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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
Product CodeKGE
Regulation Number 876.4300
Device Class 2


Premarket Reviews
ManufacturerDecision
FUJIFILM CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
FUJIFILM MEDICAL SYSTEMS U.S.A., INC.
  SUBSTANTIALLY EQUIVALENT 1
HANGZHOU AGS MEDTECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
MICRO-TECH (NANJING) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
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
2017 26 26
2018 27 27
2019 15 15
2020 7 7
2021 24 24
2022 13 13

Device Problems MDRs with this Device Problem Events in those MDRs
Tear, Rip or Hole in Device Packaging 27 27
Failure to Align 9 9
Difficult to Open or Close 7 7
Adverse Event Without Identified Device or Use Problem 7 7
Illegible Information 7 7
Unintended Movement 6 6
Device Operates Differently Than Expected 5 5
Break 4 4
Insufficient Heating 3 3
Mechanical Problem 3 3
Dull, Blunt 3 3
Use of Device Problem 3 3
Failure to Power Up 3 3
Material Separation 3 3
Material Twisted/Bent 3 3
Mechanical Jam 3 3
No Apparent Adverse Event 2 2
Material Deformation 2 2
Failure to Cut 2 2
Communication or Transmission Problem 2 2
Detachment of Device or Device Component 2 2
Intermittent Loss of Power 2 2
Suction Failure 2 2
Activation Problem 1 1
Failure to Clean Adequately 1 1
Unexpected Shutdown 1 1
Bent 1 1
Difficult to Advance 1 1
Device Handling Problem 1 1
Noise, Audible 1 1
Complete Loss of Power 1 1
Output Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Inappropriate/Inadequate Shock/Stimulation 1 1
Off-Label Use 1 1
Solder Joint Fracture 1 1
Overheating of Device 1 1
Loose or Intermittent Connection 1 1
Detachment Of Device Component 1 1
Failure to Deliver Shock/Stimulation 1 1
Failure to Deliver Energy 1 1
Fracture 1 1
Material Fragmentation 1 1
Material Frayed 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Patient Involvement 29 29
No Consequences Or Impact To Patient 28 28
No Clinical Signs, Symptoms or Conditions 28 28
No Known Impact Or Consequence To Patient 8 8
Hemorrhage/Bleeding 5 5
Perforation 5 5
No Information 3 3
Blood Loss 3 3
Insufficient Information 2 2
Laceration(s) of Esophagus 1 1
Unspecified Tissue Injury 1 1
Tissue Damage 1 1
Vomiting 1 1
Infiltration into Tissue 1 1
Pain 1 1

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