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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Super Search Devices@FDA
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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
BEIJING ZKSK TECHNOLOGY CO.,LTD
  SUBSTANTIALLY EQUIVALENT 1
FUJIFILM CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
HANGZHOU AGS MEDTECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
MICRO-TECH (NANJING) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 7 7
2021 24 24
2022 16 16
2023 8 8
2024 9 9

Device Problems MDRs with this Device Problem Events in those MDRs
Unintended Movement 13 13
Adverse Event Without Identified Device or Use Problem 10 10
Illegible Information 7 7
Insufficient Heating 3 3
Mechanical Jam 3 3
Material Twisted/Bent 3 3
Failure to Power Up 3 3
Failure to Align 2 2
Suction Failure 2 2
Complete Loss of Power 2 2
Communication or Transmission Problem 2 2
Overheating of Device 2 2
Material Deformation 2 2
Dull, Blunt 2 2
Intermittent Loss of Power 2 2
Break 2 2
Mechanical Problem 2 2
Failure to Cut 2 2
Energy Output Problem 1 1
Failure to Deliver Shock/Stimulation 1 1
Unexpected Shutdown 1 1
Difficult to Open or Close 1 1
Failure to Clean Adequately 1 1
Noise, Audible 1 1
Off-Label Use 1 1
Packaging Problem 1 1
Device Contaminated During Manufacture or Shipping 1 1
Use of Device Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 42 42
Perforation 6 6
Hemorrhage/Bleeding 6 6
No Consequences Or Impact To Patient 5 5
No Known Impact Or Consequence To Patient 3 3
Insufficient Information 2 2
Laceration(s) of Esophagus 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Unspecified Tissue Injury 1 1
Bacterial Infection 1 1
Pain 1 1
Gastrointestinal Hemorrhage 1 1

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