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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device generator, lesion, radiofrequency
Regulation Description Radiofrequency lesion generator.
Product CodeGXD
Regulation Number 882.4400
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT MEDICAL
  SUBSTANTIALLY EQUIVALENT 2
AVANOS MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
EPIMED INTERNATIONAL
  SUBSTANTIALLY EQUIVALENT 1
NEUROONE MEDICAL TECHNOLOGIES CORP.
  SUBSTANTIALLY EQUIVALENT 1
RF INNOVATIONS, INC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 138 138
2021 154 154
2022 84 84
2023 54 54
2024 64 64
2025 11 11

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Heating 98 98
Output Problem 64 64
Adverse Event Without Identified Device or Use Problem 53 53
Fracture 40 40
Thermal Decomposition of Device 39 39
Communication or Transmission Problem 31 31
Smoking 24 24
Temperature Problem 24 24
Unexpected Shutdown 21 21
Failure to Deliver Energy 18 18
Device Emits Odor 15 15
Failure to Power Up 13 13
High impedance 12 12
Overheating of Device 12 12
Insufficient Information 11 11
Noise, Audible 11 11
Connection Problem 9 9
Mechanical Problem 8 8
Unintended Electrical Shock 7 7
Grounding Malfunction 6 6
No Display/Image 6 6
Power Problem 5 5
Impedance Problem 5 5
Defective Device 4 4
Display or Visual Feedback Problem 4 4
Energy Output Problem 3 3
Structural Problem 3 3
Device Handling Problem 2 2
Disconnection 2 2
Loss of Threshold 2 2
Use of Device Problem 2 2
Defibrillation/Stimulation Problem 2 2
No Apparent Adverse Event 2 2
Electrical /Electronic Property Problem 2 2
Degraded 2 2
Appropriate Term/Code Not Available 2 2
No Tactile Prompts/Feedback 2 2
Intermittent Loss of Power 1 1
Application Program Freezes, Becomes Nonfunctional 1 1
Low impedance 1 1
Detachment of Device or Device Component 1 1
Patient-Device Incompatibility 1 1
Lack of Effect 1 1
Fail-Safe Did Not Operate 1 1
Fluid/Blood Leak 1 1
Fire 1 1
Audible Prompt/Feedback Problem 1 1
Improper or Incorrect Procedure or Method 1 1
Break 1 1
Sparking 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 330 330
No Consequences Or Impact To Patient 108 108
Partial thickness (Second Degree) Burn 32 32
Burn(s) 15 15
Pain 11 11
No Known Impact Or Consequence To Patient 8 8
Superficial (First Degree) Burn 7 7
Full thickness (Third Degree) Burn 7 7
Electric Shock 5 5
Insufficient Information 5 5
Inadequate Pain Relief 4 4
No Patient Involvement 4 4
Muscle Weakness 4 4
No Information 3 3
Spinal Cord Injury 2 2
Speech Disorder 2 2
Burning Sensation 2 2
Erythema 2 2
Numbness 1 1
Paraplegia 1 1
Burn, Thermal 1 1
Foreign Body In Patient 1 1
Shock from Patient Lead(s) 1 1
Not Applicable 1 1
No Code Available 1 1
Constipation 1 1
Movement Disorder 1 1
Paresthesia 1 1
Peeling 1 1
Shock 1 1
Urinary Retention 1 1
Bacterial Infection 1 1
Cellulitis 1 1
Fever 1 1
Bone Fracture(s) 1 1
Cramp(s) /Muscle Spasm(s) 1 1
Osteomyelitis 1 1
Blister 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Abbott II Nov-02-2023
2 Abbott Laboratories Inc. (St Jude Medical) II May-10-2021
3 Avanos Medical, Inc. II Sep-21-2023
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