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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device probe, radiofrequency lesion
Regulation Description Radiofrequency lesion probe.
Product CodeGXI
Regulation Number 882.4725
Device Class 2


Premarket Reviews
ManufacturerDecision
AVANOS MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
  1.  K203066  COOLIEF Cooled Radiofrequency Kit Advanced
BIOMERICS
  SUBSTANTIALLY EQUIVALENT 1
LCCS PRODUCTS LIMITED
  SUBSTANTIALLY EQUIVALENT 1
RELIEVANT MEDSYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 2
SHANGHAI SAMEDICAL & PLASTIC INSTRUMENTS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 31 31
2021 30 30
2022 46 46
2023 35 35
2024 45 45
2025 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 73 73
Defective Device 16 16
Material Separation 9 9
Insufficient Heating 8 8
Low impedance 6 6
Detachment of Device or Device Component 6 6
Output Problem 6 6
Break 5 5
Material Fragmentation 4 4
Temperature Problem 4 4
Fracture 4 4
Use of Device Problem 4 4
Peeled/Delaminated 3 3
Impedance Problem 3 3
Wrong Label 3 3
Structural Problem 3 3
Communication or Transmission Problem 2 2
Biocompatibility 2 2
Device Misassembled During Manufacturing /Shipping 2 2
Smoking 2 2
Sparking 2 2
Device Markings/Labelling Problem 2 2
Excessive Heating 1 1
Component Missing 1 1
Difficult to Remove 1 1
Difficult or Delayed Positioning 1 1
Material Deformation 1 1
Fluid/Blood Leak 1 1
Protective Measures Problem 1 1
High impedance 1 1
Improper or Incorrect Procedure or Method 1 1
Overheating of Device 1 1
Insulation failure 1 1
Nonstandard Device 1 1
Contamination /Decontamination Problem 1 1
Device Dislodged or Dislocated 1 1
Difficult to Insert 1 1
Insufficient Information 1 1
Malposition of Device 1 1
Separation Problem 1 1
Thermal Decomposition of Device 1 1
Display or Visual Feedback Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 56 56
Burn(s) 27 27
Spinal Column Injury 20 20
Foreign Body In Patient 20 20
Bone Fracture(s) 19 19
Vertebral Fracture 18 18
No Consequences Or Impact To Patient 11 11
Pain 8 8
Insufficient Information 8 8
No Code Available 5 5
Headache 5 5
Hematoma 4 4
Rash 4 4
Hemorrhage/Bleeding 4 4
Discomfort 4 4
Hypersensitivity/Allergic reaction 4 4
Device Embedded In Tissue or Plaque 4 4
Dizziness 4 4
Unspecified Infection 4 4
Low Blood Pressure/ Hypotension 3 3
No Patient Involvement 3 3
Respiratory Arrest 2 2
Superficial (First Degree) Burn 2 2
Retroperitoneal Hemorrhage 2 2
Paralysis 2 2
Low Oxygen Saturation 2 2
Skin Discoloration 2 2
Swelling/ Edema 1 1
Burning Sensation 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Numbness 1 1
Local Reaction 1 1
Cardiac Arrest 1 1
Bradycardia 1 1
Foreign Body Embolism 1 1
Death 1 1
Post Operative Wound Infection 1 1
Abdominal Pain 1 1
Airway Obstruction 1 1
Bacterial Infection 1 1
Nerve Damage 1 1
No Information 1 1
Perforation 1 1
Abscess 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Boston Scientific Neuromodulation Corporation II Apr-10-2020
2 Epimed International II Apr-16-2020
3 Medtronic Sofamor Danek USA Inc II Jul-23-2020
4 Stryker Corporation II Jul-03-2024
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