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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
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

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

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 72 72
Defective Device 16 16
Material Separation 9 9
Insufficient Heating 8 8
Output Problem 6 6
Detachment of Device or Device Component 6 6
Low impedance 6 6
Temperature Problem 4 4
Break 4 4
Material Fragmentation 4 4
Use of Device Problem 4 4
Fracture 4 4
Peeled/Delaminated 3 3
Wrong Label 3 3
Impedance Problem 3 3
Structural Problem 3 3
Sparking 2 2
Biocompatibility 2 2
Communication or Transmission Problem 2 2
Device Markings/Labelling Problem 2 2
Smoking 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
Component Missing 1 1
Difficult to Insert 1 1
Contamination /Decontamination Problem 1 1
Difficult to Remove 1 1
Insufficient Information 1 1
Malposition of Device 1 1
High impedance 1 1
Separation Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 56 56
Burn(s) 26 26
Spinal Column Injury 20 20
Bone Fracture(s) 19 19
Foreign Body In Patient 19 19
Vertebral Fracture 18 18
No Consequences Or Impact To Patient 11 11
Pain 7 7
Insufficient Information 6 6
No Code Available 5 5
Headache 5 5
Device Embedded In Tissue or Plaque 4 4
Unspecified Infection 4 4
Hypersensitivity/Allergic reaction 4 4
Dizziness 4 4
Hematoma 4 4
Hemorrhage/Bleeding 4 4
Rash 4 4
Discomfort 4 4
Low Blood Pressure/ Hypotension 3 3
No Patient Involvement 3 3
Superficial (First Degree) Burn 2 2
Low Oxygen Saturation 2 2
Respiratory Arrest 2 2
Skin Discoloration 2 2
Paralysis 2 2
Retroperitoneal Hemorrhage 2 2
Airway Obstruction 1 1
Bacterial Infection 1 1
Swelling/ Edema 1 1
Bradycardia 1 1
Abscess 1 1
Foreign Body Embolism 1 1
Numbness 1 1
Nerve Damage 1 1
Burning Sensation 1 1
Post Operative Wound Infection 1 1
Cardiac Arrest 1 1
Local Reaction 1 1
Perforation 1 1
No Information 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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