TPLC - Total Product Life Cycle

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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	1
RELIEVANT MEDSYSTEMS, INC.
	SUBSTANTIALLY EQUIVALENT	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	86	86
Device Misassembled During Manufacturing /Shipping	41	41
Defective Device	24	24
Insufficient Heating	12	12
Material Separation	9	9
Temperature Problem	7	7
Break	7	7
Peeled/Delaminated	7	7
Fluid/Blood Leak	6	6
Output Problem	6	6
Structural Problem	6	6
Detachment of Device or Device Component	6	6
Low impedance	6	6
Material Fragmentation	5	5
Use of Device Problem	5	5
Fracture	4	4
Device Markings/Labelling Problem	3	3
Wrong Label	3	3
Impedance Problem	3	3
Material Discolored	3	3
Sparking	2	2
Biocompatibility	2	2
Communication or Transmission Problem	2	2
Smoking	2	2
Overheating of Device	2	2
Nonstandard Device	2	2
Grounding Malfunction	2	2
Delivered as Unsterile Product	2	2
Improper or Incorrect Procedure or Method	1	1
Insulation failure	1	1
Display or Visual Feedback Problem	1	1
Excessive Heating	1	1
Appropriate Term/Code Not Available	1	1
Protective Measures Problem	1	1
Device Dislodged or Dislocated	1	1
Material Deformation	1	1
Difficult or Delayed Positioning	1	1
Problem with Sterilization	1	1
Component Missing	1	1
Difficult to Insert	1	1
Contamination /Decontamination Problem	1	1
Material Integrity Problem	1	1
Defective Component	1	1
Insufficient Information	1	1
Malposition of Device	1	1
High impedance	1	1
Separation Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	59	59
No Patient Involvement	56	56
Burn(s)	32	32
Foreign Body In Patient	21	21
Spinal Column Injury	20	20
Bone Fracture(s)	19	19
No Consequences Or Impact To Patient	19	19
Vertebral Fracture	18	18
Pain	11	11
Hypersensitivity/Allergic reaction	9	9
No Code Available	7	7
No Known Impact Or Consequence To Patient	7	7
Insufficient Information	6	6
Hematoma	5	5
Rash	5	5
Headache	5	5
Device Embedded In Tissue or Plaque	4	4
Unspecified Infection	4	4
Dizziness	4	4
Hemorrhage/Bleeding	4	4
Discomfort	4	4
Superficial (First Degree) Burn	3	3
Low Oxygen Saturation	2	2
Respiratory Arrest	2	2
Low Blood Pressure/ Hypotension	2	2
Inflammation	2	2
Skin Discoloration	2	2
Paralysis	2	2
Nerve Damage	2	2
Airway Obstruction	1	1
Bacterial Infection	1	1
Partial thickness (Second Degree) Burn	1	1
Swelling/ Edema	1	1
Shock	1	1
Abscess	1	1
Foreign Body Embolism	1	1
Numbness	1	1
Joint Swelling	1	1
Swelling	1	1
Burning Sensation	1	1
Post Operative Wound Infection	1	1
Cardiac Arrest	1	1
Local Reaction	1	1
No Information	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	Abbott Medical	II	Dec-20-2019
2	Boston Scientific Neuromodulation Corporation	II	Apr-10-2020
3	Epimed International	II	Apr-16-2020
4	Medtronic Sofamor Danek USA Inc	II	Jul-23-2020
5	Stryker Corporation	II	Jul-03-2024