TPLC - Total Product Life Cycle

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Device	generator, lesion, radiofrequency
Regulation Description	Radiofrequency lesion generator.
Product Code	GXD
Regulation Number	882.4400
Device Class	2

Premarket Reviews
Manufacturer	Decision
ABBOTT MEDICAL
	SUBSTANTIALLY EQUIVALENT	2
AVANOS MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	2
BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
EPIMED INTERNATIONAL
	SUBSTANTIALLY EQUIVALENT	1
NEUROONE MEDICAL TECHNOLOGIES CORP.
	SUBSTANTIALLY EQUIVALENT	1
RF INNOVATIONS, INC.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Insufficient Heating	109	109
Fracture	77	77
Output Problem	68	68
Adverse Event Without Identified Device or Use Problem	59	59
Thermal Decomposition of Device	39	39
Communication or Transmission Problem	32	32
Temperature Problem	29	29
Connection Problem	25	25
Smoking	24	24
Unexpected Shutdown	22	22
Failure to Deliver Energy	18	18
Device Emits Odor	15	15
High impedance	15	15
Failure to Power Up	13	13
Overheating of Device	13	13
Insufficient Device Problem Information	12	12
Noise, Audible	11	11
Therapeutic or Diagnostic Output Failure	10	10
Mechanical Problem	9	9
Grounding Malfunction	9	9
Unintended Electrical Shock	7	7
Impedance Problem	6	6
Degraded	6	6
No Display/Image	6	6
Power Problem	5	5
Defective Device	4	4
Display or Visual Feedback Problem	4	4
Structural Problem	3	3
Use of Device Problem	3	3
Energy Output Problem	3	3
Sparking	2	2
Loss of Threshold	2	2
Defibrillation/Stimulation Problem	2	2
Electrical /Electronic Property Problem	2	2
Disconnection	2	2
No Tactile Prompts/Feedback	2	2
Patient Device Interaction Problem	2	2
Device Handling Problem	2	2
Appropriate Device Problem Term/Code Not Available	2	2
No Apparent Adverse Event	2	2
Fluid/Blood Leak	1	1
Fire	1	1
Erratic or Intermittent Display	1	1
Loose or Intermittent Connection	1	1
Break	1	1
Nonstandard Device	1	1
Loss of or Failure to Bond	1	1
Audible Prompt/Feedback Problem	1	1
Intermittent Loss of Power	1	1
Device Remains Activated	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	419	419
No Consequences Or Impact To Patient	108	108
Partial thickness (Second Degree) Burn	35	35
Burn(s)	17	18
Pain	16	16
Full thickness (Third Degree) Burn	10	10
Superficial (First Degree) Burn	8	15
No Known Impact Or Consequence To Patient	8	8
Insufficient Information	7	7
Electric Shock	6	6
No Patient Involvement	4	4
Inadequate Pain Relief	4	4
Muscle Weakness/Atrophy	4	4
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	3	3
Foreign Body In Patient	3	3
No Information	3	3
Burning Sensation	3	3
Erythema	2	2
Spinal Cord Injury	2	2
Speech Disorder	2	2
Peeling	1	1
Discomfort	1	1
Not Applicable	1	1
Unspecified Nervous System Problem	1	1
Emotional Changes	1	1
Fever	1	1
Osteomyelitis	1	1
Fall	1	1
Fatigue	1	1
Paraplegia	1	1
No Code Available	1	1
Bacterial Infection	1	1
Paresthesia	1	1
High Blood Pressure/ Hypertension	1	1
Constipation	1	1
Burn, Thermal	1	1
Cramp(s) /Muscle Spasm(s)	1	1
Numbness	1	1
Arrhythmia	1	1
Blister	1	1
Cellulitis	1	1
Ambulation or Postural Difficulties	1	1
Shock	1	1
Cardiac Arrest	1	1
Urinary Retention	1	1
Shock from Patient Lead(s)	1	1
Chest Pain	1	1
Nerve Damage	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Abbott	II	Nov-02-2023
2	Abbott Laboratories Inc. (St Jude Medical)	II	May-10-2021
3	Avanos Medical, Inc.	II	Sep-21-2023