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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 1
AVANOS MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
BAYLIS MEDICAL COMPANY INC.
  SUBSTANTIALLY EQUIVALENT 1
RELIEVANT MEDSYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
STRYKER CORPORATION
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2016 51 51
2017 83 83
2018 156 156
2019 197 197
2020 138 138
2021 123 123

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 140 140
Temperature Problem 93 93
Insufficient Heating 84 84
Communication or Transmission Problem 55 55
Failure to Power Up 44 44
Output Problem 43 43
Device Operates Differently Than Expected 31 31
Unexpected Shutdown 30 30
Smoking 25 25
Material Deformation 24 24
Thermal Decomposition of Device 23 23
Failure to Deliver Energy 20 20
Insufficient Information 20 20
Noise, Audible 18 18
Impedance Problem 18 18
High impedance 14 14
Device Emits Odor 14 14
Device Displays Incorrect Message 13 13
Overheating of Device 11 11
No Display/Image 11 11
Unintended Electrical Shock 10 10
Display or Visual Feedback Problem 7 7
Power Problem 6 6
Material Separation 5 5
Device Remains Activated 4 4
Mechanical Problem 4 4
Improper or Incorrect Procedure or Method 4 4
Therapeutic or Diagnostic Output Failure 4 4
Intermittent Communication Failure 4 4
Low impedance 3 3
Energy Output Problem 3 3
Inappropriate/Inadequate Shock/Stimulation 3 3
Computer Software Problem 3 3
Electrical /Electronic Property Problem 3 3
Loose or Intermittent Connection 2 2
Display Difficult to Read 2 2
Erratic or Intermittent Display 2 2
Device Alarm System 2 2
Loss of Threshold 2 2
Device Inoperable 2 2
Use of Device Problem 2 2
Break 2 2
Connection Problem 2 2
Environmental Compatibility Problem 2 2
Failure to Disconnect 2 2
Failure to Shut Off 2 2
Separation Problem 2 2
Application Program Freezes, Becomes Nonfunctional 2 2
No Tactile Prompts/Feedback 2 2
Appropriate Term/Code Not Available 2 2
No Apparent Adverse Event 1 1
Intermittent Loss of Power 1 1
Excessive Heating 1 1
Audible Prompt/Feedback Problem 1 1
Tactile Prompts/Feedback 1 1
Failure of Device to Self-Test 1 1
Improper Device Output 1 1
Detachment of Device or Device Component 1 1
Device Operational Issue 1 1
Electrical Power Problem 1 1
Structural Problem 1 1
Sparking 1 1
No Device Output 1 1
Loss of Power 1 1
Therapy Delivered to Incorrect Body Area 1 1
Device Stops Intermittently 1 1
Failure to Analyze Signal 1 1
No Audible Alarm 1 1
Detachment Of Device Component 1 1
Electromagnetic Interference 1 1
Energy Output To Patient Tissue Incorrect 1 1
Fire 1 1
Fluid Leak 1 1
Fracture 1 1
Grounding Malfunction 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 402 402
No Clinical Signs, Symptoms or Conditions 133 133
Burn(s) 94 94
Partial thickness (Second Degree) Burn 53 53
No Known Impact Or Consequence To Patient 29 29
No Patient Involvement 27 27
Pain 11 11
Full thickness (Third Degree) Burn 7 7
Burning Sensation 4 4
Inadequate Pain Relief 4 4
Insufficient Information 4 4
No Information 4 4
Discomfort 3 3
Burn, Thermal 3 3
Shock 3 3
Tissue Damage 2 2
Muscle Weakness 2 2
Erythema 2 2
Fever 2 2
Electric Shock 2 2
Numbness 2 2
Spinal Cord Injury 1 1
Shaking/Tremors 1 1
Superficial (First Degree) Burn 1 1
Foreign Body In Patient 1 1
Device Embedded In Tissue or Plaque 1 1
Not Applicable 1 1
Fistula 1 1
Flatus 1 1
Inflammation 1 1
Irritation 1 1
Necrosis 1 1
Device Overstimulation of Tissue 1 1
Crushing Injury 1 1
Urinary Retention 1 1
Weakness 1 1
Skin Erosion 1 1
Swelling 1 1
Perforation 1 1
Staphylococcus Aureus 1 1
Seizures 1 1
No Code Available 1 1
Constipation 1 1
Paresthesia 1 1
Osteomyelitis 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
3 Neurotherm, Inc. II Apr-09-2016
4 Stryker Instruments Div. of Stryker Corporation III Nov-16-2016
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