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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device snare, flexible
Regulation Description Endoscopic electrosurgical unit and accessories.
Product CodeFDI
Regulation Number 876.4300
Device Class 2


Premarket Reviews
ManufacturerDecision
BOSTON SCIENTIFIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
FINEMEDIX CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
HANGZHOU AGS MEDTECH CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
INTELLIGENT ENDOSCOPY
  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
ZHEJIANG CHUANGXIANG MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 154 154
2018 180 180
2019 135 135
2020 487 487
2021 211 211

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Cut 457 457
Break 178 178
Unsealed Device Packaging 141 141
Entrapment of Device 100 100
Failure to Deliver Energy 94 94
Detachment of Device or Device Component 64 64
Retraction Problem 63 63
Positioning Problem 56 56
Difficult to Open or Close 55 55
Adverse Event Without Identified Device or Use Problem 44 44
Device Contamination with Chemical or Other Material 41 41
Electrical /Electronic Property Problem 39 39
Detachment Of Device Component 35 35
Defective Device 34 34
Material Twisted/Bent 23 23
Mechanical Problem 18 18
Material Deformation 17 17
Device Operates Differently Than Expected 16 16
Human-Device Interface Problem 11 11
Appropriate Term/Code Not Available 11 11
Material Split, Cut or Torn 8 8
Device-Device Incompatibility 8 8
Failure to Advance 7 7
Use of Device Problem 6 6
Difficult to Advance 6 6
Therapeutic or Diagnostic Output Failure 5 5
Physical Resistance/Sticking 4 4
Device Dislodged or Dislocated 4 4
Device Markings/Labelling Problem 4 4
Activation, Positioning or SeparationProblem 4 4
Device Contaminated During Manufacture or Shipping 3 3
Unintended Movement 3 3
Failure to Fold 3 3
Failure to Conduct 3 3
Positioning Failure 3 3
Overheating of Device 2 2
Device Difficult to Setup or Prepare 2 2
Difficult to Remove 2 2
Failure to Align 2 2
Material Integrity Problem 2 2
Connection Problem 2 2
Device Misassembled During Manufacturing /Shipping 1 1
Material Protrusion/Extrusion 1 1
Output Problem 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Insufficient Information 1 1
Torn Material 1 1
Protective Measures Problem 1 1
Scratched Material 1 1
Off-Label Use 1 1
Separation Failure 1 1
Physical Resistance 1 1
Deformation Due to Compressive Stress 1 1
Suction Problem 1 1
Tear, Rip or Hole in Device Packaging 1 1
Obstruction of Flow 1 1
Structural Problem 1 1
Material Separation 1 1
Inappropriate/Inadequate Shock/Stimulation 1 1
Device Slipped 1 1
Sticking 1 1
Premature Activation 1 1
Device Emits Odor 1 1
Energy Output Problem 1 1
Device Alarm System 1 1
Bent 1 1
Crack 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 186 186
No Patient Involvement 139 139
No Known Impact Or Consequence To Patient 123 123
Hemorrhage/Bleeding 43 43
Perforation 28 28
Tissue Damage 23 23
No Code Available 22 22
Hematoma 8 8
Insufficient Information 7 7
Bowel Perforation 6 6
Burn(s) 5 5
Pain 4 4
Electric Shock 3 3
Blood Loss 2 2
Internal Organ Perforation 2 2
Abdominal Pain 2 2
Foreign Body In Patient 2 2
Device Embedded In Tissue or Plaque 2 2
No Information 2 2
Melena 1 1
Pancreatitis 1 1
Abrasion 1 1
Bowel Burn 1 1
Fever 1 1
Shock 1 1
Stenosis 1 1
Discomfort 1 1
Burn, Thermal 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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