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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 CORP.
  SUBSTANTIALLY EQUIVALENT 2
BOSTON SCIENTIFIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 3
CONMED ENDOSCOPIC TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
ENDOCHOICE, INC.
  SUBSTANTIALLY EQUIVALENT 2
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
MEDI-GLOBE CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
MICRO- TECH (NANJING) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
OLYMPUS MEDICAL SYSTEMS CORP.
  SUBSTANTIALLY EQUIVALENT 1
OVESCO ENDOSCOPY AG
  SUBSTANTIALLY EQUIVALENT 1
STERIS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
UNITED STATES ENDOSCOPY
  SUBSTANTIALLY EQUIVALENT 1
UNITED STATES ENDOSCOPY GROUP, INC.
  SUBSTANTIALLY EQUIVALENT 6
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
2014 345 345
2015 194 194
2016 223 223
2017 154 154
2018 181 181
2019 135 135
2020 487 487
2021 211 211
2022 246 246
2023 209 209
2024 77 77

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Cut 811 811
Break 379 379
Detachment Of Device Component 367 367
Failure to Deliver Energy 280 280
Entrapment of Device 163 163
Unsealed Device Packaging 144 144
Adverse Event Without Identified Device or Use Problem 126 126
Detachment of Device or Device Component 105 105
Retraction Problem 80 80
Electrical /Electronic Property Problem 66 66
Device Contamination with Chemical or Other Material 65 65
Difficult to Open or Close 60 60
Positioning Problem 59 59
Material Deformation 50 50
Device Operates Differently Than Expected 46 46
Defective Device 43 43
Material Twisted/Bent 41 41
Device-Device Incompatibility 38 38
Mechanical Problem 35 35
Use of Device Problem 19 19
Material Split, Cut or Torn 17 17
Failure to Conduct 15 15
Device Dislodged or Dislocated 13 13
Human-Device Interface Problem 13 13
Appropriate Term/Code Not Available 11 11
Difficult to Advance 9 9
Failure to Fold 9 9
Material Separation 9 9
Difficult to Remove 8 8
Failure to Advance 7 7
Off-Label Use 7 7
Therapeutic or Diagnostic Output Failure 6 6
Physical Resistance/Sticking 5 5
Positioning Failure 5 5
Bent 5 5
Sparking 5 5
Failure to Align 5 5
Activation, Positioning or Separation Problem 5 5
Device Markings/Labelling Problem 4 4
Device Contaminated During Manufacture or Shipping 4 4
Overheating of Device 4 4
Inappropriate/Inadequate Shock/Stimulation 3 3
Component Falling 3 3
Material Integrity Problem 3 3
Sticking 3 3
Improper or Incorrect Procedure or Method 3 3
Unintended Movement 3 3
Insufficient Information 3 3
Scratched Material 2 2
Suction Problem 2 2
Tear, Rip or Hole in Device Packaging 2 2
Failure to Fire 2 2
Communication or Transmission Problem 2 2
Connection Problem 2 2
Material Protrusion/Extrusion 2 2
Mechanical Jam 2 2
Device Misassembled During Manufacturing /Shipping 2 2
Physical Resistance 2 2
Fracture 2 2
Device Slipped 2 2
Device Difficult to Setup or Prepare 2 2
Loss of Power 1 1
Premature Activation 1 1
Failure To Service 1 1
Device Alarm System 1 1
Fluid/Blood Leak 1 1
Melted 1 1
Nonstandard Device 1 1
Device Emits Odor 1 1
Energy Output Problem 1 1
Material Fragmentation 1 1
Insufficient Heating 1 1
Material Discolored 1 1
Energy Output To Patient Tissue Incorrect 1 1
Crack 1 1
Degraded 1 1
Loss of or Failure to Bond 1 1
Component(s), broken 1 1
Mechanics Altered 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Impedance Problem 1 1
Separation Failure 1 1
Folded 1 1
Deformation Due to Compressive Stress 1 1
Obstruction of Flow 1 1
Structural Problem 1 1
Device Inoperable 1 1
Unraveled Material 1 1
Device Handling Problem 1 1
Activation Problem 1 1
Wrong Label 1 1
Torn Material 1 1
Protective Measures Problem 1 1
Output Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 1239 1239
No Clinical Signs, Symptoms or Conditions 623 623
No Known Impact Or Consequence To Patient 216 216
No Patient Involvement 140 140
Hemorrhage/Bleeding 106 106
Perforation 46 46
No Code Available 27 27
Tissue Damage 25 25
Insufficient Information 16 16
Unspecified Tissue Injury 11 11
Bowel Perforation 11 11
Burn(s) 11 11
Hematoma 9 9
Device Embedded In Tissue or Plaque 8 8
No Information 8 8
Abdominal Pain 7 7
Foreign Body In Patient 7 7
Pancreatitis 4 4
Fever 4 4
Pain 4 4
Electric Shock 4 4
Peritonitis 2 2
Stenosis 2 2
Blood Loss 2 2
Laceration(s) 2 2
Internal Organ Perforation 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
Failure to Anastomose 1 1
Pneumonia 1 1
Renal Failure 1 1
Shock 1 1
Abrasion 1 1
Bacterial Infection 1 1
Bowel Burn 1 1
Chest Pain 1 1
Death 1 1
Diarrhea 1 1
Tissue Breakdown 1 1
Cancer 1 1
Unspecified Heart Problem 1 1
Discomfort 1 1
Injury 1 1
Foreign body, removal of 1 1
Burn, Thermal 1 1
Surgical procedure, additional 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Boston Scientific Corporation II Mar-04-2021
2 Boston Scientific Corporation II Aug-05-2020
3 Boston Scientific Corporation II Jun-21-2012
4 Olympus America Inc. II Aug-18-2010
5 US Endoscopy Group Inc II Oct-01-2015
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