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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search show TPLC since Back to Search Results
Device forceps, biopsy, electric
Regulation Description Endoscopic electrosurgical unit and accessories.
Product CodeKGE
Regulation Number 876.4300
Device Class 2


Premarket Reviews
ManufacturerDecision
FUJIFILM MEDICAL SYSTEM U.S.A., INC.
  SUBSTANTIALLY EQUIVALENT 1
FUJIFILM MEDICAL SYSTEMS U.S.A., INC.
  SUBSTANTIALLY EQUIVALENT 2
HANGZHOU AGS MEDTECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
MICRO-TECH (NANJING) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
OLYMPUS MEDICAL SYSTEMS CORP.
  SUBSTANTIALLY EQUIVALENT 1
SLATER ENDOSCOPY, LLC
  SUBSTANTIALLY EQUIVALENT 1
STERIS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
WILSON-COOK MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2016 9 9
2017 26 26
2018 27 27
2019 15 15
2020 7 7
2021 22 22

Device Problems MDRs with this Device Problem Events in those MDRs
Tear, Rip or Hole in Device Packaging 27 27
Failure to Align 11 11
Difficult to Open or Close 8 8
Device Operates Differently Than Expected 7 7
Illegible Information 7 7
Adverse Event Without Identified Device or Use Problem 5 5
Dull, Blunt 3 3
Use of Device Problem 3 3
Mechanical Problem 3 3
Material Separation 3 3
Break 3 3
Insufficient Heating 3 3
Material Twisted/Bent 3 3
Mechanical Jam 3 3
Suction Failure 2 2
Bent 2 2
Failure to Deliver Energy 2 2
No Apparent Adverse Event 2 2
Failure to Cut 2 2
Communication or Transmission Problem 2 2
Detachment of Device or Device Component 2 2
Failure to Fire 1 1
Difficult to Advance 1 1
Device Contamination with Chemical or Other Material 1 1
Material Protrusion/Extrusion 1 1
Device Handling Problem 1 1
Noise, Audible 1 1
Complete Loss of Power 1 1
Unexpected Shutdown 1 1
Output Problem 1 1
Positioning Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Fracture 1 1
Material Fragmentation 1 1
Material Frayed 1 1
Loose or Intermittent Connection 1 1
Detachment Of Device Component 1 1
Inappropriate/Inadequate Shock/Stimulation 1 1
Off-Label Use 1 1
Out-Of-Box Failure 1 1
Solder Joint Fracture 1 1
Activation Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 33 33
No Patient Involvement 30 30
No Clinical Signs, Symptoms or Conditions 16 16
No Known Impact Or Consequence To Patient 10 10
Perforation 4 4
Hemorrhage/Bleeding 4 4
Blood Loss 3 3
No Information 3 3
Insufficient Information 2 2
Tissue Damage 1 1
Vomiting 1 1
Infiltration into Tissue 1 1
Laceration(s) 1 1
Pain 1 1

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