Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
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 77 77

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Cut 525 525
Break 220 220
Failure to Deliver Energy 174 174
Unsealed Device Packaging 142 142
Entrapment of Device 105 105
Adverse Event Without Identified Device or Use Problem 105 105
Detachment of Device or Device Component 94 94
Retraction Problem 77 77
Electrical /Electronic Property Problem 61 61
Difficult to Open or Close 54 54
Material Deformation 46 46
Defective Device 42 42
Material Twisted/Bent 40 40
Mechanical Problem 35 35
Positioning Problem 35 35
Device-Device Incompatibility 35 35
Device Contamination with Chemical or Other Material 35 35
Use of Device Problem 19 19
Material Split, Cut or Torn 16 16
Device Dislodged or Dislocated 13 13
Human-Device Interface Problem 13 13
Appropriate Term/Code Not Available 11 11
Failure to Fold 9 9
Difficult to Advance 9 9
Failure to Conduct 7 7
Off-Label Use 7 7
Difficult to Remove 6 6
Failure to Advance 5 5
Therapeutic or Diagnostic Output Failure 5 5
Material Separation 5 5
Device Contaminated During Manufacture or Shipping 4 4
Device Markings/Labelling Problem 4 4
Failure to Align 3 3
Physical Resistance/Sticking 3 3
Positioning Failure 3 3
Material Integrity Problem 3 3
Improper or Incorrect Procedure or Method 2 2
Failure to Fire 2 2
Tear, Rip or Hole in Device Packaging 2 2
Fracture 2 2
Device Difficult to Setup or Prepare 2 2
Device Misassembled During Manufacturing /Shipping 2 2
Insufficient Information 2 2
Premature Activation 1 1
Fluid/Blood Leak 1 1
Nonstandard Device 1 1
Crack 1 1
Device Alarm System 1 1
Impedance Problem 1 1
Scratched Material 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Unintended Movement 1 1
Wrong Label 1 1
Device Emits Odor 1 1
Material Fragmentation 1 1
Device Handling Problem 1 1
Material Protrusion/Extrusion 1 1
Mechanical Jam 1 1
Protective Measures Problem 1 1
Loss of Power 1 1
Structural Problem 1 1
Deformation Due to Compressive Stress 1 1
Activation, Positioning or Separation Problem 1 1
Suction Problem 1 1
Degraded 1 1
Insufficient Heating 1 1
Connection Problem 1 1
Unraveled Material 1 1
Energy Output Problem 1 1
Inappropriate/Inadequate Shock/Stimulation 1 1
Material Discolored 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 623 623
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 16 16
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
-
-