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


Premarket Reviews
ManufacturerDecision
ABBOTT MEDICAL
  SUBSTANTIALLY EQUIVALENT 2
AVANOS MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
BAYLIS MEDICAL COMPANY INC.
  SUBSTANTIALLY EQUIVALENT 1
RF INNOVATIONS, INC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2018 156 156
2019 197 197
2020 138 138
2021 154 154
2022 84 84
2023 25 25

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 110 110
Insufficient Heating 106 106
Temperature Problem 79 79
Output Problem 66 66
Communication or Transmission Problem 64 64
Failure to Power Up 44 44
Thermal Decomposition of Device 39 39
Unexpected Shutdown 33 33
Smoking 32 32
Failure to Deliver Energy 24 24
Material Deformation 24 24
Noise, Audible 17 17
Overheating of Device 15 15
Device Emits Odor 15 15
High impedance 14 14
Impedance Problem 12 12
Insufficient Information 11 11
Device Operates Differently Than Expected 10 10
Unintended Electrical Shock 10 10
No Display/Image 9 9
Power Problem 8 8
Display or Visual Feedback Problem 8 8
Mechanical Problem 7 7
Fracture 6 6
Device Displays Incorrect Message 6 6
Connection Problem 6 6
Material Separation 5 5
Intermittent Communication Failure 4 4
Energy Output Problem 4 4
Low impedance 3 3
Application Program Freezes, Becomes Nonfunctional 3 3
Use of Device Problem 3 3
Defective Device 3 3
Break 2 2
No Tactile Prompts/Feedback 2 2
Separation Problem 2 2
Loose or Intermittent Connection 2 2
Disconnection 2 2
Erratic or Intermittent Display 2 2
Failure to Disconnect 2 2
Environmental Compatibility Problem 2 2
Loss of Threshold 2 2
Therapeutic or Diagnostic Output Failure 2 2
Appropriate Term/Code Not Available 2 2
Electrical /Electronic Property Problem 2 2
Device Remains Activated 2 2
Improper or Incorrect Procedure or Method 2 2
Inappropriate/Inadequate Shock/Stimulation 1 1
Device Stops Intermittently 1 1
Fail-Safe Did Not Operate 1 1
Sparking 1 1
Patient-Device Incompatibility 1 1
Energy Output To Patient Tissue Incorrect 1 1
Fire 1 1
Device Operational Issue 1 1
No Apparent Adverse Event 1 1
Structural Problem 1 1
Failure of Device to Self-Test 1 1
Excessive Heating 1 1
Protective Measures Problem 1 1
Intermittent Loss of Power 1 1
Electromagnetic Interference 1 1
Application Program Problem 1 1
Loss of Power 1 1
Grounding Malfunction 1 1
Failure to Analyze Signal 1 1
Audible Prompt/Feedback Problem 1 1
Tactile Prompts/Feedback 1 1
Detachment of Device or Device Component 1 1
No Device Output 1 1
Fluid/Blood Leak 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 351 351
No Clinical Signs, Symptoms or Conditions 246 246
Burn(s) 54 54
Partial thickness (Second Degree) Burn 51 51
No Patient Involvement 26 26
No Known Impact Or Consequence To Patient 15 15
Pain 11 11
Full thickness (Third Degree) Burn 9 9
Superficial (First Degree) Burn 6 6
Insufficient Information 4 4
Inadequate Pain Relief 4 4
No Information 4 4
Burn, Thermal 3 3
Electric Shock 2 2
Muscle Weakness 2 2
Burning Sensation 2 2
Spinal Cord Injury 2 2
Foreign Body In Patient 2 2
Not Applicable 1 1
No Code Available 1 1
Constipation 1 1
Cellulitis 1 1
Shock 1 1
Urinary Retention 1 1
Osteomyelitis 1 1
Inflammation 1 1
Device Overstimulation of Tissue 1 1
Peeling 1 1
Paresthesia 1 1
Cramp(s) /Muscle Spasm(s) 1 1
Bacterial Infection 1 1
Irritation 1 1
Discomfort 1 1
Erythema 1 1
Fever 1 1
Staphylococcus Aureus 1 1
Numbness 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Laboratories Inc. (St Jude Medical) II May-10-2021
2 Abbott Medical II Dec-10-2019
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