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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device coagulator-cutter, endoscopic, unipolar (and accessories)
Product CodeKNF
Regulation Number 884.4160
Device Class 2


Premarket Reviews
ManufacturerDecision
GYNESONICS, INC
  SUBSTANTIALLY EQUIVALENT 2
GYNESONICS, INC.
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2019 18 18
2020 19 19
2021 9 9
2022 16 16
2023 33 33
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Break 20 20
Material Separation 18 18
Detachment of Device or Device Component 11 11
Sparking 4 4
Melted 4 4
Fire 3 3
Fracture 3 3
Material Fragmentation 3 3
Smoking 3 3
Improper or Incorrect Procedure or Method 3 3
Insufficient Information 3 3
Failure to Cut 3 3
Material Integrity Problem 2 2
Material Twisted/Bent 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Temperature Problem 2 2
Fitting Problem 2 2
Overheating of Device 2 2
Product Quality Problem 1 1
Therapy Delivered to Incorrect Body Area 1 1
Difficult to Remove 1 1
Material Rupture 1 1
Material Frayed 1 1
Mechanical Problem 1 1
Defective Component 1 1
Dull, Blunt 1 1
Patient-Device Incompatibility 1 1
Crack 1 1
Difficult to Open or Close 1 1
Device Contamination with Chemical or Other Material 1 1
Material Deformation 1 1
Patient Device Interaction Problem 1 1
Physical Resistance/Sticking 1 1
Separation Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 35 35
No Consequences Or Impact To Patient 19 19
No Known Impact Or Consequence To Patient 7 7
Insufficient Information 7 7
Foreign Body In Patient 5 5
Partial thickness (Second Degree) Burn 5 5
Burn(s) 5 5
Hemorrhage/Bleeding 4 4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Patient Problem/Medical Problem 1 1
Device Embedded In Tissue or Plaque 1 1
Hormonal Imbalance 1 1
Unspecified Reproductive System or Breast Problem 1 1
Laceration(s) 1 1
Liver Laceration(s) 1 1
Injury 1 1
Electric Shock 1 1
No Patient Involvement 1 1

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