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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 6

MDR Year MDR Reports MDR Events
2020 19 19
2021 9 9
2022 16 16
2023 33 35
2024 13 13
2025 93 93

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 78 78
Break 34 34
Detachment of Device or Device Component 14 14
Material Separation 7 7
Insufficient Information 4 6
Smoking 4 4
Melted 4 4
Sparking 3 3
Fire 3 3
Material Fragmentation 3 3
Failure to Cut 3 3
Fracture 3 3
Improper or Incorrect Procedure or Method 3 3
Fitting Problem 2 2
Mechanical Problem 2 2
Material Disintegration 2 2
Material Integrity Problem 2 2
Lack of Effect 2 2
Excessive Heating 2 2
Overheating of Device 2 2
Material Frayed 1 1
Physical Resistance/Sticking 1 1
Crack 1 1
Patient-Device Incompatibility 1 1
Defective Component 1 1
Difficult to Remove 1 1
Patient Device Interaction Problem 1 1
Material Twisted/Bent 1 1
Material Rupture 1 1
Material Deformation 1 1
Device Contamination with Chemical or Other Material 1 1
Connection Problem 1 1
Therapy Delivered to Incorrect Body Area 1 1
Dull, Blunt 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 54 54
Fever 28 28
Unspecified Infection 22 22
Unspecified Reproductive System or Breast Problem 15 15
Abnormal Vaginal Discharge 14 14
Insufficient Information 11 11
No Consequences Or Impact To Patient 8 8
Menstrual Irregularities 7 7
Burn(s) 7 7
Partial thickness (Second Degree) Burn 6 8
Hemorrhage/Bleeding 5 5
Sepsis 4 4
Foreign Body In Patient 4 4
Urinary Retention 4 4
Urinary Tract Infection 4 4
Bowel Burn 3 3
No Known Impact Or Consequence To Patient 3 3
Laceration(s) 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Constipation 2 2
Leiomyosarcoma 2 2
Unintended Radiation Exposure 2 2
Abdominal Pain 1 1
Uterine Perforation 1 1
Patient Problem/Medical Problem 1 1
Electric Shock 1 1
Bowel Perforation 1 1
Inflammation 1 1
Intermenstrual Bleeding 1 1
No Patient Involvement 1 1
Dyspnea 1 1
Tachycardia 1 1
Unspecified Tissue Injury 1 1
Thrombocytopenia 1 1
Headache 1 1
Hormonal Imbalance 1 1
Low Blood Pressure/ Hypotension 1 1
Device Embedded In Tissue or Plaque 1 1

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