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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)
Regulation Description Unipolar endoscopic coagulator-cutter and accessories.
Product CodeKNF
Regulation Number 884.4160
Device Class 2


Premarket Reviews
ManufacturerDecision
GYNESONICS, INC
  SUBSTANTIALLY EQUIVALENT 3
GYNESONICS, INC.
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2020 19 19
2021 9 9
2022 16 16
2023 33 33
2024 13 13
2025 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Break 23 23
Detachment of Device or Device Component 11 11
Material Separation 7 7
Adverse Event Without Identified Device or Use Problem 6 6
Insufficient Information 4 4
Melted 4 4
Improper or Incorrect Procedure or Method 3 3
Failure to Cut 3 3
Material Fragmentation 3 3
Smoking 3 3
Sparking 3 3
Fracture 3 3
Mechanical Problem 2 2
Excessive Heating 2 2
Overheating of Device 2 2
Fire 2 2
Material Integrity Problem 2 2
Fitting Problem 2 2
Material Frayed 1 1
Material Twisted/Bent 1 1
Crack 1 1
Defective Component 1 1
Dull, Blunt 1 1
Patient Device Interaction Problem 1 1
Material Rupture 1 1
Physical Resistance/Sticking 1 1
Difficult to Remove 1 1
Material Deformation 1 1
Patient-Device Incompatibility 1 1
Device Contamination with Chemical or Other Material 1 1
Therapy Delivered to Incorrect Body Area 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 40 40
No Consequences Or Impact To Patient 8 8
Burn(s) 7 7
Insufficient Information 7 7
Partial thickness (Second Degree) Burn 6 6
Foreign Body In Patient 4 4
Hemorrhage/Bleeding 4 4
No Known Impact Or Consequence To Patient 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Sepsis 2 2
Unspecified Reproductive System or Breast Problem 2 2
Bowel Burn 2 2
Unspecified Tissue Injury 1 1
No Patient Involvement 1 1
Bowel Perforation 1 1
Device Embedded In Tissue or Plaque 1 1
Patient Problem/Medical Problem 1 1
Laceration(s) 1 1
Electric Shock 1 1
Hormonal Imbalance 1 1

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