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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
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
CHENG MEDICAL, CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
DIROS TECHNOLOGY, INC.
  SUBSTANTIALLY EQUIVALENT 1
NEUROONE MEDICAL TECHNOLOGIES CORP.
  SUBSTANTIALLY EQUIVALENT 1
NEUROTHERM, INC.
  SUBSTANTIALLY EQUIVALENT 1
RELIEVANT MEDSYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
RF INNOVATIONS, INC
  SUBSTANTIALLY EQUIVALENT 1
STRYKER CORPORATION
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 64 64
2015 67 67
2016 51 51
2017 83 83
2018 156 156
2019 195 195
2020 138 138
2021 154 154
2022 84 84
2023 54 54
2024 11 11

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 187 187
Insufficient Heating 115 115
Temperature Problem 112 112
Output Problem 73 73
Communication or Transmission Problem 65 65
Device Operates Differently Than Expected 53 53
Failure to Power Up 49 49
Thermal Decomposition of Device 43 43
Unexpected Shutdown 34 34
Smoking 33 33
Device Displays Incorrect Message 32 32
Impedance Problem 25 25
Failure to Deliver Energy 25 25
Insufficient Information 25 25
Material Deformation 24 24
Noise, Audible 20 20
High impedance 18 18
Overheating of Device 17 17
No Display/Image 16 16
Device Emits Odor 15 15
Device Inoperable 12 12
Unintended Electrical Shock 10 10
Improper or Incorrect Procedure or Method 9 9
Mechanical Problem 9 9
Fracture 8 8
Display or Visual Feedback Problem 8 8
Power Problem 8 8
Therapeutic or Diagnostic Output Failure 7 7
Connection Problem 7 7
Electrical /Electronic Property Problem 6 6
Grounding Malfunction 6 6
Energy Output Problem 6 6
Material Separation 6 6
Inappropriate/Inadequate Shock/Stimulation 5 5
Device Remains Activated 4 4
Computer Software Problem 4 4
Low impedance 4 4
Appropriate Term/Code Not Available 4 4
Intermittent Communication Failure 4 4
No Apparent Adverse Event 3 3
Application Program Freezes, Becomes Nonfunctional 3 3
Use of Device Problem 3 3
Defective Device 3 3
Break 3 3
Erratic or Intermittent Display 3 3
Loss of Power 3 3
No Device Output 2 2
Loose or Intermittent Connection 2 2
Disconnection 2 2
Display Difficult to Read 2 2
Device Alarm System 2 2
Loss of Threshold 2 2
Failure to Disconnect 2 2
Sparking 2 2
Device Sensing Problem 2 2
Environmental Compatibility Problem 2 2
Failure to Shut Off 2 2
Separation Problem 2 2
No Tactile Prompts/Feedback 2 2
Excessive Heating 1 1
Fail-Safe Did Not Operate 1 1
Audible Prompt/Feedback Problem 1 1
Tactile Prompts/Feedback 1 1
Protective Measures Problem 1 1
Intermittent Loss of Power 1 1
Human-Device Interface Problem 1 1
Failure of Device to Self-Test 1 1
Improper Device Output 1 1
Positioning Problem 1 1
Electrical Power Problem 1 1
Device Operational Issue 1 1
Detachment of Device or Device Component 1 1
Computer Operating System Problem 1 1
Wrinkled 1 1
Patient-Device Incompatibility 1 1
Application Program Problem 1 1
Arcing 1 1
Sticking 1 1
Device Stops Intermittently 1 1
Incorrect Or Inadequate Test Results 1 1
Structural Problem 1 1
Device Damaged Prior to Use 1 1
No Audible Alarm 1 1
Circuit Failure 1 1
Detachment Of Device Component 1 1
Application Interface Becomes Non-Functional Or Program Exits Abnormally 1 1
Electromagnetic Interference 1 1
Energy Output To Patient Tissue Incorrect 1 1
Fire 1 1
Fluid/Blood Leak 1 1
Failure to Analyze Signal 1 1
Failure to Sense 1 1
Device Difficult to Setup or Prepare 1 1
Therapy Delivered to Incorrect Body Area 1 1
Defibrillation/Stimulation Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 411 411
No Clinical Signs, Symptoms or Conditions 276 276
Burn(s) 133 133
Partial thickness (Second Degree) Burn 72 72
No Known Impact Or Consequence To Patient 64 64
Therapeutic Effects, Unexpected 29 29
No Patient Involvement 28 28
Burning Sensation 18 18
Pain 18 18
Full thickness (Third Degree) Burn 12 12
No Information 6 6
Electric Shock 6 6
Superficial (First Degree) Burn 6 6
Insufficient Information 5 5
No Code Available 4 4
Burn, Thermal 4 4
Inadequate Pain Relief 4 4
Discomfort 4 4
Erythema 4 4
Muscle Weakness 3 3
Shock 3 3
Necrosis 2 2
Fever 2 2
Impaired Healing 2 2
Tissue Damage 2 2
Numbness 2 2
Spinal Cord Injury 2 2
Foreign Body In Patient 2 2
Shaking/Tremors 1 1
Sleep Dysfunction 1 1
Urinary Retention 1 1
Weakness 1 1
Thrombus 1 1
Anxiety 1 1
Fistula 1 1
Flatus 1 1
Inflammation 1 1
Irritation 1 1
Cellulitis 1 1
Crushing Injury 1 1
Awareness during Anaesthesia 1 1
Bacterial Infection 1 1
Radiation Burn 1 1
Device Overstimulation of Tissue 1 1
Skin Erosion 1 1
Swelling 1 1
Peeling 1 1
Perforation 1 1
Staphylococcus Aureus 1 1
Seizures 1 1
Constipation 1 1
Speech Disorder 1 1
Paresthesia 1 1
Cramp(s) /Muscle Spasm(s) 1 1
Osteomyelitis 1 1
Shock from Patient Lead(s) 1 1
Device Embedded In Tissue or Plaque 1 1
Not Applicable 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 Abbott Medical II Dec-10-2019
4 Avanos Medical, Inc. II Sep-21-2023
5 Neurotherm, Inc. II Apr-09-2016
6 Stryker Instruments Div. of Stryker Corporation III Nov-16-2016
7 Stryker Instruments Div. of Stryker Corporation II Jan-18-2011
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