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	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	110	110
Material Fragmentation	24	24
Defective Device	17	17
Material Integrity Problem	11	11
Use of Device Problem	9	9
Material Separation	7	7
Low impedance	6	6
Fracture	6	6
Detachment of Device or Device Component	6	6
Insufficient Heating	5	5
Break	5	5
Output Problem	5	5
Difficult to Remove	5	5
High impedance	4	4
Impedance Problem	4	4
Temperature Problem	3	3
Nonstandard Device	3	3
Structural Problem	3	3
Component Missing	3	3
Wrong Label	3	3
Insufficient Information	2	3
Difficult to Advance	2	2
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
Contamination /Decontamination Problem	1	1
Patient Device Interaction Problem	1	1
Peeled/Delaminated	1	1
Physical Resistance/Sticking	1	1
Communication or Transmission Problem	1	1
Thermal Decomposition of Device	1	1
Malposition of Device	1	1
Lack of Effect	1	1
Difficult or Delayed Positioning	1	1
Device Handling Problem	1	1
Entrapment of Device	1	1
Separation Problem	1	1
Unexpected Shutdown	1	1
Device Dislodged or Dislocated	1	1
Failure to Deliver Energy	1	1
Disconnection	1	1
Overheating of Device	1	1
Display or Visual Feedback Problem	1	1
Improper or Incorrect Procedure or Method	1	1
Deformation Due to Compressive Stress	1	1
Fluid/Blood Leak	1	1
Signal Artifact/Noise	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	79	79
Foreign Body In Patient	42	42
Burn(s)	23	23
Vertebral Fracture	21	21
Bone Fracture(s)	20	20
Spinal Column Injury	20	20
Insufficient Information	18	18
Pain	15	15
Hemorrhage/Bleeding	10	11
Low Blood Pressure/ Hypotension	9	9
Headache	6	6
Device Embedded In Tissue or Plaque	5	5
Airway Obstruction	4	4
Hypersensitivity/Allergic reaction	4	4
Respiratory Insufficiency	4	4
Dizziness	4	4
Hematoma	4	4
Discomfort	4	4
Unspecified Infection	3	3
Low Oxygen Saturation	3	3
Partial thickness (Second Degree) Burn	3	3
Muscle Weakness	3	3
Bradycardia	3	3
Full thickness (Third Degree) Burn	2	2
Hypoxia	2	2
Swelling/ Edema	2	2
Vomiting	2	2
Retroperitoneal Hemorrhage	2	2
Movement Disorder	2	2
Skin Discoloration	2	2
Perforation	2	2
Aspiration/Inhalation	2	2
Respiratory Arrest	2	2
Superficial (First Degree) Burn	2	2
Abdominal Pain	2	2
Unspecified Mental, Emotional or Behavioural Problem	1	1
Numbness	1	1
Foreign Body Embolism	1	1
Post Operative Wound Infection	1	1
Fall	1	1
Abscess	1	1
Cardiac Arrest	1	1
Limb Fracture	1	1
Local Reaction	1	1
Aneurysm	1	1
Bacterial Infection	1	1
Presyncope	1	1
No Information	1	1
Arrhythmia	1	1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Stryker Corporation	II	Jul-03-2024