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TPLC
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show TPLC since
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Device
probe, radiofrequency lesion
Product Code
GXI
Regulation Number
882.4725
Device Class
2
Premarket Reviews
Manufacturer
Decision
AVANOS MEDICAL, INC.
SUBSTANTIALLY EQUIVALENT
1
BIOMERICS
SUBSTANTIALLY EQUIVALENT
1
BOSTON SCIENTIFIC CORPORATION
SUBSTANTIALLY EQUIVALENT
1
EPIMED INTERNATIONAL, INC.
SUBSTANTIALLY EQUIVALENT
1
LCCS PRODUCTS LIMITED
SUBSTANTIALLY EQUIVALENT
1
RELIEVANT MEDSYSTEMS
SUBSTANTIALLY EQUIVALENT
2
RELIEVANT MEDSYSTEMS, INC.
SUBSTANTIALLY EQUIVALENT
2
MDR Year
MDR Reports
MDR Events
2018
147
147
2019
91
91
2020
31
31
2021
30
30
2022
47
47
2023
8
8
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
89
89
Material Separation
50
50
Device Misassembled During Manufacturing /Shipping
41
41
Insufficient Heating
35
35
Defective Device
32
32
Break
18
18
Temperature Problem
14
14
Material Discolored
10
10
Peeled/Delaminated
7
7
Fracture
7
7
Material Fragmentation
6
6
Fluid/Blood Leak
6
6
Low impedance
6
6
Output Problem
6
6
Use of Device Problem
5
5
Communication or Transmission Problem
5
5
Detachment of Device or Device Component
5
5
Smoking
5
5
Device Markings/Labelling Problem
3
3
Impedance Problem
3
3
Sparking
2
2
Grounding Malfunction
2
2
Nonstandard Device
2
2
Delivered as Unsterile Product
2
2
High impedance
2
2
Appropriate Term/Code Not Available
2
2
Contamination /Decontamination Problem
2
2
Excessive Heating
1
1
Separation Problem
1
1
Protective Measures Problem
1
1
No Apparent Adverse Event
1
1
Insufficient Information
1
1
Difficult to Insert
1
1
Insulation failure
1
1
Melted
1
1
Display or Visual Feedback Problem
1
1
Difficult or Delayed Positioning
1
1
Overheating of Device
1
1
Problem with Sterilization
1
1
Malposition of Device
1
1
Biocompatibility
1
1
Improper or Incorrect Procedure or Method
1
1
Defective Component
1
1
Component Missing
1
1
Manufacturing, Packaging or Shipping Problem
1
1
Material Deformation
1
1
Material Integrity Problem
1
1
Device Dislodged or Dislocated
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Known Impact Or Consequence To Patient
77
77
No Patient Involvement
64
64
No Consequences Or Impact To Patient
55
55
No Clinical Signs, Symptoms or Conditions
39
39
Hypersensitivity/Allergic reaction
31
31
Burn(s)
27
27
Spinal Column Injury
15
15
Bone Fracture(s)
14
14
Vertebral Fracture
13
13
Foreign Body In Patient
9
9
Pain
9
9
No Code Available
8
8
Rash
5
5
Hematoma
5
5
Unspecified Infection
4
4
Skin Irritation
4
4
Insufficient Information
3
3
Superficial (First Degree) Burn
3
3
Bruise/Contusion
2
2
Paralysis
2
2
Inflammation
2
2
Itching Sensation
2
2
Nerve Damage
2
2
Hemorrhage/Bleeding
1
1
Death
1
1
Local Reaction
1
1
Shock
1
1
Swelling
1
1
Burning Sensation
1
1
Full thickness (Third Degree) Burn
1
1
No Information
1
1
Joint Swelling
1
1
Numbness
1
1
Post Operative Wound Infection
1
1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
1
1
Foreign Body Embolism
1
1
Swelling/ Edema
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Abbott Medical
II
Dec-20-2019
2
Boston Scientific Neuromodulation Corporation
II
Apr-10-2020
3
Cosman Medical, LLC
II
Feb-22-2018
4
Epimed International
II
Apr-16-2020
5
Medtronic Sofamor Danek USA Inc
II
Jul-23-2020
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