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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search show TPLC since Back to Search Results
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
DIROS TECHNOLOGY INC.
  SUBSTANTIALLY EQUIVALENT 1
EPIMED INTERNATIONAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
HALYARD HEALTH, INC.
  SUBSTANTIALLY EQUIVALENT 1
LCCS PRODUCTS LIMITED
  SUBSTANTIALLY EQUIVALENT 1
RELIEVANT MEDSYSTEMS
  SUBSTANTIALLY EQUIVALENT 3
RELIEVANT MEDSYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 150 150
2018 147 147
2019 91 91
2020 31 31
2021 30 30
2022 27 27

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 97 97
Break 86 86
Material Separation 67 67
Material Discolored 53 53
Device Misassembled During Manufacturing /Shipping 40 40
Insufficient Heating 34 34
Contamination /Decontamination Problem 29 29
Defective Device 27 27
Temperature Problem 21 21
Material Erosion 15 15
Leak/Splash 13 13
Peeled/Delaminated 8 8
No Apparent Adverse Event 7 7
Output Problem 6 6
Fluid Leak 6 6
Fracture 6 6
Material Fragmentation 6 6
Detachment of Device or Device Component 6 6
Communication or Transmission Problem 5 5
Smoking 5 5
Use of Device Problem 5 5
Crack 3 3
High impedance 3 3
Melted 2 2
Nonstandard Device 2 2
Delivered as Unsterile Product 2 2
Grounding Malfunction 2 2
Sparking 2 2
Device Markings/Labelling Problem 2 2
Appropriate Term/Code Not Available 2 2
Excessive Heating 1 1
Insufficient Information 1 1
Protective Measures Problem 1 1
Device Dislodged or Dislocated 1 1
Device Contamination with Chemical or Other Material 1 1
Impedance Problem 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Material Deformation 1 1
Material Integrity Problem 1 1
Material Protrusion/Extrusion 1 1
Malposition of Device 1 1
Biocompatibility 1 1
Device Disinfection Or Sterilization Issue 1 1
Improper or Incorrect Procedure or Method 1 1
Defective Component 1 1
Component Missing 1 1
Device Contamination with Body Fluid 1 1
Residue After Decontamination 1 1
Device Issue 1 1
Problem with Sterilization 1 1
Electrical /Electronic Property Problem 1 1
Difficult or Delayed Positioning 1 1
Corroded 1 1
Overheating of Device 1 1
Difficult to Insert 1 1
Insulation failure 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 197 197
No Patient Involvement 65 65
No Consequences Or Impact To Patient 64 64
Hypersensitivity/Allergic reaction 34 34
Burn(s) 28 28
No Clinical Signs, Symptoms or Conditions 25 25
Spinal Column Injury 12 12
Bone Fracture(s) 11 11
Vertebral Fracture 10 10
Rash 9 9
No Code Available 8 8
Foreign Body In Patient 7 7
Pain 7 7
Skin Irritation 5 5
Itching Sensation 4 4
Local Reaction 4 4
Hematoma 4 4
Bacterial Infection 4 4
Unspecified Infection 3 3
Inflammation 3 3
Superficial (First Degree) Burn 3 3
Death 2 2
Swelling 2 2
Insufficient Information 2 2
Hemorrhage/Bleeding 2 2
Bruise/Contusion 2 2
Nerve Damage 2 2
Paralysis 2 2
Staphylococcus Aureus 1 1
Shock 1 1
Cardiac Arrest 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Foreign Body Embolism 1 1
Full thickness (Third Degree) Burn 1 1
No Information 1 1
Burning Sensation 1 1
Joint Swelling 1 1
Numbness 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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