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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
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 28 28

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 78 78
Defective Device 16 16
Material Fragmentation 15 15
Material Separation 10 10
Insufficient Heating 8 8
Output Problem 6 6
Detachment of Device or Device Component 6 6
Low impedance 6 6
Break 5 5
Temperature Problem 4 4
Use of Device Problem 4 4
Fracture 4 4
High impedance 3 3
Peeled/Delaminated 3 3
Wrong Label 3 3
Impedance Problem 3 3
Component Missing 3 3
Structural Problem 3 3
Sparking 2 2
Incomplete or Missing Packaging 2 2
Biocompatibility 2 2
Communication or Transmission Problem 2 2
Device Markings/Labelling Problem 2 2
Smoking 2 2
Material Integrity Problem 2 2
Difficult to Remove 2 2
Device Misassembled During Manufacturing /Shipping 2 2
Fluid/Blood Leak 1 1
Improper or Incorrect Procedure or Method 1 1
Insulation failure 1 1
Display or Visual Feedback Problem 1 1
Overheating of Device 1 1
Nonstandard Device 1 1
Excessive Heating 1 1
Protective Measures Problem 1 1
Device Dislodged or Dislocated 1 1
Material Deformation 1 1
Difficult or Delayed Positioning 1 1
Thermal Decomposition of Device 1 1
Difficult to Insert 1 1
Contamination /Decontamination Problem 1 1
Insufficient Information 1 1
Malposition of Device 1 1
Separation Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 70 70
Burn(s) 26 26
Foreign Body In Patient 23 23
Vertebral Fracture 20 20
Spinal Column Injury 20 20
Bone Fracture(s) 19 19
No Consequences Or Impact To Patient 11 11
Insufficient Information 8 8
Pain 7 7
Low Blood Pressure/ Hypotension 6 6
Hemorrhage/Bleeding 5 5
Headache 5 5
No Code Available 5 5
Device Embedded In Tissue or Plaque 4 4
Discomfort 4 4
Rash 4 4
Hematoma 4 4
Dizziness 4 4
Hypersensitivity/Allergic reaction 4 4
Unspecified Infection 4 4
No Patient Involvement 3 3
Airway Obstruction 3 3
Low Oxygen Saturation 3 3
Skin Discoloration 2 2
Paralysis 2 2
Retroperitoneal Hemorrhage 2 2
Respiratory Arrest 2 2
Superficial (First Degree) Burn 2 2
Cardiac Arrest 1 1
Local Reaction 1 1
Post Operative Wound Infection 1 1
Perforation 1 1
Burning Sensation 1 1
Aspiration/Inhalation 1 1
Nerve Damage 1 1
Vomiting 1 1
No Information 1 1
Numbness 1 1
Foreign Body Embolism 1 1
Abscess 1 1
Bradycardia 1 1
Swelling/ Edema 1 1
Hypoxia 1 1
Bacterial Infection 1 1
Death 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Abdominal Pain 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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