 1 1
Material Separation 1 1
Inappropriate/Inadequate Shock/Stimulation 1 1
Device Slipped 1 1
Sticking 1 1
Unraveled Material 1 1
Tear, Rip or Hole in Device Packaging 1 1
Obstruction of Flow 1 1
Structural Problem 1 1
Improper or Incorrect Procedure or Method 1 1
Separation Failure 1 1
Physical Resistance 1 1
Failure to Fire 1 1
Deformation Due to Compressive Stress 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Device Misassembled During Manufacturing /Shipping 1 1
Material Protrusion/Extrusion 1 1
Output Problem 1 1
Device Handling Problem 1 1
Torn Material 1 1
Protective Measures Problem 1 1
Scratched Material 1 1
Activation Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 606 606
No Clinical Signs, Symptoms or Conditions 333 333
No Patient Involvement 139 139
No Known Impact Or Consequence To Patient 123 123
Hemorrhage/Bleeding 74 74
Perforation 34 34
Tissue Damage 23 23
No Code Available 22 22
Insufficient Information 12 12
Hematoma 8 8
Burn(s) 6 6
Bowel Perforation 6 6
Foreign Body In Patient 4 4
Pain 4 4
Unspecified Tissue Injury 4 4
Electric Shock 3 3
Blood Loss 2 2
Device Embedded In Tissue or Plaque 2 2
No Information 2 2
Pancreatitis 2 2
Internal Organ Perforation 2 2
Abdominal Pain 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
Abrasion 1 1
Bowel Burn 1 1
Fever 1 1
Unspecified Hepatic or Biliary Problem 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Cancer 1 1
Unspecified Heart Problem 1 1
Melena 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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