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TPLC
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Device
probe, radiofrequency lesion
Regulation Description
Radiofrequency lesion probe.
Product Code
GXI
Regulation Number
882.4725
Device Class
2
Premarket Reviews
Manufacturer
Decision
AVANOS MEDICAL, INC.
SUBSTANTIALLY EQUIVALENT
1
BIOMERICS
SUBSTANTIALLY EQUIVALENT
1
LCCS PRODUCTS LIMITED
SUBSTANTIALLY EQUIVALENT
1
RELIEVANT MEDSYSTEMS, INC.
SUBSTANTIALLY EQUIVALENT
2
SHANGHAI SAMEDICAL & PLASTIC INSTRUMENTS CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2020
31
31
2021
30
30
2022
46
46
2023
35
35
2024
45
45
2025
28
28
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
78
78
Defective Device
16
16
Material Fragmentation
15
15
Material Separation
10
10
Insufficient Heating
8
8
Output Problem
6
6
Detachment of Device or Device Component
6
6
Low impedance
6
6
Break
5
5
Temperature Problem
4
4
Use of Device Problem
4
4
Fracture
4
4
High impedance
3
3
Peeled/Delaminated
3
3
Wrong Label
3
3
Impedance Problem
3
3
Component Missing
3
3
Structural Problem
3
3
Sparking
2
2
Incomplete or Missing Packaging
2
2
Biocompatibility
2
2
Communication or Transmission Problem
2
2
Device Markings/Labelling Problem
2
2
Smoking
2
2
Material Integrity Problem
2
2
Difficult to Remove
2
2
Device Misassembled During Manufacturing /Shipping
2
2
Fluid/Blood Leak
1
1
Improper or Incorrect Procedure or Method
1
1
Insulation failure
1
1
Display or Visual Feedback Problem
1
1
Overheating of Device
1
1
Nonstandard Device
1
1
Excessive Heating
1
1
Protective Measures Problem
1
1
Device Dislodged or Dislocated
1
1
Material Deformation
1
1
Difficult or Delayed Positioning
1
1
Thermal Decomposition of Device
1
1
Difficult to Insert
1
1
Contamination /Decontamination Problem
1
1
Insufficient Information
1
1
Malposition of Device
1
1
Separation Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
70
70
Burn(s)
26
26
Foreign Body In Patient
23
23
Vertebral Fracture
20
20
Spinal Column Injury
20
20
Bone Fracture(s)
19
19
No Consequences Or Impact To Patient
11
11
Insufficient Information
8
8
Pain
7
7
Low Blood Pressure/ Hypotension
6
6
Hemorrhage/Bleeding
5
5
Headache
5
5
No Code Available
5
5
Device Embedded In Tissue or Plaque
4
4
Discomfort
4
4
Rash
4
4
Hematoma
4
4
Dizziness
4
4
Hypersensitivity/Allergic reaction
4
4
Unspecified Infection
4
4
No Patient Involvement
3
3
Airway Obstruction
3
3
Low Oxygen Saturation
3
3
Skin Discoloration
2
2
Paralysis
2
2
Retroperitoneal Hemorrhage
2
2
Respiratory Arrest
2
2
Superficial (First Degree) Burn
2
2
Cardiac Arrest
1
1
Local Reaction
1
1
Post Operative Wound Infection
1
1
Perforation
1
1
Burning Sensation
1
1
Aspiration/Inhalation
1
1
Nerve Damage
1
1
Vomiting
1
1
No Information
1
1
Numbness
1
1
Foreign Body Embolism
1
1
Abscess
1
1
Bradycardia
1
1
Swelling/ Edema
1
1
Hypoxia
1
1
Bacterial Infection
1
1
Death
1
1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
1
1
Abdominal Pain
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Boston Scientific Neuromodulation Corporation
II
Apr-10-2020
2
Epimed International
II
Apr-16-2020
3
Medtronic Sofamor Danek USA Inc
II
Jul-23-2020
4
Stryker Corporation
II
Jul-03-2024
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