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TPLC
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show TPLC since
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2023
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Device
generator, lesion, radiofrequency
Product Code
GXD
Regulation Number
882.4400
Device Class
2
Premarket Reviews
Manufacturer
Decision
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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