TPLC - Total Product Life Cycle

show TPLC since

Device	probe, radiofrequency lesion
Regulation Description	Radiofrequency lesion probe.
Product Code	GXI
Regulation Number	882.4725
Device Class	2

Premarket Reviews
Manufacturer	Decision
ABBOTT MEDICAL
	SUBSTANTIALLY EQUIVALENT	2
MERIT MEDICAL SYSTEMS, INC.
	SUBSTANTIALLY EQUIVALENT	1
NEUROONE MEDICAL TECHNOLOGIES CORP.
	SUBSTANTIALLY EQUIVALENT	1
RELIEVANT MEDSYSTEMS, INC.
	SUBSTANTIALLY EQUIVALENT	2
SHANGHAI SAMEDICAL & PLASTIC INSTRUMENTS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
STRYKER INSTRUMENTS
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	127	127
Material Fragmentation	36	36
Material Integrity Problem	21	21
Defective Device	17	17
Fracture	14	14
Nonstandard Device	13	13
Use of Device Problem	10	10
Material Separation	8	8
Detachment of Device or Device Component	7	7
Difficult to Remove	7	7
Low impedance	6	6
Insufficient Heating	5	5
Product Quality Problem	5	5
Impedance Problem	5	5
Output Problem	5	5
Break	5	5
Insufficient Information	4	5
High impedance	4	4
Structural Problem	4	4
Difficult to Advance	3	3
Wrong Label	3	3
Component Missing	3	3
Failure to Advance	3	3
Temperature Problem	3	3
Device Markings/Labelling Problem	2	2
Device Misassembled During Manufacturing /Shipping	2	2
Incomplete or Missing Packaging	2	2
Sparking	2	2
Biocompatibility	2	2
Peeled/Delaminated	1	1
Physical Resistance/Sticking	1	1
Communication or Transmission Problem	1	1
Contamination /Decontamination Problem	1	1
Patient Device Interaction Problem	1	1
Malposition of Device	1	1
Thermal Decomposition of Device	1	1
Entrapment of Device	1	1
Lack of Effect	1	1
Difficult or Delayed Positioning	1	1
Delivered as Unsterile Product	1	1
Device Handling Problem	1	1
Separation Problem	1	1
Unexpected Shutdown	1	1
Failure to Deliver Energy	1	1
Device Dislodged or Dislocated	1	1
Disconnection	1	1
Signal Artifact/Noise	1	1
Overheating of Device	1	1
Display or Visual Feedback Problem	1	1
Improper or Incorrect Procedure or Method	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	100	100
Foreign Body In Patient	58	58
Burn(s)	23	23
Insufficient Information	22	22
Vertebral Fracture	21	21
Bone Fracture(s)	20	20
Spinal Column Injury	20	20
Pain	16	16
Hemorrhage/Bleeding	13	14
Low Blood Pressure/ Hypotension	10	10
Headache	6	6
Device Embedded In Tissue or Plaque	5	5
Hypoxia	5	5
Aspiration/Inhalation	5	5
Airway Obstruction	4	4
Respiratory Insufficiency	4	4
Partial thickness (Second Degree) Burn	4	4
Discomfort	4	4
Hematoma	4	4
Hypersensitivity/Allergic reaction	4	4
Dizziness	4	4
Muscle Weakness	3	3
Low Oxygen Saturation	3	3
Unspecified Infection	3	3
Bradycardia	3	3
Vomiting	3	3
Abdominal Pain	2	2
Full thickness (Third Degree) Burn	2	2
Superficial (First Degree) Burn	2	2
Bacterial Infection	2	2
Swelling/ Edema	2	2
Tachycardia	2	2
Dyspnea	2	2
Respiratory Arrest	2	2
Retroperitoneal Hemorrhage	2	2
Movement Disorder	2	2
Skin Discoloration	2	2
Cardiac Arrest	2	2
Perforation	2	2
Exposure to Body Fluids	1	1
Nerve Damage	1	1
Unspecified Mental, Emotional or Behavioural Problem	1	1
Numbness	1	1
Foreign Body Embolism	1	1
No Information	1	1
Needle Stick/Puncture	1	1
Fall	1	1
Dysuria	1	1
Abscess	1	1
Chills	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Boston Scientific Neuromodulation Corporation	II	Jun-11-2026
2	Stryker Corporation	II	Jul-03-2024