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

MDR Year MDR Reports MDR Events
2019 93 93
2020 31 31
2021 30 30
2022 46 46
2023 35 35
2024 19 19

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 74 74
Device Misassembled During Manufacturing /Shipping 41 41
Defective Device 24 24
Insufficient Heating 12 12
Material Separation 9 9
Break 7 7
Peeled/Delaminated 7 7
Temperature Problem 7 7
Output Problem 6 6
Low impedance 6 6
Detachment of Device or Device Component 6 6
Fluid/Blood Leak 6 6
Material Fragmentation 5 5
Fracture 4 4
Use of Device Problem 4 4
Device Markings/Labelling Problem 3 3
Impedance Problem 3 3
Material Discolored 3 3
Grounding Malfunction 2 2
Smoking 2 2
Nonstandard Device 2 2
Delivered as Unsterile Product 2 2
Structural Problem 2 2
Communication or Transmission Problem 2 2
Sparking 2 2
Biocompatibility 2 2
Contamination /Decontamination Problem 1 1
Malposition of Device 1 1
Defective Component 1 1
Component Missing 1 1
Material Deformation 1 1
Material Integrity Problem 1 1
Device Dislodged or Dislocated 1 1
Overheating of Device 1 1
Problem with Sterilization 1 1
High impedance 1 1
Difficult to Insert 1 1
Insulation failure 1 1
Display or Visual Feedback Problem 1 1
Difficult or Delayed Positioning 1 1
Protective Measures Problem 1 1
Insufficient Information 1 1
Appropriate Term/Code Not Available 1 1
Excessive Heating 1 1
Separation Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Patient Involvement 56 56
No Clinical Signs, Symptoms or Conditions 50 50
Burn(s) 26 26
Foreign Body In Patient 21 21
Spinal Column Injury 20 20
No Consequences Or Impact To Patient 19 19
Vertebral Fracture 18 18
Bone Fracture(s) 18 18
Pain 10 10
Hypersensitivity/Allergic reaction 9 9
No Code Available 7 7
No Known Impact Or Consequence To Patient 7 7
Rash 5 5
Insufficient Information 5 5
Unspecified Infection 4 4
Hematoma 4 4
Device Embedded In Tissue or Plaque 4 4
Superficial (First Degree) Burn 3 3
Hemorrhage/Bleeding 3 3
Inflammation 2 2
Nerve Damage 2 2
Paralysis 2 2
Skin Discoloration 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Local Reaction 1 1
Shock 1 1
Headache 1 1
Death 1 1
Abscess 1 1
Bacterial Infection 1 1
Swelling 1 1
Burning Sensation 1 1
Joint Swelling 1 1
Numbness 1 1
Post Operative Wound Infection 1 1
Low Oxygen Saturation 1 1
No Information 1 1
Foreign Body Embolism 1 1
Respiratory Arrest 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 Epimed International II Apr-16-2020
4 Medtronic Sofamor Danek USA Inc II Jul-23-2020
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