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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
BOSTON SCIENTIFIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
EPIMED INTERNATIONAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
LCCS PRODUCTS LIMITED
  SUBSTANTIALLY EQUIVALENT 1
RELIEVANT MEDSYSTEMS
  SUBSTANTIALLY EQUIVALENT 2
RELIEVANT MEDSYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2018 147 147
2019 91 91
2020 31 31
2021 30 30
2022 47 47
2023 8 8

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 89 89
Material Separation 50 50
Device Misassembled During Manufacturing /Shipping 41 41
Insufficient Heating 35 35
Defective Device 32 32
Break 18 18
Temperature Problem 14 14
Material Discolored 10 10
Peeled/Delaminated 7 7
Fracture 7 7
Material Fragmentation 6 6
Fluid/Blood Leak 6 6
Low impedance 6 6
Output Problem 6 6
Use of Device Problem 5 5
Communication or Transmission Problem 5 5
Detachment of Device or Device Component 5 5
Smoking 5 5
Device Markings/Labelling Problem 3 3
Impedance Problem 3 3
Sparking 2 2
Grounding Malfunction 2 2
Nonstandard Device 2 2
Delivered as Unsterile Product 2 2
High impedance 2 2
Appropriate Term/Code Not Available 2 2
Contamination /Decontamination Problem 2 2
Excessive Heating 1 1
Separation Problem 1 1
Protective Measures Problem 1 1
No Apparent Adverse Event 1 1
Insufficient Information 1 1
Difficult to Insert 1 1
Insulation failure 1 1
Melted 1 1
Display or Visual Feedback Problem 1 1
Difficult or Delayed Positioning 1 1
Overheating of Device 1 1
Problem with Sterilization 1 1
Malposition of Device 1 1
Biocompatibility 1 1
Improper or Incorrect Procedure or Method 1 1
Defective Component 1 1
Component Missing 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Material Deformation 1 1
Material Integrity Problem 1 1
Device Dislodged or Dislocated 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 77 77
No Patient Involvement 64 64
No Consequences Or Impact To Patient 55 55
No Clinical Signs, Symptoms or Conditions 39 39
Hypersensitivity/Allergic reaction 31 31
Burn(s) 27 27
Spinal Column Injury 15 15
Bone Fracture(s) 14 14
Vertebral Fracture 13 13
Foreign Body In Patient 9 9
Pain 9 9
No Code Available 8 8
Rash 5 5
Hematoma 5 5
Unspecified Infection 4 4
Skin Irritation 4 4
Insufficient Information 3 3
Superficial (First Degree) Burn 3 3
Bruise/Contusion 2 2
Paralysis 2 2
Inflammation 2 2
Itching Sensation 2 2
Nerve Damage 2 2
Hemorrhage/Bleeding 1 1
Death 1 1
Local Reaction 1 1
Shock 1 1
Swelling 1 1
Burning Sensation 1 1
Full thickness (Third Degree) Burn 1 1
No Information 1 1
Joint Swelling 1 1
Numbness 1 1
Post Operative Wound Infection 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Foreign Body Embolism 1 1
Swelling/ Edema 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Medical II Dec-20-2019
2 Boston Scientific Neuromodulation Corporation II Apr-10-2020
3 Cosman Medical, LLC II Feb-22-2018
4 Epimed International II Apr-16-2020
5 Medtronic Sofamor Danek USA Inc II Jul-23-2020
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